A Study to Evaluate Treatment of Hepatitis C Virus Infect... | NCT02486406 | Trialant
NCT02486406
Sponsor
AbbVie
Status
Completed
Last Update Posted
Oct 5, 2021Actual
Enrollment
64Actual
Phase
Phase 2Phase 3
Conditions
Chronic Hepatitis C Infection
Interventions
Ombitasvir/paritaprevir/ritonavir
Dasabuvir
Ribavirin
Ombitasvir mini tablet
Paritaprevir mini tablet
Ritonavir mini tablet
Dasabuvir mini tablet
Ribavirin solution
Countries
United States
Belgium
Germany
Puerto Rico
Spain
Protocol Section
Identification Module
NCT ID
NCT02486406
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
M14-748
Secondary IDs
ID
Type
Description
Link
2015-000111-41
EudraCT Number
Brief Title
A Study to Evaluate Treatment of Hepatitis C Virus Infection in Pediatric Subjects
Official Title
An Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Ombitasvir (OBV), Paritaprevir (PTV), Ritonavir (RTV) With or Without Dasabuvir (DSV) and With or Without Ribavirin (RBV) in Pediatric Subjects With Genotype 1 or 4 Chronic Hepatitis C Virus (HCV) Infection (ZIRCON)
Acronym
ZIRCON
Organization
AbbVieINDUSTRY
Status Module
Record Verification Date
Sep 2021
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
Oct 28, 2015Actual
Primary Completion Date
Nov 19, 2020Actual
Completion Date
Nov 19, 2020Actual
First Submitted Date
Jun 17, 2015
First Submission Date that Met QC Criteria
Jun 29, 2015
First Posted Date
Jul 1, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 7, 2021
Results First Submitted that Met QC Criteria
Sep 7, 2021
Results First Posted Date
Oct 5, 2021Actual
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
Sep 7, 2021
Last Update Posted Date
Oct 5, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AbbVieINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This was a Phase 2/3, open-label, multicenter study to evaluate the pharmacokinetics (PK), efficacy, and safety of ombitasvir/paritaprevir/ritonavir (OBV/PTV/RTV) with or without dasabuvir (DSV) and with or without ribavirin (RBV) in Hepatitis C virus (HCV) genotype 1 or 4 (GT1 or GT4)-infected pediatric participants of ≥ 3 to 17 years of age.
Detailed Description
The study population for Part 1, the PK study, included GT1-infected participants who were noncirrhotic and treatment-naïve (TN). Part 2, the safety and efficacy study, included GT1 or GT4-infected participants who were TN or interferon ([IFN] or Pegylated-interferon alfa-2a or 2b [pegIFN] with or without RBV) treatment-experienced (TE) without cirrhosis or with compensated cirrhosis. In Part 1 and Part 2, the treatment regimen and duration were dependent on HCV GT, GT1 subtype, and cirrhosis status.
Conditions Module
Conditions
Chronic Hepatitis C Infection
Keywords
Hepatitis C Virus
Hepatitis C Genotype 1
Hepatitis C Genotype 4
Pediatric
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 2Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
64Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Adult tablet, 12-17 yr, Part 1
Experimental
Participants with HCV GT1b without cirrhosis received the adult 3-DAA (OBV/PTV/RTV and DSV) regimen: two 12.5 mg ombitasvir /75 mg paritaprevir /50 mg ritonavir tablets taken orally every morning (QD) and one dasabuvir 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis received 12-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label.
Drug: Ombitasvir/paritaprevir/ritonavir
Drug: Dasabuvir
Drug: Ribavirin
Adult tablet, 12-17 yr, Part 2
Experimental
Participants with HCV GT1b received the adult 3-DAA (OBV/PTV/RTV and DSV) regimen: two 12.5 mg ombitasvir /75mg paritaprevir /50 mg ritonavir tablets taken orally every morning (QD) and one dasabuvir 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis received 12-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label. Participants with HCV GT1a with compensated cirrhosis received 24-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label. Participants with HCV GT4 received 12-week treatment with the OBV/PTV/RTV formulation and ribavirin 200 mg tablets were administered orally per local label.
Drug: Ombitasvir/paritaprevir/ritonavir
Drug: Dasabuvir
Drug: Ribavirin
Mini tablet, 9-11 yr, Part 1
Experimental
Participants with HCV GT1b without cirrhosis were to receive the mini-tablet 3-DAA (OBV, PTV, RTV, and DSV) regimen for 12 weeks: ombitasvir 0.3 mg, paritaprevir 1.0 mg, and ritonavir 1.0 mg mini-tablets administered orally QD based on body weight and dasabuvir taken orally BID as 3.08 mg mini-tablets based on body weight. Participants with HCV GT1a without cirrhosis received 12-week treatment with the mini-tablet 3-DAA regimen and ribavirin was provided as a 40 mg/mL oral solution and administered per local label.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ombitasvir/paritaprevir/ritonavir
Drug
Film-coated tablet for oral use
Adult tablet, 12-17 yr, Part 1
Adult tablet, 12-17 yr, Part 2
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 1: Maximum Plasma Concentration (Cmax) of Ombitasvir (OBV)
Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administrated and before administration of a second dose.
At Week 2
Part 1: Concentration of Drug in Blood Plasma Over Time [Area Under the Curve (AUC)] of Ombitasvir (OBV)
AUC is a measure of how long and how much drug is present in the body after dosing. The amount of ombitasvir present was measured up to 24 hours after dosing.
At Week 2
Part 1: Lowest Plasma Concentration (Ctrough) of Ombitasvir (OBV)
Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data.
At Weeks 2 and 8
Part 1: Maximum Plasma Concentration (Cmax) of Paritaprevir (PTV)
Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administrated and before administration of a second dose.
At Week 2
Part 1: Concentration of Drug in Blood Plasma Over Time [Area Under the Curve (AUC)] of Paritaprevir (PTV)
AUC is a measure of how long and how much drug is present in the body after dosing. The amount of paritaprevir present was measured up to 24 hours after dosing.
At Week 2
Part 1: Lowest Plasma Concentration (Ctrough) of Paritaprevir (PTV)
Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data.
Secondary Outcomes
Measure
Description
Time Frame
Parts 1 and 2: Percentage of Participants With Sustained Virologic Response 12 Weeks After the Last Actual Dose of Study Drug (SVR12) Summarized by Formulation, Age and Weight Group, and Across All Subjects on the Adult Formulations
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) < lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
12 weeks after last dose of study drug (Week 24 or 36 depending on treatment duration)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Positive anti-hepatitis C virus antibody (HCV Ab) and HCV ribonucleic acid (RNA) ≥ 1000 IU/mL at the time of screening
HCV genotype 1 for enrollment into Part 1 of the study and genotype 1 or 4 for enrollment into Part 2
Parent or legal guardian with the willingness and ability to provide written informed consent and participant willing and able to give assent, as appropriate for age and country
Exclusion Criteria:
Female participant who is pregnant, breastfeeding or is considering becoming pregnant
Use of known strong inducers and inhibitors (e.g., gemfibrozil) of cytochrome P450 2C8 (CYP2C8) in participants receiving dasabuvir, or strong or moderate inducers of CYP3A, within 2 weeks or 10 half-lives, whichever is longer, of the respective medication/supplement prior to study drug administration.
Positive test result for Hepatitis B surface antigen (HbsAg) or anti-human immunodeficiency virus antibody (HIV Ab) test
Current enrollment in another interventional clinical study, previous enrollment in this study, prior or current use of any investigational or commercially available anti-HCV agents other than interferons or ribavirin or receipt of any investigational product within 6 weeks prior to study drug administration
Rosenthal P, Narkewicz MR, Yao BB, Jolley CD, Lobritto SJ, Wen J, Molleston JP, Hsu EK, Jonas MM, Zha J, Liu L, Leung DH. Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir Mini-Tabs Plus Ribavirin for Children Aged 3-11 Years with Hepatitis C Genotype 1a. Adv Ther. 2020 Jul;37(7):3299-3310. doi: 10.1007/s12325-020-01389-9. Epub 2020 May 25.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Safety population: all participants who received at least one dose of study drug in Part 1 or Part 2
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Adult Tablet, 12-17 yr, Part 1
Participants with HCV GT1b without cirrhosis received the adult 3-DAA (OBV/PTV/RTV and DSV) regimen: two 12.5 mg ombitasvir /75 mg paritaprevir /50 mg ritonavir tablets taken orally every morning (QD) and one dasabuvir 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis received 12-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label.
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
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Aug 21, 2017
Sep 7, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Canada
Switzerland
United Kingdom
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-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
Drug: Ombitasvir mini tablet
Drug: Paritaprevir mini tablet
Drug: Ritonavir mini tablet
Drug: Dasabuvir mini tablet
Drug: Ribavirin solution
Mini tablet, 3-8 yr, Part 1
Experimental
Participants with HCV GT1b without cirrhosis were to receive the mini-tablet 3-DAA (OBV, PTV, RTV, and DSV) regimen for 12 weeks: ombitasvir 0.3 mg, paritaprevir 1.0 mg, and ritonavir 1.0 mg mini-tablets administered orally QD based on body weight and dasabuvir taken orally BID as 3.08 mg mini-tablets based on body weight. Participants with HCV GT1a without cirrhosis received 12-week treatment with the mini-tablet 3-DAA regimen and ribavirin was provided as a 40 mg/mL oral solution and administered per local label.
Drug: Ombitasvir mini tablet
Drug: Paritaprevir mini tablet
Drug: Ritonavir mini tablet
Drug: Dasabuvir mini tablet
Drug: Ribavirin solution
Ombitasvir also known as ABT-267
Paritaprevir also known as ABT-450
Ombitsvir/paritaprevir/ritonavir also known as Viekirax
Dasabuvir
Drug
Film-coated tablet for oral use
Adult tablet, 12-17 yr, Part 1
Adult tablet, 12-17 yr, Part 2
Exviera
ABT-333
Ribavirin
Drug
Film-coated tablet for oral use
Adult tablet, 12-17 yr, Part 1
Adult tablet, 12-17 yr, Part 2
Ombitasvir mini tablet
Drug
Film-coated tablet for oral use
Mini tablet, 3-8 yr, Part 1
Mini tablet, 9-11 yr, Part 1
ABT-267
Paritaprevir mini tablet
Drug
Film-coated tablet for oral use
Mini tablet, 3-8 yr, Part 1
Mini tablet, 9-11 yr, Part 1
ABT-450
Ritonavir mini tablet
Drug
Film-coated tablet for oral use
Mini tablet, 3-8 yr, Part 1
Mini tablet, 9-11 yr, Part 1
Dasabuvir mini tablet
Drug
Film-coated tablet for oral use
Mini tablet, 3-8 yr, Part 1
Mini tablet, 9-11 yr, Part 1
Exviera
ABT-333
Ribavirin solution
Drug
Oral solution
Mini tablet, 3-8 yr, Part 1
Mini tablet, 9-11 yr, Part 1
At Weeks 2 and 8
Part 1: Maximum Plasma Concentration (Cmax) of Dasabuvir (DSV)
Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administrated and before administration of a second dose.
At Week 2
Part 1: Concentration of Drug in Blood Plasma Against Time [Area Under the Curve (AUC)] of Dasabuvir (DSV)
AUC is a measure of how long and how much drug is present in the body after dosing. The amount of dasabuvir present was measured up to 12 hours after dosing. For two subjects in the 15-29 kg group, the 24 h concentration was used as the 12 h concentration due to the significant sampling time deviation. For one subject in the 30-44 kg group, the 24 h concentration was used as the 12 h concentration due to the significant sampling time deviation.
At Week 2
Part 1: Lowest Plasma Concentration (Ctrough) of Dasabuvir (DSV)
Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data.
At Weeks 2 and 8
Part 1: Maximum Plasma Concentration (Cmax) of Ritonavir (RTV)
Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administrated and before administration of a second dose.
At Week 2
Part 1: Concentration of Drug in Blood Plasma Over Time [Area Under the Curve (AUC)] of Ritonavir (RTV)
AUC is a measure of how long and how much drug is present in the body after dosing. The amount of ritonavir present was measured up to 24 hours after dosing.
At Week 2
Part 1: Lowest Plasma Concentration (Ctrough) of Ritonavir (RTV)
Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data.
At Weeks 2 and 8
Parts 1 and 2: Percentage of Participants With Sustained Virologic Response 12 Weeks After the Last Actual Dose of Study Drug (SVR12)
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) < lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
12 weeks after last dose of study drug (Week 24 or 36 depending on treatment duration)
Parts 1 & 2: Percentage of Participants With Sustained Virologic Response 24 Weeks After the Last Actual Dose of Study Drug (SVR24), Summarized by Formulation, Age and Weight Group, Across All Subjects, and Across All Subjects on the Adult Formulations
SVR24 is defined as hepatitis C virus ribonucleic acid (HCV RNA) < lower limit of quantification (LLOQ) 24 weeks after the last actual dose of study drug.
24 weeks after last dose of study drug (Week 36 or 48 depending on treatment duration)
Parts 1 and 2: Percentage of Participants With Alanine Aminotransferase (ALT) Normalization During Treatment by Formulation, Age and Weight Group, Across All Subjects, and Across All Subjects on the Adult Formulations
Alanine aminotransferase (ALT) normalization during treatment is defined as ALT ≤ the upper limit of normal (ULN) at the final treatment visit for participants with ALT > ULN at baseline.
12 or 24 weeks after starting study drug, depending on treatment duration
Aurora
Colorado
80045
United States
University of Florida - Archer /ID# 136830
Gainesville
Florida
32610
United States
Advent Health /ID# 167663
Orlando
Florida
32803
United States
Indiana University /ID# 137015
Indianapolis
Indiana
46202
United States
Boston Childrens Hospital /ID# 137174
Boston
Massachusetts
02115
United States
Boston Medical Center /ID# 136831
Boston
Massachusetts
02118
United States
Columbia Univ Medical Center /ID# 136431
New York
New York
10032-3725
United States
Children's Hospital of Philadelphia /ID# 137018
Philadelphia
Pennsylvania
19104
United States
Baylor College of Medicine /ID# 136590
Houston
Texas
77030-3411
United States
Seattle Children's Hospital /ID# 137019
Seattle
Washington
98105
United States
Cliniques Universitaires Saint-Luc /ID# 136910
Brussels
Brussels Capital
1200
Belgium
UZ Leuven /ID# 136911
Leuven
3000
Belgium
Charite Universitaetsmedizin Berlin /ID# 141620
Berlin
10117
Germany
Universitaetsklinikum Freiburg /ID# 141618
Freiburg im Breisgau
79106
Germany
Helios Klinikum Wuppertal /ID# 142883
Wuppertal
42283
Germany
San Jorge Children Hospital /ID# 136832
San Juan
00912-3310
Puerto Rico
Hospital Sant Joan de Deu /ID# 137096
Esplugues de Llobregat
Barcelona
08950
Spain
Hospital Universitario Vall d'Hebron /ID# 137098
Barcelona
08035
Spain
Hospital Universitario La Paz /ID# 137094
Madrid
28046
Spain
Hospital Universitario y Politecnico La Fe /ID# 137097
Valencia
46026
Spain
FG001
Adult Tablet, 12-17 yr, Part 2
Participants with HCV GT1b received the adult 3-DAA (OBV/PTV/RTV and DSV) regimen: two 12.5 mg ombitasvir /75mg paritaprevir /50 mg ritonavir tablets taken orally every morning (QD) and one dasabuvir 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis received 12-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label. Participants with HCV GT1a with compensated cirrhosis received 24-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label. Participants with HCV GT4 received 12-week treatment with the OBV/PTV/RTV formulation and ribavirin 200 mg tablets were administered orally per local label.
FG002
Mini Tablet, 9-11 yr, Part 1
Participants with HCV GT1b without cirrhosis were to receive the mini-tablet 3-DAA (OBV, PTV, RTV, and DSV) regimen for 12 weeks: ombitasvir 0.3 mg, paritaprevir 1.0 mg, and ritonavir 1.0 mg mini-tablets administered orally QD based on body weight and dasabuvir taken orally BID as 3.08 mg mini-tablets based on body weight. Participants with HCV GT1a without cirrhosis received 12-week treatment with the mini-tablet 3-DAA regimen and ribavirin was provided as a 40 mg/mL oral solution and administered per local label.
FG003
Mini Tablet, 3-8 yr, Part 1
Participants with HCV GT1b without cirrhosis were to receive the mini-tablet 3-DAA (OBV, PTV, RTV, and DSV) regimen for 12 weeks: ombitasvir 0.3 mg, paritaprevir 1.0 mg, and ritonavir 1.0 mg mini-tablets administered orally QD based on body weight and dasabuvir taken orally BID as 3.08 mg mini-tablets based on body weight. Participants with HCV GT1a without cirrhosis received 12-week treatment with the mini-tablet 3-DAA regimen and ribavirin was provided as a 40 mg/mL oral solution and administered per local label.
FG00012 subjects
FG00126 subjects
FG00212 subjects
FG00314 subjects
COMPLETED
FG00010 subjects
FG00123 subjects
FG00210 subjects
FG00310 subjects
NOT COMPLETED
FG0002 subjects
FG0013 subjects
FG0022 subjects
FG0034 subjects
Type
Comment
Reasons
Withdrew consent
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
Lost to Follow-up
FG0001 subjects
FG0013 subjects
FG0021 subjects
FG0033 subjects
Other, not specified
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Intention-to-treat population: all participants who received at least one dose of study drug in Part 1 or Part 2
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Adult Tablet, 12-17 yr, Part 1
Participants with HCV GT1b without cirrhosis received the adult 3-DAA (OBV/PTV/RTV and DSV) regimen: two 12.5 mg ombitasvir /75 mg paritaprevir /50 mg ritonavir tablets taken orally every morning (QD) and one dasabuvir 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis received 12-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label.
BG001
Adult Tablet, 12-17 yr, Part 2
Participants with HCV GT1b received the adult 3-DAA (OBV/PTV/RTV and DSV) regimen: two 12.5 mg ombitasvir /75mg paritaprevir /50 mg ritonavir tablets taken orally every morning (QD) and one dasabuvir 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis received 12-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label. Participants with HCV GT1a with compensated cirrhosis received 24-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label. Participants with HCV GT4 received 12-week treatment with the OBV/PTV/RTV formulation and ribavirin 200 mg tablets were administered orally per local label.
BG002
Mini Tablet, 9-11 yr, Part 1
Participants with HCV GT1b without cirrhosis were to receive the mini-tablet 3-DAA (OBV, PTV, RTV, and DSV) regimen for 12 weeks: ombitasvir 0.3 mg, paritaprevir 1.0 mg, and ritonavir 1.0 mg mini-tablets administered orally QD based on body weight and dasabuvir taken orally BID as 3.08 mg mini-tablets based on body weight. Participants with HCV GT1a without cirrhosis received 12-week treatment with the mini-tablet 3-DAA regimen and ribavirin was provided as a 40 mg/mL oral solution and administered per local label.
BG003
Mini Tablet, 3-8 yr, Part 1
Participants with HCV GT1b without cirrhosis were to receive the mini-tablet 3-DAA (OBV, PTV, RTV, and DSV) regimen for 12 weeks: ombitasvir 0.3 mg, paritaprevir 1.0 mg, and ritonavir 1.0 mg mini-tablets administered orally QD based on body weight and dasabuvir taken orally BID as 3.08 mg mini-tablets based on body weight. Participants with HCV GT1a without cirrhosis received 12-week treatment with the mini-tablet 3-DAA regimen and ribavirin was provided as a 40 mg/mL oral solution and administered per local label.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00012
BG00126
BG00212
BG00314
BG00464
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
BG00015.4± 1.73
BG00115.0± 1.68
BG0029.8± 0.83
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG0009
BG00116
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
White
Title
Measurements
BG0006
BG00123
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: Maximum Plasma Concentration (Cmax) of Ombitasvir (OBV)
Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administrated and before administration of a second dose.
Intention-to-treat population: all participants who received at least one dose of study drug in Part 1 with available data
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
At Week 2
ID
Title
Description
OG000
15 - 29 kg Body Weight
Participants in Part 1 of the study who weighed between 15-29 kg at the time of enrollment
OG001
30 - 44 kg Body Weight
Participants in Part 1 of the study who weighed between 30-44 kg at the time of enrollment
OG002
≥ 45 kg Body Weight
Participants in Part 1 of the study who weighed ≥ 45 kg at the time of enrollment
Units
Counts
Participants
OG00012
OG0019
OG00213
Title
Denominators
Categories
Title
Measurements
OG00099.6± 27
OG001116± 14
OG00283.7± 39
Primary
Part 1: Concentration of Drug in Blood Plasma Over Time [Area Under the Curve (AUC)] of Ombitasvir (OBV)
AUC is a measure of how long and how much drug is present in the body after dosing. The amount of ombitasvir present was measured up to 24 hours after dosing.
Intention-to-treat population: all participants who received at least one dose of study drug in Part 1 with available data
Posted
Geometric Mean
Geometric Coefficient of Variation
ng•h/mL
At Week 2
ID
Title
Description
OG000
15 - 29 kg Body Weight
Participants in Part 1 of the study who weighed between 15-29 kg at the time of enrollment
OG001
30 - 44 kg Body Weight
Participants in Part 1 of the study who weighed between 30-44 kg at the time of enrollment
OG002
≥ 45 kg Body Weight
Participants in Part 1 of the study who weighed ≥ 45 kg at the time of enrollment
Units
Counts
Participants
Primary
Part 1: Lowest Plasma Concentration (Ctrough) of Ombitasvir (OBV)
Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data.
Intention-to-treat population: all participants who received at least one dose of study drug in Part 1 with available data
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
At Weeks 2 and 8
ID
Title
Description
OG000
15 - 29 kg Body Weight
Participants in Part 1 of the study who weighed between 15-29 kg at the time of enrollment
OG001
30 - 44 kg Body Weight
Participants in Part 1 of the study who weighed between 30-44 kg at the time of enrollment
OG002
≥ 45 kg Body Weight
Participants in Part 1 of the study who weighed ≥ 45 kg at the time of enrollment
Units
Counts
Participants
Primary
Part 1: Maximum Plasma Concentration (Cmax) of Paritaprevir (PTV)
Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administrated and before administration of a second dose.
Intention-to-treat population: all participants who received at least one dose of study drug in Part 1 with available data
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
At Week 2
ID
Title
Description
OG000
15 - 29 kg Body Weight
Participants in Part 1 of the study who weighed between 15-29 kg at the time of enrollment
OG001
30 - 44 kg Body Weight
Participants in Part 1 of the study who weighed between 30-44 kg at the time of enrollment
OG002
≥ 45 kg Body Weight
Participants in Part 1 of the study who weighed ≥ 45 kg at the time of enrollment
Units
Counts
Participants
Primary
Part 1: Concentration of Drug in Blood Plasma Over Time [Area Under the Curve (AUC)] of Paritaprevir (PTV)
AUC is a measure of how long and how much drug is present in the body after dosing. The amount of paritaprevir present was measured up to 24 hours after dosing.
Intention-to-treat population: all participants who received at least one dose of study drug in Part 1 with available data
Posted
Geometric Mean
Geometric Coefficient of Variation
ng•h/mL
At Week 2
ID
Title
Description
OG000
15 - 29 kg Body Weight
Participants in Part 1 of the study who weighed between 15-29 kg at the time of enrollment
OG001
30 - 44 kg Body Weight
Participants in Part 1 of the study who weighed between 30-44 kg at the time of enrollment
OG002
≥ 45 kg Body Weight
Participants in Part 1 of the study who weighed ≥ 45 kg at the time of enrollment
Units
Counts
Participants
Primary
Part 1: Lowest Plasma Concentration (Ctrough) of Paritaprevir (PTV)
Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data.
Intention-to-treat population: all participants who received at least one dose of study drug in Part 1 with available data
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
At Weeks 2 and 8
ID
Title
Description
OG000
15 - 29 kg Body Weight
Participants in Part 1 of the study who weighed between 15-29 kg at the time of enrollment
OG001
30 - 44 kg Body Weight
Participants in Part 1 of the study who weighed between 30-44 kg at the time of enrollment
OG002
≥ 45 kg Body Weight
Participants in Part 1 of the study who weighed ≥ 45 kg at the time of enrollment
Units
Counts
Participants
Primary
Part 1: Maximum Plasma Concentration (Cmax) of Dasabuvir (DSV)
Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administrated and before administration of a second dose.
Intention-to-treat population: all participants who received at least one dose of study drug in Part 1 with available data
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
At Week 2
ID
Title
Description
OG000
15 - 29 kg Body Weight
Participants in Part 1 of the study who weighed between 15-29 kg at the time of enrollment
OG001
30 - 44 kg Body Weight
Participants in Part 1 of the study who weighed between 30-44 kg at the time of enrollment
OG002
≥ 45 kg Body Weight
Participants in Part 1 of the study who weighed ≥ 45 kg at the time of enrollment
Units
Counts
Participants
Primary
Part 1: Concentration of Drug in Blood Plasma Against Time [Area Under the Curve (AUC)] of Dasabuvir (DSV)
AUC is a measure of how long and how much drug is present in the body after dosing. The amount of dasabuvir present was measured up to 12 hours after dosing. For two subjects in the 15-29 kg group, the 24 h concentration was used as the 12 h concentration due to the significant sampling time deviation. For one subject in the 30-44 kg group, the 24 h concentration was used as the 12 h concentration due to the significant sampling time deviation.
Intention-to-treat population: all participants who received at least one dose of study drug in Part 1 with available data
Posted
Geometric Mean
Geometric Coefficient of Variation
ng•h/mL
At Week 2
ID
Title
Description
OG000
15 - 29 kg Body Weight
Participants in Part 1 of the study who weighed between 15-29 kg at the time of enrollment
OG001
30 - 44 kg Body Weight
Participants in Part 1 of the study who weighed between 30-44 kg at the time of enrollment
OG002
≥ 45 kg Body Weight
Participants in Part 1 of the study who weighed ≥ 45 kg at the time of enrollment
Primary
Part 1: Lowest Plasma Concentration (Ctrough) of Dasabuvir (DSV)
Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data.
Intention-to-treat population: all participants who received at least one dose of study drug in Part 1 with available data
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
At Weeks 2 and 8
ID
Title
Description
OG000
15 - 29 kg Body Weight
Participants in Part 1 of the study who weighed between 15-29 kg at the time of enrollment
OG001
30 - 44 kg Body Weight
Participants in Part 1 of the study who weighed between 30-44 kg at the time of enrollment
OG002
≥ 45 kg Body Weight
Participants in Part 1 of the study who weighed ≥ 45 kg at the time of enrollment
Units
Counts
Participants
Primary
Part 1: Maximum Plasma Concentration (Cmax) of Ritonavir (RTV)
Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administrated and before administration of a second dose.
Intention-to-treat population: all participants who received at least one dose of study drug in Part 1 with available data
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
At Week 2
ID
Title
Description
OG000
15 - 29 kg Body Weight
Participants in Part 1 of the study who weighed between 15-29 kg at the time of enrollment
OG001
30 - 44 kg Body Weight
Participants in Part 1 of the study who weighed between 30-44 kg at the time of enrollment
OG002
≥ 45 kg Body Weight
Participants in Part 1 of the study who weighed ≥ 45 kg at the time of enrollment
Units
Counts
Participants
Primary
Part 1: Concentration of Drug in Blood Plasma Over Time [Area Under the Curve (AUC)] of Ritonavir (RTV)
AUC is a measure of how long and how much drug is present in the body after dosing. The amount of ritonavir present was measured up to 24 hours after dosing.
Intention-to-treat population: all participants who received at least one dose of study drug in Part 1 with available data
Posted
Geometric Mean
Geometric Coefficient of Variation
ng•h/mL
At Week 2
ID
Title
Description
OG000
15 - 29 kg Body Weight
Participants in Part 1 of the study who weighed between 15-29 kg at the time of enrollment
OG001
30 - 44 kg Body Weight
Participants in Part 1 of the study who weighed between 30-44 kg at the time of enrollment
OG002
≥ 45 kg Body Weight
Participants in Part 1 of the study who weighed ≥ 45 kg at the time of enrollment
Units
Counts
Participants
Primary
Part 1: Lowest Plasma Concentration (Ctrough) of Ritonavir (RTV)
Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data.
Intention-to-treat population: all participants who received at least one dose of study drug in Part 1 with available data
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
At Weeks 2 and 8
ID
Title
Description
OG000
15 - 29 kg Body Weight
Participants in Part 1 of the study who weighed between 15-29 kg at the time of enrollment
OG001
30 - 44 kg Body Weight
Participants in Part 1 of the study who weighed between 30-44 kg at the time of enrollment
OG002
≥ 45 kg Body Weight
Participants in Part 1 of the study who weighed ≥ 45 kg at the time of enrollment
Units
Counts
Participants
Primary
Parts 1 and 2: Percentage of Participants With Sustained Virologic Response 12 Weeks After the Last Actual Dose of Study Drug (SVR12)
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) < lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
Intention-to-treat population: all participants who received at least one dose of study drug in Part 1 or 2; those with missing data after backwards imputation were treated as nonresponders
Posted
Number
95% Confidence Interval
percentage of participants
12 weeks after last dose of study drug (Week 24 or 36 depending on treatment duration)
ID
Title
Description
OG000
All Participants, Total
All participants who received at least one dose of study drug in Part 1 or Part 2
Units
Counts
Participants
OG000
Secondary
Parts 1 and 2: Percentage of Participants With Sustained Virologic Response 12 Weeks After the Last Actual Dose of Study Drug (SVR12) Summarized by Formulation, Age and Weight Group, and Across All Subjects on the Adult Formulations
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) < lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
Intention-to-treat population: all participants who received at least one dose of study drug in Part 1 or 2; those with missing data after backwards imputation were treated as nonresponders
Posted
Number
95% Confidence Interval
percentage of participants
12 weeks after last dose of study drug (Week 24 or 36 depending on treatment duration)
ID
Title
Description
OG000
Adult Tablet, 12-17 YR, ≥ 45 kg
Participants age 12-17 years old who received the adult formulation and weighed ≥ 45 kg
OG001
Mini-tablet, 9-11 YR, 15 to 29 kg
Participants age 9-11 years old who received the mini-tablet formulation and weighed 15 to 29 kg
OG002
Mini-tablet, 9-11 YR, 30 to 44 kg
Participants age 9-11 years old who received the mini-tablet formulation and weighed 30 to 44 kg
Secondary
Parts 1 & 2: Percentage of Participants With Sustained Virologic Response 24 Weeks After the Last Actual Dose of Study Drug (SVR24), Summarized by Formulation, Age and Weight Group, Across All Subjects, and Across All Subjects on the Adult Formulations
SVR24 is defined as hepatitis C virus ribonucleic acid (HCV RNA) < lower limit of quantification (LLOQ) 24 weeks after the last actual dose of study drug.
Intention-to-treat population: all participants who received at least one dose of study drug in Part 1 or 2; those with missing data after backwards imputation were treated as nonresponders
Posted
Number
95% Confidence Interval
percentage of participants
24 weeks after last dose of study drug (Week 36 or 48 depending on treatment duration)
ID
Title
Description
OG000
Participants in Parts 1 and 2 of the Study
Participants in Parts 1 and 2 who were part of the ITT population (those who received at least one dose of study drug in Part 1 or Part 2)
OG001
Adult Tablet, 12-17 YR, ≥ 45 kg
Participants age 12-17 years old who received the adult formulation and weighed ≥ 45 kg
OG002
Mini-tablet, 9-11 YR, 15 to 29 kg
Participants age 9-11 years old who received the mini-tablet formulation and weighed 15 to 29 kg
Secondary
Parts 1 and 2: Percentage of Participants With Alanine Aminotransferase (ALT) Normalization During Treatment by Formulation, Age and Weight Group, Across All Subjects, and Across All Subjects on the Adult Formulations
Alanine aminotransferase (ALT) normalization during treatment is defined as ALT ≤ the upper limit of normal (ULN) at the final treatment visit for participants with ALT > ULN at baseline.
Intention-to-treat population including participants whose alanine aminotransferase (ALT) levels were > the upper limit of normal at baseline and who had available on-treatment ALT data
Posted
Number
95% Confidence Interval
percentage of participants
12 or 24 weeks after starting study drug, depending on treatment duration
ID
Title
Description
OG000
Adult Tablet,12-17 YR, ≥ 45 kg, ALT Normalization
Participants age 12-17 years old with alanine aminotransferase > upper limit of normal at baseline who received the adult formulation and weighed ≥ 45 kg
OG001
Mini-tablet, 9-11 YR, 15 to 29 kg, ALT Normalization
Participants age 9-11 years old with alanine aminotransferase > upper limit of normal at baseline who received the mini-tablet formulation and weighed 15 to 29 kg
OG002
Mini-tablet, 9-11 YR, 30 to 44 kg, ALT Normalization
Time Frame
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last dose, up to 37 weeks. SAEs and protocol-related nonserious AEs were collected from the time the subject signed consent.
Description
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
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
Adult Tablet, 12-17 yr, Part 1
Participants with HCV GT1b without cirrhosis received the adult 3-DAA (OBV/PTV/RTV and DSV) regimen: two 12.5 mg ombitasvir /75 mg paritaprevir /50 mg ritonavir tablets taken orally every morning (QD) and one dasabuvir 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis received 12-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label.
0
12
0
12
11
12
EG001
Adult Tablet, 12-17 yr, Part 2
Participants with HCV GT1b received the adult 3-DAA (OBV/PTV/RTV and DSV) regimen: two 12.5 mg ombitasvir /75mg paritaprevir /50 mg ritonavir tablets taken orally every morning (QD) and one dasabuvir 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis received 12-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label. Participants with HCV GT1a with compensated cirrhosis received 24-week treatment with the adult 3-DAA regimen and ribavirin 200 mg tablets were administered orally per local label. Participants with HCV GT4 received 12-week treatment with the OBV/PTV/RTV formulation and ribavirin 200 mg tablets were administered orally per local label.
0
26
0
26
17
26
EG002
Adult Tablet, 12-17 yr, Total
Participants age 12-17 years old who received at least one dose of the adult formulation
0
38
0
38
28
38
EG003
Mini Tablet, 9-11 yr, Part 1
Participants with HCV GT1b without cirrhosis were to receive the mini-tablet 3-DAA (OBV, PTV, RTV, and DSV) regimen for 12 weeks: ombitasvir 0.3 mg, paritaprevir 1.0 mg, and ritonavir 1.0 mg mini-tablets administered orally QD based on body weight and dasabuvir taken orally BID as 3.08 mg mini-tablets based on body weight. Participants with HCV GT1a without cirrhosis received 12-week treatment with the mini-tablet 3-DAA regimen and ribavirin was provided as a 40 mg/mL oral solution and administered per local label.
0
12
1
12
12
12
EG004
Mini Tablet, 3-8 yr, Part 1
Participants with HCV GT1b without cirrhosis were to receive the mini-tablet 3-DAA (OBV, PTV, RTV, and DSV) regimen for 12 weeks: ombitasvir 0.3 mg, paritaprevir 1.0 mg, and ritonavir 1.0 mg mini-tablets administered orally QD based on body weight and dasabuvir taken orally BID as 3.08 mg mini-tablets based on body weight. Participants with HCV GT1a without cirrhosis received 12-week treatment with the mini-tablet 3-DAA regimen and ribavirin was provided as a 40 mg/mL oral solution and administered per local label.
0
14
0
14
9
14
EG005
Mini Tablet, Total
Participants who received at least one dose of the mini-tablet formulation
0
26
1
26
21
26
EG006
All Participants, Total
All participants who received at least one dose of study drug in Part 1 or Part 2
0
64
1
64
49
64
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Leukopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected38 at risk
EG0031 events1 affected12 at risk
EG0040 events0 affected14 at risk
EG0051 events1 affected26 at risk
EG0061 events1 affected64 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected38 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0002 events1 affected12 at risk
EG0010 events0 affected26 at risk
EG0022 events1 affected38 at risk
EG0031 events1 affected12 at risk
EG0040 events0 affected14 at risk
EG0051 events1 affected26 at risk
EG0063 events2 affected64 at risk
Haemolysis
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected38 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected38 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected38 at risk
EG003
Atrioventricular block first degree
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected38 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected38 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected38 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected12 at risk
EG0010 events0 affected26 at risk
EG0022 events2 affected38 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected26 at risk
EG0021 events1 affected38 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected26 at risk
EG0021 events1 affected38 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected26 at risk
EG0021 events1 affected38 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected38 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected26 at risk
EG0021 events1 affected38 at risk
EG003
Lip ulceration
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected38 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected12 at risk
EG0010 events0 affected26 at risk
EG0023 events3 affected38 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected26 at risk
EG0021 events1 affected38 at risk
EG003
Chest discomfort
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected38 at risk
EG003
Chest pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0011 events1 affected26 at risk
EG0022 events2 affected38 at risk
EG003
Chills
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected38 at risk
EG003
Fatigue
General disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected12 at risk
EG0015 events5 affected26 at risk
EG0027 events7 affected38 at risk
EG003
Influenza like illness
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected38 at risk
EG003
Pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected38 at risk
EG003
Pyrexia
General disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected12 at risk
EG0011 events1 affected26 at risk
EG0023 events3 affected38 at risk
EG003
Vessel puncture site pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected38 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected38 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected38 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected38 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected26 at risk
EG0021 events1 affected38 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected38 at risk
EG003
Impetigo
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected26 at risk
EG0021 events1 affected38 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected26 at risk
EG0021 events1 affected38 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0015 events4 affected26 at risk
EG0026 events5 affected38 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected38 at risk
EG003
Otitis media
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected38 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected38 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected12 at risk
EG0010 events0 affected26 at risk
EG0022 events2 affected38 at risk
EG003
Streptococcal infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected38 at risk
EG003
Tracheitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected38 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0003 events2 affected12 at risk
EG0013 events2 affected26 at risk
EG0026 events4 affected38 at risk
EG003
Viral infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected38 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected38 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected38 at risk
EG003
Electrocardiogram abnormal
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected38 at risk
EG003
Electrocardiogram change
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected38 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected38 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0011 events1 affected26 at risk
EG0022 events2 affected38 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected38 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected38 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected38 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected38 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0011 events1 affected26 at risk
EG0022 events2 affected38 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0011 events1 affected26 at risk
EG0022 events2 affected38 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected38 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected38 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events2 affected26 at risk
EG0022 events2 affected38 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected12 at risk
EG0015 events5 affected26 at risk
EG0028 events8 affected38 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0002 events1 affected12 at risk
EG0010 events0 affected26 at risk
EG0022 events1 affected38 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected12 at risk
EG0010 events0 affected26 at risk
EG0022 events2 affected38 at risk
EG003
Behavioural insomnia of childhood
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected38 at risk
EG003
Depression
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected38 at risk
EG003
Mood swings
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected38 at risk
EG003
Nightmare
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected38 at risk
EG003
Sleep terror
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected38 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected38 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0013 events3 affected26 at risk
EG0023 events3 affected38 at risk
EG003
Pruritus genital
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected38 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events2 affected26 at risk
EG0022 events2 affected38 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected38 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0013 events1 affected26 at risk
EG0023 events1 affected38 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected38 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected12 at risk
EG0011 events1 affected26 at risk
EG0023 events3 affected38 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected38 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected38 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected38 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0014 events4 affected26 at risk
EG0025 events5 affected38 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected38 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected38 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
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
According to the Highlights of Prescribing Information of PEGASYS, the SVR24 rate was 47% among 45 treatment-naïve pediatric participants with HCV GT1 in the NV17424 trial. To show that the DAA regimen is superior to this current standard of care by 20%, the lower bound of the 2-sided 95% confidence interval of the SVR12 rate across all participants in the study must be greater than 67%.
Wilson's score method
98.4
2-Sided
95
91.7
99.7
Superiority
OG003
Mini-tablet, 9-11 YR, ≥ 45 kg
Participants age 9-11 years old who received the mini-tablet formulation and weighed ≥ 45 kg
OG004
Mini-tablet, 3-8 YR, 15 to 29 kg
Participants age 3-8 years old who received the mini-tablet formulation and weighed 15 to 29 kg
OG005
Mini-tablet Total
All participants who received the mini-tablet formulation
Units
Counts
Participants
OG00038
OG0011
OG0029
OG0032
OG00414
OG00526
Title
Denominators
Categories
Title
Measurements
OG000100(90.8 to 100.0)
OG001100(20.7 to 100.0)
OG002100(70.1 to 100.0)
OG003100(34.2 to 100.0)
OG00492.9(68.5 to 98.7)
OG00596.2(81.1 to 99.3)
OG003
Mini-tablet, 9-11 YR, 30 to 44 kg
Participants age 9-11 years old who received the mini-tablet formulation and weighed 30 to 44 kg
OG004
Mini-tablet, 9-11 YR, ≥ 45 kg
Participants age 9-11 years old who received the mini-tablet formulation and weighed ≥ 45 kg
OG005
Mini-tablet, 3-8 YR, 15 to 29 kg
Participants age 3-8 years old who received the mini-tablet formulation and weighed 15 to 29 kg
OG006
Mini-tablet Total
All participants who received the mini-tablet formulation
Units
Counts
Participants
OG00064
OG00138
OG0021
OG0039
OG0042
OG00514
OG00626
Title
Denominators
Categories
Title
Measurements
OG00096.9(89.3 to 99.1)
OG001100(90.8 to 100.0)
OG002100.0(20.7 to 100.0)
OG00388.9(56.5 to 98.0)
OG004100.0(34.2 to 100.0)
OG00592.9(68.5 to 98.7)
OG00692.3(75.9 to 97.9)
Participants age 9-11 years old with alanine aminotransferase > upper limit of normal at baseline who received the mini-tablet formulation and weighed 30 to 44 kg
OG003
Mini-tablet, 3-8 YR, 15 to 29 kg, ALT Normalization
Participants age 3-8 years old with alanine aminotransferase > upper limit of normal at baseline who received the mini-tablet formulation and weighed 15 to 29 kg
OG004
Mini-tablet Total, ALT Normalization
All participants with alanine aminotransferase > upper limit of normal at baseline who received the mini-tablet formulation
OG005
Participants in Parts 1 and 2 of the Study, ALT Normalization
All participants with alanine aminotransferase > upper limit of normal at baseline