To Evaluate the Safety and Efficacy of Sofosbuvir and Ribavirin in Patients With HCV (Genotype 3) Related Decompensated Cirrhosis

January 18, 2017 updated by: Institute of Liver and Biliary Sciences, India

To Evaluate the Safety and Efficacy of Sofosbuvir and Ribavirin in Patients With HCV (Genotype 3) Related Decompensated Cirrhosis" - A Randomized Open- Label Study

In this prospective randomized trial, A Minimum of 300 consecutive patients of decompensated HCV (Hepatitis C Virus) related cirrhosis, presenting to the Institute of Liver and Biliary Sciences hospital will be included and those patients meeting the entry criteria received treatment with 400 mg of Sofosbuvir, administered orally once daily, and Ribavirin administered orally twice daily, with doses determined according to body weight(600 mg daily in patients with a body weight of ≤60 kg,800 mg daily in patients weighing >60 and ≤80 kg, and1000 mg daily in patients with a body weight of >80 kg). Based on the treatment duration, patients would be randomized in either of the 3 treatment groups -

  • Group 1 - Sofosbuvir + Ribavirin x 24 weeks
  • Group 2 - Sofosbuvir + Ribavirin x 36 weeks
  • Group 3 - Sofosbuvir + Ribavirin x 48 weeks

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110070
        • Institute of liver and Biliary Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or Female ≥ 18 yrs
  • Baseline HCV RNA > 1000 IU/ml
  • Cirrhosis with current or prior decompensation
  • HCV (Hepatitis C Infection) Genotype 3
  • Treatment naïve or treatment experienced

Exclusion Criteria:

  • HIV or HBV (Hepatitis B Virus) co-infection
  • Recent Variceal bleed
  • Pregnancy
  • Haemolytic anaemia
  • Platelet counts <20,000/ml
  • Advanced HCC (Hepatocellular Carcinoma)
  • Renal dysfunction, GFR (glomerular filtration rate) < 30 ml/min
  • Haemoglobin < 10 g/dl
  • MELD (Model for End Stage Liver Disease) >25, CTP (Child-Turcotte-Pugh score) >12
  • Post organ transplant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sofosbuvir + Ribavirin 1
Sofosbuvir + Ribavirin x 24 weeks
Drug: Sofosbuvir + Ribavirin 1
Experimental: Sofosbuvir + Ribavirin 2
Sofosbuvir + Ribavirin x 36 weeks
Drug: Sofosbuvir + Ribavirin 2
Experimental: Sofosbuvir + Ribavirin 3
Sofosbuvir + Ribavirin x 48 weeks
Drug: Sofosbuvir + Ribavirin 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Primary efficacy end point is SVR 24 defined as HCV RNA <LLOQ (lower limit of quantification)
Time Frame: 48 weeks
48 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The secondary endpoint is any AE (Adverse Event) leading to permanent discontinuation of study drugs.
Time Frame: 3 years
3 years
Mortality at 6 months post therapy in all the 3 groups.
Time Frame: 48 weeks
48 weeks
Improvement in the liver function as determined by CTP (Child-Turcotte-Pugh score), MELD (Model for End Stage liver Disease)more than 2 points at 6 months and 1 year.
Time Frame: 48 weeks
48 weeks
Number of new cases of Hepatocellular Carcinoma at end of therapy and at 6 months post therapy in all the 3 groups.
Time Frame: 48 weeks
48 weeks
Reduction in HVPG >20% to baseline after 1 year in all the 3 groups.
Time Frame: 48 weeks
48 weeks
SVR 4 defined as HCV RNA <LLOQ (lower limit of quantification)
Time Frame: 24 weeks
24 weeks
SVR 12 defined as HCV RNA <LLOQ (lower limit of quantification)
Time Frame: 36 weeks
36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Liver and Biliary Sciences, India

Investigators

  • Principal Investigator: Ankur Jindal, DM, Institute of liver and Biliary Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

May 22, 2015

First Submitted That Met QC Criteria

June 3, 2015

First Posted (Estimate)

June 8, 2015

Study Record Updates

Last Update Posted (Estimate)

January 19, 2017

Last Update Submitted That Met QC Criteria

January 18, 2017

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILBS-HCV-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HCV Related Cirrhosis

Clinical Trials on Sofosbuvir + Ribavirin 1

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe