Safety, Antiviral Effect and PK of BI 207127 + BI 201335... | NCT01132313 | Trialant
NCT01132313
Sponsor
Boehringer Ingelheim
Status
Completed
Last Update Posted
Feb 1, 2016Estimated
Enrollment
488Actual
Phase
Phase 2
Conditions
Hepatitis C, Chronic
Interventions
BI 207127
BI 201335
BI 207127
BI 201335
Ribavirin
Ribavirin
Ribavirin
BI 207127
BI 207127
BI 207127
BI 201335
Ribavirin
Ribavirin
BI 207127
BI 207127
BI 201335
BI 201335
Ribavirin
BI 201335
BI 201335
BI 207127
BI 201335
BI 201335
BI 207127
BI 201335
Ribavirin
Ribavirin
BI 207217
BI 201335
BI 207127
Ribavirin
BI 207127
BI 201335
Ribavirin
Ribavirin
Countries
United States
Australia
Austria
France
Germany
New Zealand
Portugal
Romania
Spain
Switzerland
Protocol Section
Identification Module
NCT ID
NCT01132313
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
1241.21
Secondary IDs
ID
Type
Description
Link
2009-018197-66
EudraCT Number
EudraCT
Brief Title
Safety, Antiviral Effect and PK of BI 207127 + BI 201335 +/- RBV for 4 up to 40 Weeks in Patients With Chronic HCV Genotype 1 Infection
Official Title
Safety, Antiviral Effect and Pharmacokinetics of BI 207127 in Combination With BI 201335 and With or Without Ribavirin for 4, 16, 24, 28 or 40 Weeks in Patients With Chronic HCV Genotype 1 Infection (Randomized Phase Ib/II)
Acronym
Not provided
Organization
Boehringer IngelheimINDUSTRY
Status Module
Record Verification Date
Dec 2015
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
May 2010
Primary Completion Date
Oct 2014Actual
Completion Date
Oct 2014Actual
First Submitted Date
May 3, 2010
First Submission Date that Met QC Criteria
May 26, 2010
First Posted Date
May 28, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 29, 2015
Results First Submitted that Met QC Criteria
Dec 22, 2015
Results First Posted Date
Feb 1, 2016Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Nov 5, 2014
Certification/Extension First Submitted that Passed QC Review
Nov 5, 2014
Certification/Extension First Posted Date
Nov 18, 2014Estimated
Last Update Submitted Date
Dec 22, 2015
Last Update Posted Date
Feb 1, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Boehringer IngelheimINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
The substances BI 201335 and BI 207127 are being developed for the treatment of chronic hepatitis C virus infection. BI 201335 and BI 207127 work by preventing the virus from replicating.
The currently available medications pegylated interferon alfa and ribavirin for hepatitis C ca have considerable adverse events in patients and in many cases are not sufficiently effective. This is particularly the case in treatment of patients infected with genotype 1 of HCV.
A combination therapy of these new substances without pegylated interferon alfa may be associated with fewer adverse events that currently available (pegylated interferon-alfa-based) medication and may also provide a treatment option to the large number of patients with contraindications or intolerance to pegylated interferon alfa.
This clinical trial (1241.21) currently consists of 3 distinct studies: Part 1, Part 2 and Part 3.
Part 1 (SOUND-C1) is a 2 armed study as described in experimental arms 1 and 2 below (actual enrollment: 56 patients; randomized and treated: 32) Part 2 (SOUND-C2) is a 5 armed study as described in experimental arms 3 to 7 below (actual enrollment: 465; randomized and treated: 362) Part 3 (SOUND-C3) includes 3 arms as described in experimental arms 8 to 10 below (83 patients randomized and treated)
Detailed Description
Not provided
Conditions Module
Conditions
Hepatitis C, Chronic
Keywords
Not provided
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
488Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
2
Experimental
4 weeks of high dose TID BI 207127 and QD BI 201335 in combination with RBV, Part 1
Drug: Ribavirin
Drug: BI 201335
Drug: BI 207127
1
Experimental
4 weeks of low dose three times per day (TID) BI 207127 and once daily (QD) BI 201335 in combination with RBV, Part 1
Drug: BI 207127
Drug: BI 201335
Drug: Ribavirin
3
Experimental
16 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2
Drug: BI 207127
Drug: BI 201335
Drug: Ribavirin
4
Experimental
28 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2
Drug: BI 207127
Drug: Ribavirin
Drug: BI 201335
5
Experimental
40 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2
Drug: BI 201335
Drug: BI 207127
Drug: Ribavirin
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BI 207127
Drug
28 weeks, high dose, TID
4
BI 201335
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 1: Rapid Virological Response (RVR)
Part 1: Rapid virological response (RVR), defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) <25IU/mL at Week 4 of treatment
4 weeks
Part 2: Sustained Virological Response (SVR)
Part 2: Sustained virological response (SVR), defined as HCV RNA <25 IU/mL and undetectable at 12 weeks after end of treatment
From drug administration until 12 weeks after end of treatment, up to 52 weeks
Part 3 and 4: Sustained Virological Response (SVR)
Part 3 and 4: Sustained virological response (SVR) defined as HCV RNA <25IU/mL and undetectable at 12 weeks after end of treatment
From drug administration until 12 weeks after end of treatment, up to 36 weeks
Secondary Outcomes
Measure
Description
Time Frame
Part 1: Time to Virological Response
Part 1: Time to virological response, defined as the timepoint of the first measurement of plasma HCV RNA level <25 IU/mL. The percentage of participants who achieved virological response within each time period are displayed for this outcome measure.
From drug administration until end of drug administration, up to 4 weeks
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
Chronic hepatitis C virus (HCV) infection of genotype (GT) 1
Parts 1-3:Treatment naive to Interferon -alfa (IFN), Pegylated interferon -alfa (PegIFN), ribavirin (RBV), and any direct acting antiviral agent for chronic hepatitis C
Part 4: Treatment experienced with confirmed prior virological failure to an approved dose of PegIFN/RBV (null-response)
HCV RNA >=10,000 IU/mL at screening
Liver biopsy within two years or fibroscan within six months prior to baseline
Liver biopsy within two years or fibroscan within 6 months prior to screening
Age 18-75 years
Exclusion criteria:
Hepatitis C virus (HCV) infection of mixed genotype
Evidence of liver disease due to causes other than chronic HCV infection
Positive ELISA for human immunodeficiency virus (HIV)
Hepatitis B virus (HBV) infection
Decompensated liver disease or history of decompensated liver disease
Active or suspected malignancy within the last 5 years
Ongoing or historical photosensitivity or recurrent rash
History of alcohol or drug abuse (except cannabis) within the past 12 months
Body mass index (BMI)I <18 or > 35 kg/m2
Usage of any investigational drugs within 30 days prior to enrolment, or 5 half-lives, whichever is longer; o the planned usage of an investigational drug during the course of the current study
Known hypersensitivity to any ingredient of the study drugs
A condition that is defined as one which in the opinion of the investigator may interfere with the patient's capability for participation in the trial or may influence the results of the trial
Alpha fetoprotein >100ng/mL at screening; if >20ng/mL and <=100ng/mL, patients can be included if there is no evidence of liver cancer in an appropriate imaging study within 6 months prior to randomisation
Total bilirubin > 2 mg/dL with ratio of direct/indirect > 1
AST or ALT >5xULN
INR prolonged to >1.7xULN
Requirement for chronic systemic corticosteroids
Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to enrolment or 5 half-lives, whichever is longer
Received silymarin or glycyrrhizin or Sho-saiko-to within 30 days prior to enrolment
Contraindications pertaining to PegIFN or RBV
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
75 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Boehringer Ingelheim
Boehringer Ingelheim
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
1241.21.0003 Boehringer Ingelheim Investigational Site
La Jolla
California
United States
1241.21.0006 Boehringer Ingelheim Investigational Site
This trial was conducted in 4 parts, each consisting of randomised, open-label treatments.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1: 400mg DBV and 120mg FDV - 4w
Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)
FG001
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
5
More Info Module
Limitations and Caveats
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
Not provided
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
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
6
Experimental
28 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 2
Drug: Ribavirin
Drug: BI 201335
Drug: BI 207217
7
Experimental
28 weeks of TID BI 207127 and QD BI 201335 without RBV, Part 2
Drug: BI 207127
Drug: BI 201335
8
Experimental
16 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 3
Drug: BI 207127
Drug: Ribavirin
Drug: BI 201335
9
Experimental
24 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 3
Drug: BI 207127
Drug: BI 201335
Drug: Ribavirin
10
Experimental
24 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 3
Drug: BI 201335
Drug: BI 207127
Drug: Ribavirin
11
Experimental
16 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 4
Drug: Ribavirin
Drug: BI 207127
Drug: BI 201335
12
Experimental
24 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 4
Drug: Ribavirin
Drug: BI 201335
Drug: BI 207127
Drug
40 weeks, QD
5
BI 207127
Drug
4 weeks, low dose TID
1
BI 201335
Drug
24 weeks, QD
1
Ribavirin
Drug
16 weeks, according to label
11
Ribavirin
Drug
28 weeks, according to label
4
Ribavirin
Drug
28 weeks, according to label
6
BI 207127
Drug
40 weeks, high dose, TID
5
BI 207127
Drug
24 weeks, very high dose, BID
9
BI 207127
Drug
16 weeks, standard dose, BID
11
BI 201335
Drug
24 weeks, QD
10
Ribavirin
Drug
48 weeks, according to label
2
Ribavirin
Drug
40 weeks, according to label
5
BI 207127
Drug
16 weeks, high dose, TID
3
BI 207127
Drug
28 weeks, high dose, TID
7
BI 201335
Drug
28 weeks, QD
6
BI 201335
Drug
16 weeks, QD
11
Ribavirin
Drug
24 weeks, according to label
12
BI 201335
Drug
24 weeks, QD
12
BI 201335
Drug
28 weeks, QD
7
BI 207127
Drug
24 weeks, standard dose, BID
12
BI 201335
Drug
24 weeks, QD
9
BI 201335
Drug
16 weeks, QD
3
BI 207127
Drug
16 weeks, high dose, BID
8
BI 201335
Drug
24 weeks, QD
2
Ribavirin
Drug
16 weeks, according to label
3
Ribavirin
Drug
16 weeks, according to label
8
BI 207217
Drug
28 weeks, high dose BID
6
BI 201335
Drug
16 weeks, QD
8
BI 207127
Drug
24 weeks, high dose, TID
10
Ribavirin
Drug
48 weeks, according to label
1
BI 207127
Drug
4 weeks, high dose, TID
2
BI 201335
Drug
28 weeks, QD
4
Ribavirin
Drug
24 weeks, according to label
9
Ribavirin
Drug
24 weeks, according to label
10
Part 2: Time to Virological Response
Part 2: Time to virological response, defined as the timepoint of the first measurement of plasma HCV RNA level <25 IU/mL. The percentage of participants who achieved virological response within each time period are displayed for this outcome measure.
From drug administration until end of drug administration, up to 40 weeks
Part 1 and 2: Plasma HCV RNA Level Not Detectable at Week 4
Part 1 and 2: Plasma Hepatitis C Virus Ribonucleic acid (HCV RNA) level not detectable at Week 4
4 weeks
Part 2: Sustained Virological Response at 4 and 24 Weeks After End of Treatment
Part 2: Sustained virological response at 4 and 24 weeks after end of treatment
4 weeks and 24 weeks after the end of treatment, up to 64 weeks
Part 3 and 4: Plasma HCV RNA Level <25 IU/mL at Week 4 and 12 of Treatment
Part 3 and 4: Plasma Hepatitis C Virus Ribonucleic acid (HCV RNA) level <25 IU/mL at week 4 and 12 of treatment
Week 4 and 12
Part 3 and 4: Sustained Virological Response (SVR) at 4 Weeks After End of Treatment
Part 3 and 4: Sustained virological response (SVR) at 4 weeks after end of treatment
up to 28 weeks
San Diego
California
United States
1241.21.0004 Boehringer Ingelheim Investigational Site
San Francisco
California
United States
1241.21.0011 Boehringer Ingelheim Investigational Site
Palm Harbor
Florida
United States
1241.21.0013 Boehringer Ingelheim Investigational Site
Valparaiso
Indiana
United States
1241.21.0008 Boehringer Ingelheim Investigational Site
Springfield
Massachusetts
United States
1241.21.0019 Boehringer Ingelheim Investigational Site
Fayetteville
North Carolina
United States
1241.21.0012 Boehringer Ingelheim Investigational Site
Arlington
Texas
United States
1241.21.0005 Boehringer Ingelheim Investigational Site
Austin
Texas
United States
1241.21.0007 Boehringer Ingelheim Investigational Site
Dallas
Texas
United States
1241.21.0010 Boehringer Ingelheim Investigational Site
Houston
Texas
United States
1241.21.0017 Boehringer Ingelheim Investigational Site
Seattle
Washington
United States
1241.21.61002 Boehringer Ingelheim Investigational Site
Heidelberg
Victoria
Australia
1241.21.61001 Boehringer Ingelheim Investigational Site
Melbourne
Victoria
Australia
1241.21.43003 Boehringer Ingelheim Investigational Site
Linz
Austria
1241.21.43001 Boehringer Ingelheim Investigational Site
Vienna
Austria
1241.21.43002 Boehringer Ingelheim Investigational Site
Vienna
Austria
1241.21.33005 Boehringer Ingelheim Investigational Site
Clichy
France
1241.21.33007 Boehringer Ingelheim Investigational Site
Zeuzem S, Soriano V, Asselah T, Gane EJ, Bronowicki JP, Angus P, Lohse AW, Stickel F, Mullhaupt B, Roberts S, Schuchmann M, Manns M, Bourliere M, Buti M, Stern JO, Gallivan JP, Voss F, Sabo JP, Bocher W, Mensa FJ; SOUND-C2 Study Group. Efficacy and safety of faldaprevir, deleobuvir, and ribavirin in treatment-naive patients with chronic hepatitis C virus infection and advanced liver fibrosis or cirrhosis. Antimicrob Agents Chemother. 2015 Feb;59(2):1282-91. doi: 10.1128/AAC.04383-14. Epub 2014 Dec 15.
Zeuzem S, Asselah T, Angus P, Zarski JP, Larrey D, Mullhaupt B, Gane E, Schuchmann M, Lohse AW, Pol S, Bronowicki JP, Roberts S, Arasteh K, Zoulim F, Heim M, Stern JO, Nehmiz G, Kukolj G, Bocher WO, Mensa FJ. Faldaprevir (BI 201335), deleobuvir (BI 207127) and ribavirin oral therapy for treatment-naive HCV genotype 1: SOUND-C1 final results. Antivir Ther. 2013;18(8):1015-9. doi: 10.3851/IMP2567. Epub 2013 Apr 4.
Part 1: 600mg DBV and 120mg FDV - 4w
Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)
FG002
Part 2: 600mg DBV and 120mg FDV - 16w
Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
FG003
Part 2: 600mg DBV TID and 120mg FDV - 28w
Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
FG004
Part 2: 600mg DBV and 120mg FDV - 40w
Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
FG005
Part 2: 600mg DBV BID and 120mg FDV - 28w
Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
FG006
Part 2: 600mg DBV and 120mg FDV, no RBV - 28w
Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
FG007
Part 3: 600mg DBV and 120mg FDV - 16w
Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
FG008
Part 3: 800mg DBV and 120mg FDV - 24w
Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
FG009
Part 3: 600mg DBV and 120mg FDV - 24w
Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
FG010
Part 4: 600 mg DBV and 120mg FDV - 16w
Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
FG011
Part 4: 600 mg DBV and 120mg FDV - 24w
Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
FG00017 subjects
FG00117 subjects
FG00281 subjects
FG00380 subjects
FG00479 subjects
FG00579 subjects
FG00649 subjects
FG00732 subjects
FG00826 subjects
FG00925 subjects
FG0101 subjects
FG0112 subjects
COMPLETED
FG00014 subjects
FG00117 subjects
FG00261 subjects
FG00348 subjects
FG00434 subjects
FG00554 subjects
FG00619 subjects
FG00724 subjects
FG0085 subjects
FG0095 subjects
FG0100 subjects
FG0112 subjects
NOT COMPLETED
FG0003 subjects
FG0010 subjects
FG00220 subjects
FG00332 subjects
FG00445 subjects
FG00525 subjects
FG00630 subjects
FG0078 subjects
FG00821 subjects
FG00920 subjects
FG0101 subjects
FG0110 subjects
Type
Comment
Reasons
Lack of Efficacy
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0073 subjects
FG00814 subjects
FG00916 subjects
FG0100 subjects
FG0110 subjects
Not treated
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0024 subjects
FG00310 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0033 subjects
FG004
Lack of antiviral response
FG0000 subjects
FG0010 subjects
FG00212 subjects
FG00318 subjects
FG004
Other reason not defined above
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Treated set which included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment regardless of randomisation.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1: 400mg DBV and 120mg FDV - 4w
Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)
BG001
Part 1: 600mg DBV and 120mg FDV - 4w
Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)
BG002
Part 2: 600mg DBV and 120mg FDV - 16w
Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
BG003
Part 2: 600mg DBV TID and 120mg FDV - 28w
Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
BG004
Part 2: 600mg DBV and 120mg FDV - 40w
Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
BG005
Part 2: 600mg DBV BID and 120mg FDV - 28w
Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
BG006
Part 2: 600mg DBV and 120mg FDV, no RBV - 28w
Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
BG007
Part 3: 600mg DBV and 120mg FDV - 16w
Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
BG008
Part 3: 800mg DBV and 120mg FDV - 24w
Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
BG009
Part 3: 600mg DBV and 120mg FDV - 24w
Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
BG010
Part 4: 600 mg DBV and 120mg FDV - 16w
Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
BG011
Part 4: 600 mg DBV and 120mg FDV - 24w
Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
BG012
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00015
BG00117
BG00281
BG00380
BG00477
BG00578
BG00646
BG00732
BG00826
BG00925
BG0101
BG0112
BG012480
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00050.8± 10.0
BG00150.8± 11.5
BG00248.6± 11.3
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0007
BG0017
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
Part 1: Rapid Virological Response (RVR)
Part 1: Rapid virological response (RVR), defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) <25IU/mL at Week 4 of treatment
FAS which included all randomised patients who were dispensed study medication and were documented to have taken at least one dose of study medication.
Posted
Number
95% Confidence Interval
Percentage of participants
4 weeks
ID
Title
Description
OG000
Part 1: 400mg DBV and 120mg FDV - 4w
Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)
OG001
Part 1: 600mg DBV and 120mg FDV - 4w
Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)
Units
Counts
Participants
OG00015
OG00117
Title
Denominators
Categories
Title
Measurements
OG00073.3(47.6 to 89.0)
OG001100.0(84.7 to 100.0)
Primary
Part 2: Sustained Virological Response (SVR)
Part 2: Sustained virological response (SVR), defined as HCV RNA <25 IU/mL and undetectable at 12 weeks after end of treatment
FAS
Posted
Number
Percentage of participants
From drug administration until 12 weeks after end of treatment, up to 52 weeks
ID
Title
Description
OG000
Part 2: 600mg DBV and 120mg FDV - 16w
Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
OG001
Part 2: 600mg DBV TID and 120mg FDV - 28w
Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
OG002
Part 2: 600mg DBV and 120mg FDV - 40w
Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Primary
Part 3 and 4: Sustained Virological Response (SVR)
Part 3 and 4: Sustained virological response (SVR) defined as HCV RNA <25IU/mL and undetectable at 12 weeks after end of treatment
FAS
Posted
Number
95% Confidence Interval
Percentage of participants
From drug administration until 12 weeks after end of treatment, up to 36 weeks
ID
Title
Description
OG000
Part 3: 600mg DBV and 120mg FDV - 16w
Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
OG001
Part 3: 800mg DBV and 120mg FDV - 24w
Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
OG002
Part 3: 600mg DBV and 120mg FDV - 24w
Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Secondary
Part 1: Time to Virological Response
Part 1: Time to virological response, defined as the timepoint of the first measurement of plasma HCV RNA level <25 IU/mL. The percentage of participants who achieved virological response within each time period are displayed for this outcome measure.
FAS
Posted
Number
Percentage of participants
From drug administration until end of drug administration, up to 4 weeks
ID
Title
Description
OG000
Part 1: 400mg DBV and 120mg FDV - 4w
Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)
OG001
Part 1: 600mg DBV and 120mg FDV - 4w
Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)
Units
Counts
Secondary
Part 2: Time to Virological Response
Part 2: Time to virological response, defined as the timepoint of the first measurement of plasma HCV RNA level <25 IU/mL. The percentage of participants who achieved virological response within each time period are displayed for this outcome measure.
FAS
Posted
Number
Percentage of participants
From drug administration until end of drug administration, up to 40 weeks
ID
Title
Description
OG000
Part 2: 600mg DBV and 120mg FDV - 16w
Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
OG001
Part 2: 600mg DBV TID and 120mg FDV - 28w
Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
OG002
Part 2: 600mg DBV and 120mg FDV - 40w
Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Secondary
Part 1 and 2: Plasma HCV RNA Level Not Detectable at Week 4
Part 1 and 2: Plasma Hepatitis C Virus Ribonucleic acid (HCV RNA) level not detectable at Week 4
FAS
Posted
Number
Percentage of participants
4 weeks
ID
Title
Description
OG000
Part 1: 400mg DBV and 120mg FDV - 4w
Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)
OG001
Part 1: 600mg DBV and 120mg FDV - 4w
Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)
OG002
Part 2: 600mg DBV and 120mg FDV - 16w
Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Secondary
Part 2: Sustained Virological Response at 4 and 24 Weeks After End of Treatment
Part 2: Sustained virological response at 4 and 24 weeks after end of treatment
FAS
Posted
Number
Percentage of participants
4 weeks and 24 weeks after the end of treatment, up to 64 weeks
ID
Title
Description
OG000
Part 2: 600mg DBV and 120mg FDV - 16w
Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
OG001
Part 2: 600mg DBV TID and 120mg FDV - 28w
Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
OG002
Part 2: 600mg DBV and 120mg FDV - 40w
Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Secondary
Part 3 and 4: Plasma HCV RNA Level <25 IU/mL at Week 4 and 12 of Treatment
Part 3 and 4: Plasma Hepatitis C Virus Ribonucleic acid (HCV RNA) level <25 IU/mL at week 4 and 12 of treatment
FAS
Posted
Number
Percentage of participants
Week 4 and 12
ID
Title
Description
OG000
Part 3: 600mg DBV and 120mg FDV - 16w
Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
OG001
Part 3: 800mg DBV and 120mg FDV - 24w
Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
OG002
Part 3: 600mg DBV and 120mg FDV - 24w
Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Secondary
Part 3 and 4: Sustained Virological Response (SVR) at 4 Weeks After End of Treatment
Part 3 and 4: Sustained virological response (SVR) at 4 weeks after end of treatment
FAS
Posted
Number
95% Confidence Interval
Percentage of participants
up to 28 weeks
ID
Title
Description
OG000
Part 3: 600mg DBV and 120mg FDV - 16w
Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
OG001
Part 3: 800mg DBV and 120mg FDV - 24w
Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
OG002
Part 3: 600mg DBV and 120mg FDV - 24w
Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Time Frame
From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Description
Not provided
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
Part 1: 400mg DBV and 120mg FDV - 4w
Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)
0
15
0
15
EG001
Part 1: 600mg DBV and 120mg FDV - 4w
Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)
0
17
0
17
EG002
Part 2: 600mg DBV and 120mg FDV - 16w
Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
3
81
76
81
EG003
Part 2: 600mg DBV TID and 120mg FDV - 28w
Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
8
80
71
80
EG004
Part 2: 600mg DBV and 120mg FDV - 40w
Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
6
77
74
77
EG005
Part 2: 600mg DBV BID and 120mg FDV - 28w
Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
8
78
73
78
EG006
Part 2: 600mg DBV and 120mg FDV, no RBV - 28w
Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
3
46
43
46
EG007
Part 3: 600mg DBV and 120mg FDV - 16w
Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
1
32
30
32
EG008
Part 3: 800mg DBV and 120mg FDV - 24w
Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
3
26
26
26
EG009
Part 3: 600mg DBV and 120mg FDV - 24w
Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
2
25
25
25
EG010
Part 4: 600 mg DBV and 120mg FDV - 16w
Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
0
1
1
1
EG011
Part 4: 600 mg DBV and 120mg FDV - 24w
Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
0
2
2
2
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG0031 affected80 at risk
EG0040 affected77 at risk
EG0050 affected78 at risk
EG0060 affected46 at risk
EG0070 affected32 at risk
EG0080 affected26 at risk
EG0090 affected25 at risk
EG0100 affected1 at risk
EG0110 affected2 at risk
Accident at work
Injury, poisoning and procedural complications
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Acute myocardial infarction
Cardiac disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Anaemia
Blood and lymphatic system disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Angina unstable
Cardiac disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Asthenia
General disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
B-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Blood potassium decreased
Investigations
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Brain injury
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Bundle branch block left
Cardiac disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Cardiac arrest
Cardiac disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Cardiopulmonary failure
Cardiac disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Cellulitis pharyngeal
Infections and infestations
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0021 affected81 at risk
EG003
Cholecystitis
Hepatobiliary disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Convulsion
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Coronary artery disease
Cardiac disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Coronary artery stenosis
Cardiac disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Dehydration
Metabolism and nutrition disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Depression
Psychiatric disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Diarrhoea
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Electrocardiogram QT prolonged
Investigations
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Erythema nodosum
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0021 affected81 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Gastritis
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Gastroenteritis
Infections and infestations
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Gun shot wound
Injury, poisoning and procedural complications
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Herpes zoster
Infections and infestations
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Limb traumatic amputation
Injury, poisoning and procedural complications
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Myocardial infarction
Cardiac disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Nausea
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0021 affected81 at risk
EG003
Prerenal failure
Renal and urinary disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Psychotic disorder
Psychiatric disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0021 affected81 at risk
EG003
Renal failure acute
Renal and urinary disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Retinal tear
Eye disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Syncope
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Toxic skin eruption
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Ventricular fibrillation
Cardiac disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Vomiting
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal discomfort
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0021 affected81 at risk
EG0031 affected80 at risk
EG0041 affected77 at risk
EG0056 affected78 at risk
EG0060 affected46 at risk
EG0074 affected32 at risk
EG0082 affected26 at risk
EG0092 affected25 at risk
EG0100 affected1 at risk
EG0110 affected2 at risk
Abdominal distension
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0024 affected81 at risk
EG003
Abdominal pain
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0027 affected81 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0026 affected81 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Anaemia
Blood and lymphatic system disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0021 affected81 at risk
EG003
Anxiety
Psychiatric disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0023 affected81 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0024 affected81 at risk
EG003
Asthenia
General disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG00224 affected81 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0023 affected81 at risk
EG003
Chest pain
General disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Chills
General disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0025 affected81 at risk
EG003
Constipation
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0024 affected81 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0027 affected81 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0024 affected81 at risk
EG003
Depressed mood
Psychiatric disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0021 affected81 at risk
EG003
Depression
Psychiatric disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0021 affected81 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Diarrhoea
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG00234 affected81 at risk
EG003
Disturbance in attention
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0023 affected81 at risk
EG003
Dizziness
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0024 affected81 at risk
EG003
Dry eye
Eye disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Dry mouth
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG00212 affected81 at risk
EG003
Dysgeusia
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0023 affected81 at risk
EG003
Dyspepsia
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0026 affected81 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0022 affected81 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0022 affected81 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0021 affected81 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Fatigue
General disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG00218 affected81 at risk
EG003
Flatulence
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0023 affected81 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Headache
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG00211 affected81 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Hypoaesthesia
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Hypoaesthesia oral
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Influenza like illness
General disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0022 affected81 at risk
EG003
Insomnia
Psychiatric disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG00211 affected81 at risk
EG003
Irritability
General disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0028 affected81 at risk
EG003
Jaundice
Hepatobiliary disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG00225 affected81 at risk
EG003
Lethargy
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0021 affected81 at risk
EG003
Lip dry
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0021 affected81 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0024 affected81 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0021 affected81 at risk
EG003
Nasopharyngitis
Infections and infestations
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0024 affected81 at risk
EG003
Nausea
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG00241 affected81 at risk
EG003
Ocular icterus
Eye disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0022 affected81 at risk
EG003
Oedema peripheral
General disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0022 affected81 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Paraesthesia
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG00210 affected81 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG00220 affected81 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG00216 affected81 at risk
EG003
Pyrexia
General disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0021 affected81 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG00221 affected81 at risk
EG003
Rash papulosquamous
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Sleep disorder
Psychiatric disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0023 affected81 at risk
EG003
Somnolence
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0026 affected81 at risk
EG003
Syncope
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0021 affected81 at risk
EG003
Tinnitus
Ear and labyrinth disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0021 affected81 at risk
EG003
Tremor
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0020 affected81 at risk
EG003
Urinary tract infection
Infections and infestations
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0021 affected81 at risk
EG003
Vomiting
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG00224 affected81 at risk
EG003
Weight decreased
Investigations
17.1
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected17 at risk
EG0028 affected81 at risk
EG003
There were only 3 patients entered in part 4 of the trial, therefore no formal analyses of efficacy data were performed.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Point of Contact
Title
Organization
Phone
Extension
Email
Boehringer Ingelheim Call Center
Boehringer Ingelheim
1-800-243-0127
clintriage.rdg@boehringer-ingelheim.com
ID
Term
D019698
Hepatitis C, Chronic
Ancestor Terms
ID
Term
D006526
Hepatitis C
D000086982
Blood-Borne Infections
D003141
Communicable Diseases
D007239
Infections
D006525
Hepatitis, Viral, Human
D014777
Virus Diseases
D018178
Flaviviridae Infections
D012327
RNA Virus Infections
D006521
Hepatitis, Chronic
D006505
Hepatitis
D008107
Liver Diseases
D004066
Digestive System Diseases
D002908
Chronic Disease
D020969
Disease Attributes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000592437
deleobuvir
C552340
faldaprevir
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
FG0063 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
19 subjects
FG0056 subjects
FG0065 subjects
FG0073 subjects
FG0087 subjects
FG0092 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
6 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0092 subjects
FG0100 subjects
FG0110 subjects
18 subjects
FG00518 subjects
FG00621 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0110 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
47.3
± 11.2
BG00448.9± 10.7
BG00547.9± 11.1
BG00645.3± 13.0
BG00748.9± 11.8
BG00847.2± 13.4
BG00946.5± 12.5
BG01059.0± NANot calculable due to only one patient in treatment group
BG01152.5± 4.9
BG01248.1± 11.4
36
BG00339
BG00441
BG00537
BG00622
BG00720
BG00811
BG00911
BG0101
BG0112
BG012234
Male
BG0008
BG00110
BG00245
BG00341
BG00436
BG00541
BG00624
BG00712
BG00815
BG00914
BG0100
BG0110
BG012246
OG003
Part 2: 600mg DBV BID and 120mg FDV - 28w
Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
OG004
Part 2: 600mg DBV and 120mg FDV, no RBV - 28w
Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Units
Counts
Participants
OG00081
OG00180
OG00277
OG00378
OG00446
Title
Denominators
Categories
Title
Measurements
OG00059.3
OG00158.8
OG00251.9
OG00369.2
OG00439.1
OG003
Part 4: 600 mg DBV and 120mg FDV - 16w
Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
OG004
Part 4: 600 mg DBV and 120mg FDV - 24w
Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
Units
Counts
Participants
OG00032
OG00126
OG00225
OG0031
OG0042
Title
Denominators
Categories
Title
Measurements
OG00065.6(46.8 to 81.4)
OG00119.2(6.6 to 39.4)
OG00212.0(2.5 to 31.2)
OG003NA(NA to NA)The study was stopped before data were collected from the participants in Part 4
OG004NA(NA to NA)The study was stopped before data were collected from the participants in Part 4
Participants
OG00015
OG00117
Title
Denominators
Categories
<= 2 weeks
Title
Measurements
OG0006.7
OG00111.8
<= 4 weeks
Title
Measurements
OG00020.0
OG00147.1
<= 8 weeks
Title
Measurements
OG00053.3
OG00141.2
<= 12 weeks
Title
Measurements
OG0000.0
OG0010.0
<= 16 weeks
Title
Measurements
OG0006.7
OG0010.0
<= 28 weeks
Title
Measurements
OG0000.0
OG0010.0
<= 32 weeks
Title
Measurements
OG0006.7
OG0010.0
<= 40 weeks
Title
Measurements
OG0000.0
OG0010.0
> 40 weeks
Title
Measurements
OG0000.0
OG0010.0
Never
Title
Measurements
OG0006.7
OG0010.0
OG003
Part 2: 600mg DBV BID and 120mg FDV - 28w
Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
OG004
Part 2: 600mg DBV and 120mg FDV, no RBV - 28w
Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Units
Counts
Participants
OG00081
OG00180
OG00277
OG00378
OG00446
Title
Denominators
Categories
Day 0 (N=81, 80, 77, 78, 46)
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG0030.0
OG0040.0
Day 8(N=75, 72, 72, 75, 44)
Title
Measurements
OG0003.8
OG0017.7
OG0021.4
OG003
Day 15 (N=62, 61, 63, 60, 33)
Title
Measurements
OG00019.4
OG00120.7
OG0029.9
OG003
Day 29 (N=29, 32, 27, 32, 21)
Title
Measurements
OG00061.5
OG00155.5
OG00259.4
OG003
Day 43 (N=16, 12, 13, 18, 12)
Title
Measurements
OG00078.8
OG00183.3
OG00280.5
OG003
Day 57 (N=9, 8, 9, 11, 9)
Title
Measurements
OG00088.1
OG00188.9
OG00285.1
OG003
Day 85 (N=9, 7, 8, 11, 9)
Title
Measurements
OG00088.1
OG00190.3
OG00286.8
OG003
Day 113 (N=9, 7, 8, 11, 8)
Title
Measurements
OG00088.1
OG00190.3
OG00286.8
OG003
Day 141 (N=9, 7, 8, 11, 8)
Title
Measurements
OG00088.1
OG00190.3
OG00286.8
OG003
Day 169 (N=9, 7, 8, 11, 8)
Title
Measurements
OG00088.1
OG00190.3
OG00286.8
OG003
Day 197 (N=9, 7, 8, 11, 8)
Title
Measurements
OG00088.1
OG00190.3
OG00286.8
OG003
OG003
Part 2: 600mg DBV TID and 120mg FDV - 28w
Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
OG004
Part 2: 600mg DBV and 120mg FDV - 40w
Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
OG005
Part 2: 600mg DBV BID and 120mg FDV - 28w
Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
OG006
Part 2: 600mg DBV and 120mg FDV, no RBV - 28w
Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Units
Counts
Participants
OG00015
OG00117
OG00281
OG00380
OG00477
OG00578
OG00646
Title
Denominators
Categories
Title
Measurements
OG00020.0
OG00170.6
OG00265.4
OG00360.0
OG00463.6
OG00556.4
OG00650.0
OG003
Part 2: 600mg DBV BID and 120mg FDV - 28w
Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
OG004
Part 2: 600mg DBV and 120mg FDV, no RBV - 28w
Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Units
Counts
Participants
OG00081
OG00180
OG00277
OG00378
OG00446
Title
Denominators
Categories
SVR4
Title
Measurements
OG00060.5
OG00162.5
OG00254.5
OG00369.2
OG00443.5
SVR24
Title
Measurements
OG00058.0
OG00158.8
OG00249.4
OG003
OG003
Part 4: 600 mg DBV and 120mg FDV - 16w
Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
OG004
Part 4: 600 mg DBV and 120mg FDV - 24w
Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
Units
Counts
Participants
OG00032
OG00126
OG00225
OG0031
OG0042
Title
Denominators
Categories
Title
Measurements
OG00075.0
OG00126.9
OG00232.0
OG003NAThe study was stopped before data were collected from the participants in Part 4
OG004NAThe study was stopped before data were collected from the participants in Part 4
OG003
Part 4: 600 mg DBV and 120mg FDV - 16w
Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
OG004
Part 4: 600 mg DBV and 120mg FDV - 24w
Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
Units
Counts
Participants
OG00032
OG00126
OG00225
OG0031
OG0042
Title
Denominators
Categories
Title
Measurements
OG00075.0(56.6 to 88.5)
OG00119.2(6.6 to 39.4)
OG00212.0(2.5 to 31.2)
OG003NA(NA to NA)The study was stopped before data were collected from the participants in Part 4
OG004NA(NA to NA)The study was stopped before data were collected from the participants in Part 4