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

• Status: Unknown status
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tel-Aviv Sourasky Medical Center
• Treatments: Protease Inhibitors; Ribavirin; Ritonavir

Criteria

Inclusion Criteria:

• Diagnosis of hepatitis C, genotype 1A or 1B.

• Documentation of PI failure of treatment at least 12 months prior to study entry.

• Patients with cirrhosis - (only patients with cirrhosis Child A with only 5 points).

Exclusion Criteria:

• Inability to stay in the study for 36 weeks.

• Diagnosis of cross-contamination by HIV or Hepatitis B virus.

• Renal disfunction (creatinine clearance <30 ml / min).

• Evidence of hepatic carcinoma.

• Another serious disease, which may interfere with the study.

• Pregnant / breast-feeding women.

• Men with pregnant partners.

• Drug or alcohol abuse in the six months preceding the study.

• Chronic liver disease other than hepatitis C (such as Primary biliary cirrhosis, Primary sclerosing cholangitis, Autoimmune hepatitis).

• Current other treatment for HCV.

• Past PI Failure due to adverse events.

• Patients with cirrhosis Child B.

• Patients with cirrhosis, who were at child B and improved to child A after treatment.