Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With and Without Ribavirin in Protease-Inhibitors ("PI") Failures

Hepatitis C Clinical Trial

Official title: An Open-label, Multi-center Study to Evaluate Sustained Virologic Response With Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With and Without Ribavirin in Genotype 1 Chronic Hepatitis C Virus Infected Patients With Past PI Failure

Status Not yet recruiting

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of triple therapy of AbbVie adults with chronic hepatitis C virus ("HCV"), who have not responded to prior treatment with protease inhibitors.

The "Triple therapy" of AbbVie attacks various sites of the viral genome, thus increasing the potential efficacy of the treatment, especially for patients who have failed PI treatment.

Clinical Trial Description

Patients with genotype 1 HCV, who underwent past triple therapy (Telaprevir, Boceprevir or Simeprevir with Pegylated interferon / Ribavirin) and are non-responders, partial responders or in relapse - will be screened in all research centers up to 30 days before the first treatment.

At the end of the initial assessment - the recruited participants will be allocated to different treatment groups in accordance with the hepatitis virus subtype 1a, 1b and presence of cirrhosis, as follows:

• Group A - genotype 1b without cirrhosis - 12 weeks of treatment *

• Group B - genotype 1b with cirrhosis - 12 weeks of treatment

• Group C - genotype 1a without cirrhosis - 12 weeks of treatment

• Group D - genotype 1a with cirrhosis - 24 weeks of treatment

(* Only this group will not get Ribavirin)

During the treatment period, participants will be asked to describe the treatment's tolerability (in terms of side effects) using self-administered questionnaires: SF-36, and WPAI Hep C v2.0.

The follow up will also include physical assessments, side effects documentation, blood tests, abdominal Ultrasound and Fibroscan. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C

• NCT number: NCT02646111
• Study type: Interventional
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Oren Shibolet, MD
• Phone: 97236973984
• Email: orensh@tlvmc.gov.il
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: January 2016
• Completion date: January 2019