A Study to Evaluate Chronic Hepatitis C Virus (HCV) Infection in Cirrhotic Adults With Genotype 1b (GT1b) Infection

NCT ID: NCT02216422

Last Updated: 2016-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-12-31

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.

Conditions

Chronic Hepatitis C Virus (HCV) Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir with RBV

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

Group Type: EXPERIMENTAL

Ombitasvir/Paritaprevir/Ritonavir

Intervention Type: DRUG

Tablet; paritaprevir co-formulated with ritonavir and ombitasvir

Dasabuvir

Intervention Type: DRUG

Tablet

Ribavirin (RBV)

Intervention Type: DRUG

Tablet

Interventions

Ombitasvir/Paritaprevir/Ritonavir

Tablet; paritaprevir co-formulated with ritonavir and ombitasvir

Intervention Type: DRUG

Dasabuvir

Tablet

Intervention Type: DRUG

Ribavirin (RBV)

Tablet

Intervention Type: DRUG

Other Intervention Names

ABT-267 also known as ombitasvir; ABT-450 also known as paritaprevir; Ritonavir also known as norvir; ABT-333

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rolando M Viani, MD

Role: STUDY_DIRECTOR

AbbVie

Related Links

http://www.rxabbvie.com/

Related Info

Other Identifiers

M14-252

Identifier Type: -

Identifier Source: org_study_id