Back to resultsA Study to Evaluate Chronic Hepatitis C Virus (HCV) Infection in Cirrhotic Adults With Genotype 1b (GT1b) Infection (Turquoise-IV)
Primary Purpose
Chronic Hepatitis C Virus (HCV) Infection
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Ombitasvir/Paritaprevir/Ritonavir
Dasabuvir
Ribavirin (RBV)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C Virus (HCV) Infection focused on measuring Chronic Hepatitis C, Hepatitis C, Hepatitis C Virus, Hepatitis C Genotype 1b, Interferon-Free
Eligibility Criteria
Inclusion Criteria:
- Chronic hepatitis C, genotype 1b-infection (HCV RNA level greater than 1,000 IU/mL at Screening)
- Evidence of liver cirrhosis as confirmed by liver biopsy or Fibroscan with Child-Pugh score less than or equal to 6 at Screening
- Participant had never received antiviral treatment (including pegIFN/RBV) for hepatitis C infection (treatment-naïve participant) or had documentation of meeting one of the defined categories of a treatment-experienced participants
- Absence of hepatocellular carcinoma (HCC) as indicated by a negative ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI) performed within 3 months prior to screening or a negative ultrasound at screening.
- Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control
- Males must have been surgically sterile, or agreed to practice 2 effective methods of birth control throughout the course of the study.
Exclusion Criteria:
- Positive screen for hepatitis B Surface antigen or anti-Human Immunodeficiency virus antibody
- Evidence of current or past Child-Pugh B or C classification
- Confirmed presence of hepatocellular carcinoma
- Abnormal laboratory tests
- Participant who self-reported on average drinking more than 2 drinks per day for current drinkers
- Previous treatment with a direct acting antiviral agent (DAA) containing regimen
- History of solid organ transplant.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir with RBV
Arm Description
Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks
Outcomes
Primary Outcome Measures
Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment
Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug. Participants with missing data were imputed as failures.
Secondary Outcome Measures
Percentage of Participants With On-Treatment Virologic Failure
On-Treatment Virologic Failure is defined as confirmed HCV RNA >= LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir (local minimum value) in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above nadir] at any time point during treatment, or failure to suppress during treatment [all on-treatment values of HCV RNA >= LLOQ] with at least 6 weeks [defined as active study drug duration ≥ 36 days] of treatment.
Percentage of Participants With Post-Treatment Relapse
Post- Treatment Relapse is defined as confirmed HCV RNA >= LLOQ between end of treatment and 12 weeks after last actual dose of active study drug [up to and including the SVR12 assessment time point] for a participant with HCV RNA < LLOQ at Final Treatment Visit who completes treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02216422
Brief Title
A Study to Evaluate Chronic Hepatitis C Virus (HCV) Infection in Cirrhotic Adults With Genotype 1b (GT1b) Infection
Acronym
Turquoise-IV
Official Title
An Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered With Ribavirin (RBV) in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (Turquoise-IV)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This was a multicenter study evaluating the efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with ribavirin (RBV) for 12 weeks in treatment naïve and pegylated-interferon alfa-2a or alfa-2b (pegIFN)/RBV treatment-experienced, cirrhotic HCV genotype 1b-infected adults.
Detailed Description
The primary objective of this study was to assess the safety and efficacy (the percentage of participants achieving a 12-week sustained virologic response (SVR12), [HCV ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks following treatment]) of co-formulated ombitasvir, paritaprevir, and ritonavir (ombitasvir/paritaprevir/r) and dasabuvir co-administered with RBV for 12 weeks in HCV genotype 1b-infected adult participants with compensated cirrhosis. The secondary objectives of this study were to assess the number and percentage of participants with virologic failure during treatment and the percentage of participants with relapse post-treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C Virus (HCV) Infection
Keywords
Chronic Hepatitis C, Hepatitis C, Hepatitis C Virus, Hepatitis C Genotype 1b, Interferon-Free
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir with RBV
Arm Type
Experimental
Arm Description
Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Ombitasvir/Paritaprevir/Ritonavir
Other Intervention Name(s)
ABT-267 also known as ombitasvir, ABT-450 also known as paritaprevir, Ritonavir also known as norvir
Intervention Description
Tablet; paritaprevir co-formulated with ritonavir and ombitasvir
Intervention Type
Drug
Intervention Name(s)
Dasabuvir
Other Intervention Name(s)
ABT-333
Intervention Description
Tablet
Intervention Type
Drug
Intervention Name(s)
Ribavirin (RBV)
Intervention Description
Tablet
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment
Description
Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug. Participants with missing data were imputed as failures.
Time Frame
Post-treatment Day 1 to Post-treatment Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants With On-Treatment Virologic Failure
Description
On-Treatment Virologic Failure is defined as confirmed HCV RNA >= LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir (local minimum value) in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above nadir] at any time point during treatment, or failure to suppress during treatment [all on-treatment values of HCV RNA >= LLOQ] with at least 6 weeks [defined as active study drug duration ≥ 36 days] of treatment.
Time Frame
Day 1 through Week 12
Title
Percentage of Participants With Post-Treatment Relapse
Description
Post- Treatment Relapse is defined as confirmed HCV RNA >= LLOQ between end of treatment and 12 weeks after last actual dose of active study drug [up to and including the SVR12 assessment time point] for a participant with HCV RNA < LLOQ at Final Treatment Visit who completes treatment.
Time Frame
Post-treatment Day 1 to Post-treatment Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic hepatitis C, genotype 1b-infection (HCV RNA level greater than 1,000 IU/mL at Screening)
Evidence of liver cirrhosis as confirmed by liver biopsy or Fibroscan with Child-Pugh score less than or equal to 6 at Screening
Participant had never received antiviral treatment (including pegIFN/RBV) for hepatitis C infection (treatment-naïve participant) or had documentation of meeting one of the defined categories of a treatment-experienced participants
Absence of hepatocellular carcinoma (HCC) as indicated by a negative ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI) performed within 3 months prior to screening or a negative ultrasound at screening.
Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control
Males must have been surgically sterile, or agreed to practice 2 effective methods of birth control throughout the course of the study.
Exclusion Criteria:
Positive screen for hepatitis B Surface antigen or anti-Human Immunodeficiency virus antibody
Evidence of current or past Child-Pugh B or C classification
Confirmed presence of hepatocellular carcinoma
Abnormal laboratory tests
Participant who self-reported on average drinking more than 2 drinks per day for current drinkers
Previous treatment with a direct acting antiviral agent (DAA) containing regimen
History of solid organ transplant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rolando M Viani, MD
Organizational Affiliation
AbbVie
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://www.rxabbvie.com/
Description
Related Info
Learn more about this trial
A Study to Evaluate Chronic Hepatitis C Virus (HCV) Infection in Cirrhotic Adults With Genotype 1b (GT1b) Infection
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