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Completed

NCT Number: NCT02442284

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

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.

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Cirrhosis Communicable Diseases Digestive System Diseases Disease Attributes Fibrosis Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C Virus Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ombitasvir/paritaprevir/ritonavir and dasabuvir

Drug

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

Other names: Viekira Pak, paritaprevir also known as ABT-450, ombitasvir also known as ABT-267, dasabuvir also known as ABT-333

Ribavirin

Drug

Tablet

Primary outcomes

  1. 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 [<LLOQ]) 12 weeks after the last dose of study drug. Participants with missing data after backwards imputation were imputed as nonresponders.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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 [<LLOQ]) 12 weeks after the last dose of study drug. Participants with missing data after backwards imputation were imputed as nonresponders.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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)

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 13, 2015
Registry last updated
Oct 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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