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

Cirrhosis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02442284
• Other study ID #: M14-251
• Status: Completed
• Phase: Phase 3
• First received: May 11, 2015
• Last updated: September 14, 2017
• Start date: May 13, 2015
• Est. completion date: October 31, 2016

Study information

• Verified date: September 2017
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: October 31, 2016
• Est. primary completion date: August 22, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Cirrhosis
• Fibrosis
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• ombitasvir/paritaprevir/ritonavir and dasabuvir
Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet
• Ribavirin
Tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 [	12 weeks after the last actual dose of study drug
Secondary	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.	up to 12 weeks (for 12-week treatment group) or up to 24 weeks (for 24-week treatment group
Secondary	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.	From the end of treatment through 12 weeks after the last dose of study drug
Secondary	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 [	12 weeks after the last actual dose of study drug

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