Back to resultsA Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in US Veterans With Genotype 1 Chronic Hepatitis C Virus Infection
Primary Purpose
Chronic Hepatitis C, Cirrhosis, Hepatitis C Virus
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ombitasvir/paritaprevir/ritonavir and dasabuvir
Ribavirin
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Chronic Hepatitis C, Interferon-Free, Hepatitis C Genotype 1, Hepatitis C Virus, Hepatitis C, Cirrhosis
Eligibility Criteria
Inclusion Criteria:
- US military veteran currently receiving healthcare through the Veterans Health Administration
- Screening laboratory result indicating hepatitis C virus (HCV), genotype 1-infection
- Positive for hepatitis C antibodies or HCV RNA at least 6 months before Screening, and HCV RNA > 1,000 IU/mL at the time of Screening or HCV RNA > 1,000 IU/mL at the time of Screening with a liver biopsy consistent with chronic HCV-infection (or a liver biopsy performed prior to enrollment with evidence of chronic hepatitis C disease)
Exclusion Criteria:
- Women who are pregnant or breastfeeding
- Positive test result for hepatitis B surface antigen (HbsAg) or anti-HIV antibodies (HIV Ab)
- Prior or current use of any investigational or commercially available anti-HCV agents other than IFN, pegIFN, RBV or sofosbuvir
- Any current or past clinical evidence of Child-Pugh B or C classification
- Confirmed presence of hepatocellular carcinoma indicated on imaging techniques within 3 months prior to Screening or on an ultrasound performed at Screening for participants with cirrhosis
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
3-DAA ± RBV for 12 or 24 weeks
Arm Description
3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis.
Outcomes
Primary Outcome Measures
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. Participants with missing data after backwards imputation were imputed as nonresponders.
Secondary Outcome Measures
Percentage of Participants With Virologic Failure During Treatment
On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment.
Percentage of Participants With Post-treatment Relapse
Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) Among Participants With Ongoing Psychiatric Disorders
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. Participants with missing data after backwards imputation were imputed as nonresponders.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02442284
Brief Title
A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in US Veterans With Genotype 1 Chronic Hepatitis C Virus Infection
Official Title
An Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin (RBV) in US Veterans With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ-VA)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
May 13, 2015 (Actual)
Primary Completion Date
August 22, 2016 (Actual)
Study Completion Date
October 31, 2016 (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
The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in US veterans with genotype 1 chronic hepatitis C virus infection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C, Cirrhosis, Hepatitis C Virus
Keywords
Chronic Hepatitis C, Interferon-Free, Hepatitis C Genotype 1, Hepatitis C Virus, Hepatitis C, Cirrhosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3-DAA ± RBV for 12 or 24 weeks
Arm Type
Experimental
Arm Description
3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis.
Intervention Type
Drug
Intervention Name(s)
ombitasvir/paritaprevir/ritonavir and dasabuvir
Other Intervention Name(s)
Viekira Pak, paritaprevir also known as ABT-450, ombitasvir also known as ABT-267, dasabuvir also known as ABT-333
Intervention Description
Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
Tablet
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Description
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. Participants with missing data after backwards imputation were imputed as nonresponders.
Time Frame
12 weeks after the last actual dose of study drug
Secondary Outcome Measure Information:
Title
Percentage of Participants With Virologic Failure During Treatment
Description
On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment.
Time Frame
up to 12 weeks (for 12-week treatment group) or up to 24 weeks (for 24-week treatment group
Title
Percentage of Participants With Post-treatment Relapse
Description
Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.
Time Frame
From the end of treatment through 12 weeks after the last dose of study drug
Title
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) Among Participants With Ongoing Psychiatric Disorders
Description
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. Participants with missing data after backwards imputation were imputed as nonresponders.
Time Frame
12 weeks after the last actual dose of study drug
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
US military veteran currently receiving healthcare through the Veterans Health Administration
Screening laboratory result indicating hepatitis C virus (HCV), genotype 1-infection
Positive for hepatitis C antibodies or HCV RNA at least 6 months before Screening, and HCV RNA > 1,000 IU/mL at the time of Screening or HCV RNA > 1,000 IU/mL at the time of Screening with a liver biopsy consistent with chronic HCV-infection (or a liver biopsy performed prior to enrollment with evidence of chronic hepatitis C disease)
Exclusion Criteria:
Women who are pregnant or breastfeeding
Positive test result for hepatitis B surface antigen (HbsAg) or anti-HIV antibodies (HIV Ab)
Prior or current use of any investigational or commercially available anti-HCV agents other than IFN, pegIFN, RBV or sofosbuvir
Any current or past clinical evidence of Child-Pugh B or C classification
Confirmed presence of hepatocellular carcinoma indicated on imaging techniques within 3 months prior to Screening or on an ultrasound performed at Screening for participants with cirrhosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://rxabbvie.com
Description
Related Info
Learn more about this trial
A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in US Veterans With Genotype 1 Chronic Hepatitis C Virus Infection
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