Safety, Tolerability, and Antiviral Activity of ACH-01416... | NCT01180790 | Trialant
NCT01180790
Sponsor
Alexion Pharmaceuticals, Inc.
Status
Completed
Last Update Posted
Aug 30, 2023Actual
Enrollment
122Actual
Phase
Phase 2
Conditions
Hepatitis C
Interventions
ACH-0141625 (Sovaprevir)
ACH-0141625 (Sovaprevir)
ACH-0141625 (Sovaprevir)
Placebo
Pegylated Interferon alpha-2a
Ribavirin
Countries
United States
Belgium
Protocol Section
Identification Module
NCT ID
NCT01180790
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ACH625-003
Secondary IDs
ID
Type
Description
Link
2010-022092-65
EudraCT Number
Brief Title
Safety, Tolerability, and Antiviral Activity of ACH-0141625 or Placebo in Combination With Peginterferon and Ribavirin in Hepatitis C Virus (HCV) Positive Participants
Official Title
A Phase IIa, Randomized, Double-blind (Participant and Investigator Blind, Sponsor Open), Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Antiviral Activity of Oral ACH-0141625 in Combination With Pegylated Interferon Alpha-2a and Ribavirin in Two Segments, After 28 Days of Dosing and, Subsequently, After 12 Weeks of Dosing in Participants With Chronic Hepatitis C Virus Genotype 1
Acronym
Not provided
Organization
Alexion Pharmaceuticals, Inc.INDUSTRY
Status Module
Record Verification Date
Aug 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 2010
Primary Completion Date
Mar 2012Actual
Completion Date
Apr 2013Actual
First Submitted Date
Aug 11, 2010
First Submission Date that Met QC Criteria
Aug 11, 2010
First Posted Date
Aug 12, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 29, 2014
Results First Submitted that Met QC Criteria
Sep 8, 2014
Results First Posted Date
Sep 10, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Aug 7, 2023
Last Update Posted Date
Aug 30, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Alexion Pharmaceuticals, Inc.INDUSTRY
Collaborators
Name
Class
Achillion, a wholly owned subsidiary of Alexion
INDUSTRY
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
Evaluate safety, tolerability, and antiviral response of ACH-0141625 compared to standard of care in hepatitis C virus (HCV)-positive participants.
Detailed Description
Not provided
Conditions Module
Conditions
Hepatitis C
Keywords
HCV
Hepatitis C Genotype 1
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
122Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Segment 1: 200 milligrams (mg) ACH-0141625
Experimental
200 mg ACH-0141625 for 28 days plus pegylated interferon (Peg-IFN) alpha-2a and ribavirin (RBV) for 48 weeks
Drug: ACH-0141625 (Sovaprevir)
Drug: Pegylated Interferon alpha-2a
Drug: Ribavirin
Segment 1: 400 mg ACH-0141625
Experimental
400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
Drug: ACH-0141625 (Sovaprevir)
Drug: Pegylated Interferon alpha-2a
Drug: Ribavirin
Segment 1: 800 mg ACH-0141625
Experimental
800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
Drug: ACH-0141625 (Sovaprevir)
Drug: Pegylated Interferon alpha-2a
Drug: Ribavirin
Segment 1: Placebo
Placebo Comparator
Placebo for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
Drug: Placebo
Drug: Pegylated Interferon alpha-2a
Drug: Ribavirin
Segment 2: 200 mg ACH-0141625
Experimental
200 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ACH-0141625 (Sovaprevir)
Drug
200 mg oral capsule once daily
Segment 1: 200 milligrams (mg) ACH-0141625
Segment 2: 200 mg ACH-0141625
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Segment 1: Safety
Segment 1: Percentage of participants with the following: adverse events, abnormal laboratory safety tests, dose reductions, interruptions, and discontinuations. Criteria for abnormal laboratory safety tests: treatment-emergent worsening Division of AIDS (Acquired Immunodeficiency Syndrome) (DAIDs) graded laboratory tests. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
4 weeks
Segment 1: Rapid Viral Response At Week 4 (RVR4)
The primary efficacy endpoint for Segment 1 of the study was the percentage of participants in each treatment group achieving RVR4 (hepatitis C virus [HCV] ribonucleic acid (RNA) less than or equal to the limit of quantitation [LOQ] at the Week 4 visit).
4 weeks
Segment 2: Safety
Segment 2: Percentage of participants with the following: adverse events, abnormal laboratory safety tests and dose reductions, interruptions and discontinuations. Criteria for abnormal laboratory safety tests: treatment-emergent worsening DAIDs graded laboratory tests. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
12 weeks
Segment 2: Complete Early Virologic Response (cEVR)
The primary efficacy endpoint for Segment 2 of the study was the percentage of participants achieving cEVR, defined as undetectable HCV RNA at Week 12.
Week 12
Secondary Outcomes
Measure
Description
Time Frame
Segment 1: cEVR
For Segment 1, the percentage of participants in the virology population who achieved cEVR, defined as undetectable HCV RNA at Week 12.
12 weeks
Segment 2: RVR4
For Segment 2, the percentage of participants in the virology population who achieved RVR4, defined as HCV RNA less than or equal to the LOQ at the Week 4 visit.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Males and females, aged 18 years and older
Chronic hepatitis C genotype 1 (as specified in the protocol)
Treatment naive
Females who are post-menopausal and amenorrheic must have a follicle-stimulating hormone (FSH) at screening. Females of childbearing potential must have a negative pregnancy test at screening and baseline. Females must use a non-hormonal method of contraception and must agree not to get pregnant during the study and for 6 months following the discontinuation of standard of care (SOC).
Fertile males must agree to use a condom and his female partner must agree to use 1 or more methods of contraception. Males must not donate sperm during the study and 3 months following the last exposure to RBV.
Exclusion Criteria:
Body mass index (BMI) >36 kilograms (kg)/square meter (m^2)
Pregnant or nursing females or females of childbearing potential not willing to comply with contraceptive measures per protocol. Men whose female partners are pregnant or contemplating pregnancy. - Coinfection with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV)
Other significant diseases including liver disease
History of drug or alcohol dependence or addiction within the past 6 months
History of participation in a clinical trial with a protease inhibitor or previous treatment with a protease inhibitor, where at least 1 dose of the protease inhibitor was consumed.
Use of herbal or homeopathic products, illicit drugs, cytochrome P450 (CYP) 3A4/5 substrates, inducers or inhibitors, hormonal methods of contraception, corticosteroids, immunosuppressive, or cytotoxic agents within 28 days of the first dose of study drug.
Have a clinically significant laboratory abnormality at screening (as specified in the protocol).
Segment 1: Participants with any history of decompensated liver disease defined as cirrhotic participants with a Child-Pugh score of > or = to 7. Segment 2: Participants who have had a liver biopsy that shows bridging fibrosis or cirrhosis.
Nonalcoholic steatohepatitis if ballooning degeneration or Mallory bodies are present on liver biopsy.
Participants who prematurely discontinued, interrupted, or dose reduced prior Peg-IFN and RBV therapy due to noncompliance or safety issues.
Encephalopathy or altered mental status of any etiology.
History of moderate, severe, or uncontrolled psychiatric disease (as specified in the protocol).
History of malignancy of any organ system treated or untreated within the past 5 years.
Use of colony stimulating factor agents within 90 days prior to baseline.
History of seizure disorder.
History of known coagulopathy including hemophilia.
Clinically of significant findings on fundoscopic or retinal examination at screening
History of immunologically mediate disease.
History of clinical evidence of chronic cardiac disease (as specified in the protocol)
Received concomitant systemic antibiotic, antifungals, or antivirals for the treatment of active infection within 14 days prior to the first dose of the study drug (as specified in the protocol)
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Clinical Trial Site
Los Angeles
California
90036
United States
Clinical Trial Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Participants were screened within 4 weeks (Day -28 to Day -1) before administration of the study drug. Participants who meet all eligibility criteria were instructed to arrive at the study center on Baseline day for randomization to treatment assignment.
Recruitment Details
Participants were recruited from 15 sites in the United States and 3 sites in Belgium between 30 September 2010 and 03 January 2012.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Segment 1: 200 Milligrams (mg) ACH-0141625 for 28 Days
ACH-0141625: 200 mg oral capsule once daily
Pegylated Interferon (Peg-IFN) alpha-2a: 180 micrograms (ug) once a week by subcutaneous injection for 48 weeks
Ribavirin (RBV): 400 mg or 600 mg (morning [AM]) and 600 mg (evening [PM]) capsules taken orally twice daily for 48 weeks
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Germany
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug: ACH-0141625 (Sovaprevir)
Drug: Pegylated Interferon alpha-2a
Drug: Ribavirin
Segment 2 : 400 mg ACH-0141625
Experimental
400 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
Drug: ACH-0141625 (Sovaprevir)
Drug: Pegylated Interferon alpha-2a
Drug: Ribavirin
Segment 2 : 800 mg ACH-0141625
Experimental
800 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
Drug: ACH-0141625 (Sovaprevir)
Drug: Pegylated Interferon alpha-2a
Drug: Ribavirin
ACH-0141625 (Sovaprevir)
Drug
400 mg oral capsule once daily
Segment 1: 400 mg ACH-0141625
Segment 2 : 400 mg ACH-0141625
ACH-0141625 (Sovaprevir)
Drug
800 mg oral capsule once daily
Segment 1: 800 mg ACH-0141625
Segment 2 : 800 mg ACH-0141625
Placebo
Drug
Powder in capsule once daily
Segment 1: Placebo
Pegylated Interferon alpha-2a
Drug
180 micrograms (ug) once a week by subcutaneous injection
Segment 1: 200 milligrams (mg) ACH-0141625
Segment 1: 400 mg ACH-0141625
Segment 1: 800 mg ACH-0141625
Segment 1: Placebo
Segment 2 : 400 mg ACH-0141625
Segment 2 : 800 mg ACH-0141625
Segment 2: 200 mg ACH-0141625
Peg-INF
Ribavirin
Drug
400 mg or 600 mg (morning [AM]) and 600 mg (evening [PM]) capsules taken orally twice daily
Segment 1: 200 milligrams (mg) ACH-0141625
Segment 1: 400 mg ACH-0141625
Segment 1: 800 mg ACH-0141625
Segment 1: Placebo
Segment 2 : 400 mg ACH-0141625
Segment 2 : 800 mg ACH-0141625
Segment 2: 200 mg ACH-0141625
Ribasphere
Copegus
4 weeks
Segment 1 And Segment 2: End Of Treatment Response
The percentage of virology population participants who were reported as undetectable HCV RNA at the completion of treatment.
The percentage of virology population participants who achieved sustained virologic response (SVR), defined as HCV RNA less than the LOQ, at 12 weeks (3 months) post-dosing.
The percentage of virology population participants who achieved SVR, defined as HCV RNA less than the LOQ, 6 months post-dosing.
6 months post-dosing
Segment 1 And Segment 2: HCV RNA Change From Baseline
The mean change from baseline in log10 HCV RNA level by visit for the virology population
Week 4
Segment 1 And Segment 2: HCV RNA Change From Baseline
Change from baseline in log10 HCV RNA level by visit.
Week 12
Los Angeles
California
90048
United States
Clinical Trial Site
San Francisco
California
94115
United States
Clinical Trial Site
Bradenton
Florida
34209
United States
Clinical Trial Site
Orlando
Florida
32803
United States
Clinical Trial Site
Chicago
Illinois
60611
United States
Clinical Trial Site
Overland Park
Kansas
66211
United States
Clinical Trial Site
St Louis
Missouri
63104
United States
Clinical Trial Site
Las Vegas
Nevada
89106
United States
Clinical Trial Site
New York
New York
10065
United States
Clinical Trial Site
Philadelphia
Pennsylvania
19141
United States
Clinical Trial Site
Arlington
Texas
76012
United States
Clinical Trial Site
San Antonio
Texas
78215
United States
Clinical Trial Site
Newport News
Virginia
23602
United States
Clinical Trial Site
Norfolk
Virginia
23502
United States
Clinical Trial Site
Edegem
Antwerp
2650
Belgium
Clinical Trial Site
Haine-Saint-Paul
Hainaut
7100
Belgium
Clinical Trial Site
Ghent
Oost-Vlaanderen
9000
Belgium
FG001
Segment 1: 400 mg ACH-0141625 for 28 Days
ACH-0141625: 400 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
FG002
Segment 1: 800 mg ACH-0141625 for 28 Days
ACH-0141625: 800 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
FG003
Segment 1: Placebo for 28 Days
Placebo: Powder in capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
FG004
Segment 2: 200 mg ACH-0141625 for 12 Weeks
ACH-0141625: 200 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for up to 24 or 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for up to 24 or 48 weeks
FG005
Segment 2: 400 mg ACH-0141625 for 12 Weeks
ACH-0141625: 400 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for up to 24 or 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for up to 24 or 48 weeks
FG006
Segment 2: 800 mg ACH-0141625 for 12 Weeks
ACH-0141625: 800 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for up to 24 or 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for up to 24 or 48 weeks
FG00016 subjects
FG00116 subjects
FG00217 subjects
FG00315 subjects
FG00419 subjects
FG00520 subjects
FG00619 subjects
COMPLETED
FG0007 subjects
FG00111 subjects
FG0024 subjects
FG0036 subjects
FG00414 subjects
FG00513 subjects
FG00618 subjects
NOT COMPLETED
FG0009 subjects
FG0015 subjects
FG00213 subjects
FG0039 subjects
FG0045 subjects
FG0057 subjects
FG0061 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG0041 subjects
FG0053 subjects
FG0060 subjects
Withdrawal by Subject
FG0003 subjects
FG0010 subjects
FG0025 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0003 subjects
FG0011 subjects
FG0020 subjects
FG0032 subjects
FG004
Physician Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Lack of Efficacy
FG0001 subjects
FG0012 subjects
FG0025 subjects
FG0036 subjects
FG004
compliance
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Severe coronary atherosclerosis (death)
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
The intent-to-treat (ITT) population, which was defined as all participants randomized and treated with at least 1 dose of ACH 0141625 or Placebo. Participants were analyzed according to the randomized treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Segment 1: 200 mg ACH-0141625
200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and RBV for 48 weeks
ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
BG001
Segment 1: 400 mg ACH-0141625
400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
BG002
Segment 1: 800 mg ACH-0141625
800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
BG003
Segment 1: Placebo
Placebo for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
Placebo: Powder in capsule once daily for 28 days
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
BG004
Segment 2: 200 mg ACH-0141625
200 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 48 weeks
ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
BG005
Segment 2: 400 mg ACH-0141625
400 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 48 weeks
ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
BG006
Segment 2: 800 mg ACH-0141625
800 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 48 weeks
ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00016
BG00116
BG00217
BG00315
BG00419
BG00520
BG00619
BG007122
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00051± 7
BG00151± 9
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0016
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Segment 1: Safety
Segment 1: Percentage of participants with the following: adverse events, abnormal laboratory safety tests, dose reductions, interruptions, and discontinuations. Criteria for abnormal laboratory safety tests: treatment-emergent worsening Division of AIDS (Acquired Immunodeficiency Syndrome) (DAIDs) graded laboratory tests. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
The safety population, which was defined as all participants randomized and treated with at least one dose of ACH-0141625 or Placebo. Participants were analyzed according to the randomized treatment.
Posted
Number
percentage of participants
4 weeks
ID
Title
Description
OG000
Segment 1: Placebo
Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
Placebo: Powder in capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
OG001
Segment 1: 200 mg ACH-0141625
200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
OG002
Segment 1: 400 mg ACH-0141625
400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
OG003
Segment 1: 800 mg ACH-0141625
800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
Units
Counts
Participants
OG00015
OG00116
OG00216
OG003
Title
Denominators
Categories
Adverse Events (%)
Title
Measurements
OG00093.3
OG001100.0
OG00293.8
OG003
Primary
Segment 1: Rapid Viral Response At Week 4 (RVR4)
The primary efficacy endpoint for Segment 1 of the study was the percentage of participants in each treatment group achieving RVR4 (hepatitis C virus [HCV] ribonucleic acid (RNA) less than or equal to the limit of quantitation [LOQ] at the Week 4 visit).
Efficacy analysis was performed on the virology population (a subset of the ITT population) and included all participants who had a baseline HCV RNA result and at least 1 post-baseline HCV RNA result.
Posted
Number
percentage of participants
4 weeks
ID
Title
Description
OG000
Segment 1: Placebo
Placebo for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
Placebo: Powder in capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
OG001
Segment 1: 200 mg ACH-0141625
200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and RBV for 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
OG002
Segment 1: 400 mg ACH-0141625
400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
Primary
Segment 2: Safety
Segment 2: Percentage of participants with the following: adverse events, abnormal laboratory safety tests and dose reductions, interruptions and discontinuations. Criteria for abnormal laboratory safety tests: treatment-emergent worsening DAIDs graded laboratory tests. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
The safety population, which was defined as all participants randomized and treated with at least 1 dose of ACH-0141625. Participants were analyzed according to the randomized treatment.
Posted
Number
percentage of participants
12 weeks
ID
Title
Description
OG000
Segment 2: 200 mg ACH-0141625
200 mg ACH-0141625 for 12 weeks plus Peg-IFN alpha-2a and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
OG001
Segment 2: 400 mg ACH-0141625
400 mg ACH-0141625 for 12 weeks plus Peg-IFN alpha-2a plus RBV for up to 24 or 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
OG002
Primary
Segment 2: Complete Early Virologic Response (cEVR)
The primary efficacy endpoint for Segment 2 of the study was the percentage of participants achieving cEVR, defined as undetectable HCV RNA at Week 12.
Per protocol virology population (a subset of the virology population) and included all randomized participants who completed 12 weeks of ACH-0141625 dosing.
Posted
Number
percentage of participants
Week 12
ID
Title
Description
OG000
Segment 2: 200 mg ACH-0141625
200 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
OG001
Segment 2: 400 mg ACH-0141625
400 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
OG002
Segment 2: 800 mg ACH-0141625
800 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 800 mg oral capsule once daily for 28 days
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
Secondary
Segment 1: cEVR
For Segment 1, the percentage of participants in the virology population who achieved cEVR, defined as undetectable HCV RNA at Week 12.
Analysis for Segment 1 was performed on the virology population (the same as the ITT population) and included all participants who had a baseline HCV RNA result and at least 1 post-baseline HCV RNA result.
Posted
Number
percentage of participants
12 weeks
ID
Title
Description
OG000
Segment 1: 200 mg ACH-0141625
200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and RBV for 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
OG001
Segment 1: 400 mg ACH-0141625
400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
OG002
Segment 1: 800 mg ACH-0141625
800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
Secondary
Segment 2: RVR4
For Segment 2, the percentage of participants in the virology population who achieved RVR4, defined as HCV RNA less than or equal to the LOQ at the Week 4 visit.
Per protocol virology population (a subset of the virology population) and included all randomized participants who completed 4 weeks of ACH-0141625 dosing.
Posted
Number
percentage of participants
4 weeks
ID
Title
Description
OG000
Segment 2: 200 mg ACH-0141625
200 mg ACH-0141625 for 12 weeks plus Peg-IFN alpha-2a and RBV for 48 weeks
ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
OG001
Segment 2: 400 mg ACH-0141625
400 mg ACH-0141625 for 12 weeks plus Peg-IFN alpha-2a plus RBV for 48 weeks
ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
OG002
Segment 2: 800 mg ACH-0141625
800 mg ACH-0141625 for 12 weeks plus Peg-IFN alpha-2a plus RBV for 48 weeks
ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
Secondary
Segment 1 And Segment 2: End Of Treatment Response
The percentage of virology population participants who were reported as undetectable HCV RNA at the completion of treatment.
Segment 2 analyzed the per protocol population (PPP), which includes all randomized participants who completed 12 weeks of ACH-0141625 dosing and an additional 12 weeks of Peg/RBV dosing.
Posted
Number
percentage of participants
Week 48 (Segment 1); Week 24 (Segment 2)
ID
Title
Description
OG000
Segment 1: 200 mg ACH-0141625
200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and RBV for 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
OG001
Segment 1: 400 mg ACH-0141625
400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
OG002
Segment 1: 800 mg ACH-0141625
800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
The percentage of virology population participants who achieved sustained virologic response (SVR), defined as HCV RNA less than the LOQ, at 12 weeks (3 months) post-dosing.
Segment 2 analyzed the PPP (all randomized participants completing 12 weeks of ACH-0141625 + an extra 12 weeks of Peg/RBV) who returned for SVR12.
Posted
Number
percentage of participants
3 months post-dosing
ID
Title
Description
OG000
Segment 1: 200 mg ACH-0141625
200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and RBV for 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
OG001
Segment 1: 400 mg ACH-0141625
400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV
ACH-0141625: 400 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
OG002
Segment 1: 800 mg ACH-0141625
800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
The percentage of virology population participants who achieved SVR, defined as HCV RNA less than the LOQ, 6 months post-dosing.
Segment 2 analyzed the PPP (all randomized participants completing 12 weeks of ACH-0141625 plus an extra 12 weeks of Peg/RBV) who returned for SVR24
Posted
Number
percentage of participants
6 months post-dosing
ID
Title
Description
OG000
Segment 1: 200 mg ACH-0141625
200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and RBV for 48 weeks
ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
OG001
Segment 1: 400 mg ACH-0141625
400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
OG002
Segment 1: 800 mg ACH-0141625
Secondary
Segment 1 And Segment 2: HCV RNA Change From Baseline
The mean change from baseline in log10 HCV RNA level by visit for the virology population
Efficacy analysis was performed on the virology population, which was a subset of the ITT population and included all participants who had a baseline HCV RNA result and at least 1 post-baseline HCV RNA result.
Posted
Mean
Standard Deviation
log10 HCV RNA Level
Week 4
ID
Title
Description
OG000
Segment 1: 200 mg ACH-0141625
200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and RBV for 48 weeks
ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
OG001
Segment 1: 400 mg ACH-0141625
400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
OG002
Segment 1: 800 mg ACH-0141625
800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
Secondary
Segment 1 And Segment 2: HCV RNA Change From Baseline
Change from baseline in log10 HCV RNA level by visit.
Efficacy analysis was performed on the virology population, a subset of the ITT population, and included all participants who had a baseline HCV RNA result and at least 1 post-baseline HCV RNA result.
Posted
Mean
Standard Deviation
log10 HCV RNA level
Week 12
ID
Title
Description
OG000
Segment 1: 200 mg ACH-0141625
200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and RBV for 48 weeks
ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
OG001
Segment 1: 400 mg ACH-0141625
400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
OG002
Segment 1: 800 mg ACH-0141625
800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
Time Frame
Adverse event data collected through end of treatment plus 4 weeks.
Description
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Segment 1: 200 mg ACH-0141625
200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and RBV for 48 weeks
ACH-0141625: 200 mg oral capsule
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
2
16
16
16
EG001
Segment 1: 400 mg ACH-0141625
400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Peg-IFN Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
1
16
15
16
EG002
Segment 1: 800 mg ACH-0141625
800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
5
17
17
17
EG003
Segment 2: 200 mg ACH-0141625
200 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
0
19
18
19
EG004
Segment 2: 400 mg ACH-0141625
400 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
2
20
17
20
EG005
Segment 2: 800 mg ACH-0141625
800 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
0
19
19
19
EG006
Segment 1: Placebo
Placebo for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
Placebo: Powder in capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
0
15
14
15
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Ischemic Colitis
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected17 at risk
EG0030 events0 affected19 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected15 at risk
Bacteremia
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected17 at risk
EG003
Chest Pain
General disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected17 at risk
EG003
Mania
Psychiatric disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected17 at risk
EG003
Syncope
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected17 at risk
EG003
Severe Coronary Atherosclerosis MI (death)
Cardiac disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected17 at risk
EG003
Exacerbation of schizophrenia
Psychiatric disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected17 at risk
EG003
Left Lower Extremity Deep Vein Thrombosis
Vascular disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected17 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected17 at risk
EG003
Depression
Psychiatric disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected17 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0014 affected16 at risk
EG0023 affected17 at risk
EG0032 affected19 at risk
EG0041 affected20 at risk
EG0052 affected19 at risk
EG0063 affected15 at risk
Haemoglobinaemia
Blood and lymphatic system disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Haemolytic anaemia
Blood and lymphatic system disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0012 affected16 at risk
EG0021 affected17 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected16 at risk
EG0012 affected16 at risk
EG0023 affected17 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0021 affected17 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected16 at risk
EG0011 affected16 at risk
EG0020 affected17 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected16 at risk
EG0020 affected17 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0021 affected17 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Thyroid disorder
Endocrine disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Abnormal sensation in eye
Eye disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Dry eye
Eye disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0021 affected17 at risk
EG003
Eye irritation
Eye disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0021 affected17 at risk
EG003
Eye pain
Eye disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0021 affected17 at risk
EG003
Eye pruritus
Eye disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Photophobia
Eye disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Vision blurred
Eye disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0012 affected16 at risk
EG0021 affected17 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected16 at risk
EG0012 affected16 at risk
EG0022 affected17 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0002 affected16 at risk
EG0012 affected16 at risk
EG0021 affected17 at risk
EG003
Abdominal tenderness
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Anal fissure
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Aphthous stomatitis
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0022 affected17 at risk
EG003
Breath odour
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0021 affected17 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0005 affected16 at risk
EG0013 affected16 at risk
EG0024 affected17 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0002 affected16 at risk
EG0012 affected16 at risk
EG0020 affected17 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0003 affected16 at risk
EG0011 affected16 at risk
EG0021 affected17 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Gingivitis
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0021 affected17 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Lip ulceration
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0005 affected16 at risk
EG0015 affected16 at risk
EG0028 affected17 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected16 at risk
EG0012 affected16 at risk
EG0022 affected17 at risk
EG003
Application site erythema
General disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected16 at risk
EG0020 affected17 at risk
EG003
Asthenia
General disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected16 at risk
EG0020 affected17 at risk
EG003
Chest pain
General disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected16 at risk
EG0020 affected17 at risk
EG003
Chills
General disorders
MedDRA 12.1
Systematic Assessment
EG0002 affected16 at risk
EG0012 affected16 at risk
EG0023 affected17 at risk
EG003
Fatigue
General disorders
MedDRA 12.1
Systematic Assessment
EG0005 affected16 at risk
EG0017 affected16 at risk
EG0027 affected17 at risk
EG003
Influenza like illness
General disorders
MedDRA 12.1
Systematic Assessment
EG0006 affected16 at risk
EG0012 affected16 at risk
EG0025 affected17 at risk
EG003
Injection site erythema
General disorders
MedDRA 12.1
Systematic Assessment
EG0002 affected16 at risk
EG0012 affected16 at risk
EG0024 affected17 at risk
EG003
Injection site haematoma
General disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0021 affected17 at risk
EG003
Injection site irritation
General disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Injection site pain
General disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Injection site pruritus
General disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Injection site rash
General disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Injection site reaction
General disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Irritability
General disorders
MedDRA 12.1
Systematic Assessment
EG0003 affected16 at risk
EG0013 affected16 at risk
EG0022 affected17 at risk
EG003
Pain
General disorders
MedDRA 12.1
Systematic Assessment
EG0003 affected16 at risk
EG0013 affected16 at risk
EG0024 affected17 at risk
EG003
Pyrexia
General disorders
MedDRA 12.1
Systematic Assessment
EG0004 affected16 at risk
EG0013 affected16 at risk
EG0020 affected17 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0021 affected17 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected16 at risk
EG0021 affected17 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0021 affected17 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0021 affected17 at risk
EG003
Herpes virus infection
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Impetigo
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0021 affected17 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected16 at risk
EG0020 affected17 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected16 at risk
EG0021 affected17 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0022 affected17 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Animal scratch
Injury, poisoning and procedural complications
MedDRA 12.1
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Gun shot wound
Injury, poisoning and procedural complications
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 12.1
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 12.1
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 12.1
Systematic Assessment
Grade 3 ALT elevation occurred about Week 10. ACH-0141625 was held for 4 days, during which ALT decreased. Participant was re-challenged with ACH-0141625 for the remaining week of therapy; ALT levels continued to improve, normalizing by Week 16.
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0021 affected17 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Creatinine renal clearance decreased
Investigations
MedDRA 12.1
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 12.1
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Transaminases increased
Investigations
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected16 at risk
EG0013 affected16 at risk
EG0022 affected17 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected16 at risk
EG0021 affected17 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Insulin resistance
Metabolism and nutrition disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Polydipsia
Metabolism and nutrition disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected16 at risk
EG0020 affected17 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG0004 affected16 at risk
EG0010 affected16 at risk
EG0022 affected17 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected16 at risk
EG0021 affected17 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Muscle fatigue
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected16 at risk
EG0021 affected17 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG0004 affected16 at risk
EG0011 affected16 at risk
EG0021 affected17 at risk
EG003
Neck mass
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0021 affected17 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0021 affected17 at risk
EG003
Periarthritis
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected16 at risk
EG0020 affected17 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0002 affected16 at risk
EG0011 affected16 at risk
EG0022 affected17 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0012 affected16 at risk
EG0022 affected17 at risk
EG003
Dizziness postural
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected16 at risk
EG0020 affected17 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0003 affected16 at risk
EG0012 affected16 at risk
EG0020 affected17 at risk
EG003
Headache
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0008 affected16 at risk
EG0017 affected16 at risk
EG0025 affected17 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Mental impairment
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Migraine
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Poor quality sleep
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected16 at risk
EG0020 affected17 at risk
EG003
Syncope
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Abnormal dreams
Psychiatric disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected16 at risk
EG0020 affected17 at risk
EG003
Affect lability
Psychiatric disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected16 at risk
EG0023 affected17 at risk
EG003
Alcohol abuse
Psychiatric disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected16 at risk
EG0021 affected17 at risk
EG003
Delusion
Psychiatric disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0021 affected17 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected16 at risk
EG0020 affected17 at risk
EG003
Depression
Psychiatric disorders
MedDRA 12.1
Systematic Assessment
EG0002 affected16 at risk
EG0012 affected16 at risk
EG0022 affected17 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0021 affected17 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 12.1
Systematic Assessment
EG0004 affected16 at risk
EG0011 affected16 at risk
EG0022 affected17 at risk
EG003
Libido decreased
Psychiatric disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected16 at risk
EG0021 affected17 at risk
EG003
Mania
Psychiatric disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Mood swings
Psychiatric disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Nervousness
Psychiatric disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Sleep terror
Psychiatric disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Tearfulness
Psychiatric disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Polyuria
Renal and urinary disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected16 at risk
EG0020 affected17 at risk
EG003
Renal failure chronic
Renal and urinary disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0021 affected17 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0013 affected16 at risk
EG0020 affected17 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected16 at risk
EG0011 affected16 at risk
EG0020 affected17 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected16 at risk
EG0011 affected16 at risk
EG0021 affected17 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0021 affected17 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected16 at risk
EG0020 affected17 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected16 at risk
EG0020 affected17 at risk
EG003
Upper respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0021 affected17 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected16 at risk
EG0023 affected17 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected16 at risk
EG0020 affected17 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected16 at risk
EG0011 affected16 at risk
EG0021 affected17 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected16 at risk
EG0021 affected17 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected16 at risk
EG0011 affected16 at risk
EG0021 affected17 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected16 at risk
EG0012 affected16 at risk
EG0020 affected17 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0021 affected17 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected17 at risk
EG003
Skin chapped
Skin and subcutaneous tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0021 affected17 at risk
EG003
Hot flush
Vascular disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected16 at risk
EG0020 affected17 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Prior to submitting/presenting a manuscript or materials relating to a Study to a publisher, reviewer, or outside person, the Institution shall provide to Sponsor a copy of all such manuscripts or materials, and Sponsor shall have sixty (60) days to review and comment. The Institution shall, upon Sponsor's request, further delay publication or presentation for a period of up to one hundred twenty (120) days to allow Sponsor to protect its interests in any Sponsor Inventions.
Point of Contact
Title
Organization
Phone
Extension
Email
Alexion Pharmaceuticals Inc.
Alexion Pharmaceuticals Inc.
855-752-2356
clinicaltrials@alexion.com
ID
Term
D006526
Hepatitis C
Ancestor Terms
ID
Term
D000086982
Blood-Borne Infections
D003141
Communicable Diseases
D007239
Infections
D006525
Hepatitis, Viral, Human
D014777
Virus Diseases
D018178
Flaviviridae Infections
D012327
RNA Virus Infections
D006505
Hepatitis
D008107
Liver Diseases
D004066
Digestive System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C100416
peginterferon alfa-2a
C417083
peginterferon alfa-2b
D012254
Ribavirin
Ancestor Terms
ID
Term
D012263
Ribonucleosides
D009705
Nucleosides
D009706
Nucleic Acids, Nucleotides, and Nucleosides
Browse Leaves
Not provided
Browse Branches
Not provided
2 subjects
FG0051 subjects
FG0060 subjects
1 subjects
FG0050 subjects
FG0061 subjects
0 subjects
FG0050 subjects
FG0060 subjects
1 subjects
FG0053 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0
BG0040
BG0050
BG0060
BG0070
Between 18 and 65 years
BG00015
BG00116
BG00216
BG00315
BG00419
BG00519
BG00619
BG007119
>=65 years
BG0001
BG0010
BG0021
BG0030
BG0040
BG0051
BG0060
BG0073
52
± 13
BG00347± 9
BG00445± 11
BG00548± 12
BG00642± 12
BG00748± 11
4
BG0034
BG0047
BG0055
BG0069
BG00738
Male
BG00013
BG00110
BG00213
BG00311
BG00412
BG00515
BG00610
BG00784
17
100.0
Abnormal Laboratories (%)
Title
Measurements
OG000100.0
OG001100.0
OG002100.0
OG00394.0
Dose Reductions (%)
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Dose Interruptions (%)
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Dose Discontinuations (%)
Title
Measurements
OG0000
OG0016.0
OG0020
OG0036.0
OG003
Segment 1: 800 mg ACH-0141625
800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
Units
Counts
Participants
OG00015
OG00116
OG00216
OG00317
Title
Denominators
Categories
Rapid Virologic Response (%)
Title
Measurements
OG00020.0
OG00175.0
OG00275.0
OG00376.5
No Rapid Virologic Response (%)
Title
Measurements
OG00080.0
OG00125.0
OG00225.0
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
The null hypothesis is no difference between proportions of participants in each treatment group achieving RVR4 at Week 4 of the study, while the alternative hypothesis is that the proportion of participants achieving RVR4 at Week 4 increases with increasing doses of ACH-0141625.
exact Cochran-Armitage test
Only if overall test for trend is significant are pairwise comparisons evaluated using p-values for the difference in proportions (placebo - active).
0.003
To control for multiplicity, the proportion in each treatment group achieving RVR4 is analyzed using a Cochran-Armitage test for trend among the ordered groups: placebo (considered zero dose), 200 mg, 400 mg, and 800 mg ACH-0141625.
Superiority or Other (legacy)
OG000
OG001
To control for multiplicity, the proportion in each treatment group achieving RVR4 is analyzed using a Cochran-Armitage test for trend among the ordered groups: placebo (considered zero dose), 200 mg ACH-0141625, 400 mg ACH-0141625, and 800 mg ACH-0141625. Only if overall test for trend is significant are pairwise comparisons evaluated using p-values for the difference in proportions (placebo - active).
Fisher Exact
0.004
Superiority or Other (legacy)
OG000
OG002
To control for multiplicity, the proportion in each treatment group achieving RVR4 is analyzed using a Cochran-Armitage test for trend among the ordered groups: placebo (considered zero dose), 200 mg ACH-0141625, 400 mg ACH-0141625, and 800 mg ACH-0141625. Only if overall test for trend is significant are pairwise comparisons evaluated using p-values for the difference in proportions (placebo - active).
Fisher Exact
0.004
Superiority or Other (legacy)
OG000
OG003
To control for multiplicity, the proportion in each treatment group achieving RVR4 is analyzed using a Cochran-Armitage test for trend among the ordered groups: placebo (considered zero dose), 200 mg ACH-0141625, 400 mg ACH-0141625, and 800 mg ACH-0141625. Only if overall test for trend is significant are pairwise comparisons evaluated using p-values for the difference in proportions (placebo - active).
Fisher Exact
0.004
Superiority or Other (legacy)
Segment 2: 800 mg ACH-0141625
800 mg ACH-0141625 for 12 weeks plus Peg-IFN alpha-2a plus RBV for up to 24 or 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
Units
Counts
Participants
OG00019
OG00120
OG00219
Title
Denominators
Categories
Adverse Events (%)
Title
Measurements
OG00094.7
OG00185.0
OG002100.0
Abnormal Laboratories (%)
Title
Measurements
OG000100.0
OG00195.0
OG002100.0
Dose Reductions (%)
Title
Measurements
OG0000
OG0010
OG0020
Dose Interruptions (%)
Title
Measurements
OG0000
OG0010
OG0020
Dose Discontinuations (%)
Title
Measurements
OG0006.0
OG00120.0
OG0020
Units
Counts
Participants
OG00018
OG00116
OG00219
Title
Denominators
Categories
Title
Measurements
OG000100.0
OG00194.0
OG002100.00
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
The null hypothesis is no difference between proportions of participants in each treatment group achieving cEVR at Week 12 of the study, while the alternative hypothesis is that the proportion of participants achieving cEVR at Week 12 increases with increasing doses of ACH-0141625.
Exact Cochran-Armitage test
Only if overall test for trend is significant are pairwise comparisons evaluated using p-values for the difference in proportions (placebo - active).
0.34
To control for multiplicity, the proportion of participants in each treatment group achieving cEVR is analyzed using a Cochran-Armitage test for trend among the ordered treatment groups: 200 mg ACH-0141625, 400 mg ACH-0141625, and 800 mg ACH-0141625.
Superiority or Other (legacy)
OG003
Segment 1: Placebo
Placebo for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
Placebo: powder in capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
Units
Counts
Participants
OG00016
OG00116
OG00217
OG00315
Title
Denominators
Categories
Title
Measurements
OG00062.5
OG00175.0
OG00270.6
OG00333.3
Units
Counts
Participants
OG00019
OG00118
OG00219
Title
Denominators
Categories
Title
Measurements
OG00078.9
OG00188.8
OG00289.5
OG003
Segment 1: Placebo
Placebo for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
Placebo: Powder in capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
OG004
Segment 2: 200 mg ACH-0141625
200 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
OG005
Segment 2: 400 mg ACH-0141625
400 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
OG006
Segment 2: 800 mg ACH-0141625
800 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
Units
Counts
Participants
OG00016
OG00116
OG00217
OG00315
OG00412
OG00513
OG00614
Title
Denominators
Categories
Title
Measurements
OG00075.0
OG00175.0
OG00264.7
OG00353.3
OG004100.0
OG00592.3
OG006100.0
OG003
Segment 1: Placebo
Placebo for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
Placebo: Powder in capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
OG004
Segment 2: 200 mg ACH-0141625
200 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 200 mg oral capsule once daily for
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
OG005
Segment 2: 400 mg ACH-0141625
400 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
OG006
Segment 2: 800 mg ACH-0141625
800 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Peg-IFN Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
Units
Counts
Participants
OG00016
OG00116
OG00217
OG00315
OG00410
OG00513
OG00613
Title
Denominators
Categories
Title
Measurements
OG00056.3
OG00156.3
OG00235.3
OG00340.0
OG00480.0
OG00576.9
OG00684.5
800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
OG003
Segment 1: Placebo
Placebo for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
Placebo: Powder in capsule once daily for 28 days
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
OG004
Segment 2: 200 mg ACH-0141625
200 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 48 weeks
ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
OG005
Segment 2: 400 mg ACH-0141625
400 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 48 weeks
ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
OG006
Segment 2 : 800 mg ACH-0141625
800 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 48 weeks
ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
Units
Counts
Participants
OG00016
OG00116
OG00217
OG00315
OG00410
OG00513
OG00612
Title
Denominators
Categories
Title
Measurements
OG00062.5
OG00156.3
OG00235.3
OG00340.0
OG00470.0
OG00576.9
OG00683.3
OG003
Segment 1: Placebo
Placebo for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
Placebo: Powder in capsule once daily for 28 days
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
OG004
Segment 2: 200 mg ACH-0141625
200 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 48 weeks
ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
OG005
Segment 2: 400 mg ACH-0141625
400 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 48 weeks
ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
OG006
Segment 2: 800 mg ACH-0141625
800 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 48 weeks
ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
Units
Counts
Participants
OG00013
OG00115
OG00216
OG00315
OG00419
OG00518
OG00619
Title
Denominators
Categories
Title
Measurements
OG000-4.94± 0.993
OG001-4.60± 1.462
OG002-4.94± 1.098
OG003-2.22± 1.447
OG004-4.74± 1.072
OG005-5.04± 0.738
OG006-4.51± 0.941
OG003
Segment 1: Placebo
Placebo for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
Placebo: Powder in capsule once daily for 28 days
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
OG004
Segment 2: 200 mg ACH-0141625
200 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 48 weeks
ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
OG005
Segment 2: 400 mg ACH-0141625
400 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 48 weeks
ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
OG006
Segment 2: 800 mg ACH-0141625
800 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 48 weeks
ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks