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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02646111
• Other study ID #: TASMC-15-OS-503-CTIL
• Status: Not yet recruiting
• Phase: Phase 3
• First received: December 28, 2015
• Last updated: January 4, 2016
• Start date: January 2016
• Est. completion date: January 2019

Study information

• Verified date: January 2016
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Oren Shibolet, MD
• Phone: 97236973984
• Email: orensh[@]tlvmc.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: January 2019
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

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

Intervention

Drug:
• 12 weeks without Ribavirin
12 weeks Triple Therapy: Ombitasvir, Paritaprevir, Ritonavir (25/150/100 mg dose) once daily and Dasabuvir 250 mg twice daily.
• 12 weeks with Ribavirin
12 weeks Triple Therapy: Ombitasvir, Paritaprevir, Ritonavir 25/150/100 mg dose once daily + Dasabuvir 250 mg twice daily + weight adjusted Ribavirin, daily dose: 1,000 mg weight <75 kg, 1,200 mg weight> 75 kg.
• 24 weeks with Ribavirin
24 weeks Triple Therapy: Ombitasvir, Paritaprevir, Ritonavir 25/150/100 mg dose once daily + Dasabuvir 250 mg twice daily + weight adjusted Ribavirin, daily dose: 1,000 mg weight <75 kg, 1,200 mg weight> 75 kg.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"SVR" (sustained virologic response) rates	Sustained virologic response	12 weeks after end of treatment	No
Secondary	"SF" (short-form)-36 health survey	psychometrically-based physical and mental health and a preference-based health utility index.	Day 1, weeks 4, 12, 24, 36.	No
Secondary	WPAI Hep C v2.0 questionnaire	a scoring manual for work productivity and activity impairment assessment.	Day 1, weeks 4, 12, 24, 36.	No