Clinical Trials

MainTitle

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

This study has been completed
Sponsor
AbbVie


Information provided by (Responsible Party)
AbbVie
ClinicalTrials.gov Identifier
NCT02442284

First received: May 11, 2015
Last updated: September 14, 2017
Last Verified: September 2017
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
Chronic Hepatitis C
Cirrhosis
Hepatitis C Virus

Drug : ombitasvir/paritaprevir/ritonavir and dasabuvir
Drug : Ribavirin
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Further study details as provided by AbbVie:

Primary Outcome Measures

  • Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [ Time Frame: 12 weeks after the last actual dose of study drug ]
    SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [
Secondary Outcome Measures:
  • Percentage of Participants With Virologic Failure During Treatment [ Time Frame: up to 12 weeks (for 12-week treatment group) or up to 24 weeks (for 24-week treatment group ]
    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 [ Time Frame: From the end of treatment through 12 weeks after the last dose of study drug ]
    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 [ Time Frame: 12 weeks after the last actual dose of study drug ]
    SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [

Enrollment: 99
Study Start Date: May 13, 2015
Study Completion Date: October 31, 2016
Primary Completion Date: August 22, 2016 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: 3-DAA ± RBV for 12 or 24 weeks
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.
Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

Other Name:
  • Viekira Pak
  • paritaprevir also known as ABT-450
  • ombitasvir also known as ABT-267
  • dasabuvir also known as ABT-333

Drug: Ribavirin

Tablet

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02442284

Sponsors and Collaborators

AbbVie

Investigators

Study Director: AbbVie Inc. AbbVie
More Information

More Information

Additional Information:

Related Info

Responsible Party: AbbVie  
ClinicalTrials.gov Identifier: NCT02442284   History of Changes  
Other Study ID Numbers: M14-251  
Study First Received: May 11, 2015  
Last Updated: September 14, 2017  

Keywords provided by AbbVie:

Chronic Hepatitis C
Interferon-Free
Hepatitis C Genotype 1
Hepatitis C Virus
Hepatitis C
Cirrhosis

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Fibrosis
Hepatitis C, Chronic
Ribavirin
Ritonavir

ClinicalTrials.gov processed this data on December 08, 2017
This information is provided by ClinicalTrials.gov.