A Study of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Sofosbuvir and Ribavirin in Direct-Acting Antiviral Agent Treatment-Experienced Adults With Chronic Hepatitis C Virus Infection

Chronic Hepatitis C Infection Clinical Trial

Official title:

An Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) and Dasabuvir Co-administered With or Without Sofosbuvir (SOF) and Ribavirin (RBV) in Direct-Acting Antiviral Agent (DAA) Treatment-Experienced Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02356562
• Other study ID #: M14-224
• Status: Completed
• Phase: Phase 2
• First received: February 2, 2015
• Last updated: November 22, 2017
• Start date: February 3, 2015
• Est. completion date: July 7, 2017

Study information

• Verified date: October 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 sofosbuvir (SOF) and ribavirin (RBV) in DAA treatment-experienced adults with Genotype 1 Chronic Hepatitis C Virus infection. This study will contain 2 parts.

Part 1: Approximately 20 participants and at least 10 of the 20 participants previously treated with the combination of ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without RBV, and experienced treatment failure.

Part 2: Approximately 10 participants and all participants previously treated with SOF/ledipasvir and experienced treatment failure.

Description:

Efficacy, safety, and demographic analyses were performed separately for the 2 study parts using the intent-to-treat (ITT) population, which consists of all enrolled participants who received at least one dose of study drug.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: July 7, 2017
• Est. primary completion date: October 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• History of previous direct acting antiviral (DAA) therapy failure; Part 2 only:

history of previous direct acting antiviral (DAA) therapy failure and received at least 8 weeks of SOF/ledipasvir; participant must be treatment naïve to all other anti-HCV therapies

• HCV genotype 1 infection

• Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control

Exclusion Criteria:

• Positive screen for hepatitis B surface antigen or anti-human immunodeficiency virus antibody

• Discontinuation of the prior DAA treatment for reasons other than virologic failure

• Confirmed presence of hepatocellular carcinoma

• Abnormal lab tests

Related Conditions & MeSH terms

• Chronic Hepatitis C Infection
• Communicable Diseases
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Infection

Intervention

Drug:
• ombitasvir/paritaprevir/ritonavir and dasabuvir
tablet, ombitasvir coformulated with paritaprevir and ritonavir; tablet, dasabuvir
• Sofosbuvir
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 Part 1 Participants With Sustained Virologic Response 12 (SVR12) Weeks Posttreatment	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 dose of active drug
Secondary	Percentage of Part 2 Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment	SVR12 was defined as plasma HCV RNA level	12 weeks after the last dose of active drug
Secondary	Percentage of Participants With On-treatment Virologic Failure	On-treatment virologic failure was defined as confirmed HCV RNA = LLOQ after < LLOQ during treatment, confirmed increase of > 1 log (subscript)10(subscript) IU/mL above the lowest post-baseline HCV RNA during treatment, or HCV RNA = LLOQ persistently during treatment with at least 6 weeks of treatment.	Up to week 24
Secondary	Percentage of Participants With Post-Treatment Relapse	Post-treatment relapse was defined as confirmed HCV RNA = LLOQ between end of treatment and 12 weeks after the last dose of study drug among participants completing treatment and with HCV RNA < LLOQ at the end of treatment.	Within 12 weeks after the last actual dose of active study drug