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

Primary Purpose

HCV Related Cirrhosis

Status
Terminated
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Sofosbuvir + Ribavirin 1
Sofosbuvir + Ribavirin 2
Sofosbuvir + Ribavirin 3
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HCV Related Cirrhosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Liver and Biliary Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Sofosbuvir + Ribavirin 1

Sofosbuvir + Ribavirin 2

Sofosbuvir + Ribavirin 3

Arm Description

Sofosbuvir + Ribavirin x 24 weeks

Sofosbuvir + Ribavirin x 36 weeks

Sofosbuvir + Ribavirin x 48 weeks

Outcomes

Primary Outcome Measures

The Primary efficacy end point is SVR 24 defined as HCV RNA <LLOQ (lower limit of quantification)

Secondary Outcome Measures

The secondary endpoint is any AE (Adverse Event) leading to permanent discontinuation of study drugs.
Mortality at 6 months post therapy in all the 3 groups.
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.
Number of new cases of Hepatocellular Carcinoma at end of therapy and at 6 months post therapy in all the 3 groups.
Reduction in HVPG >20% to baseline after 1 year in all the 3 groups.
SVR 4 defined as HCV RNA <LLOQ (lower limit of quantification)
SVR 12 defined as HCV RNA <LLOQ (lower limit of quantification)

Full Information

First Posted
May 22, 2015
Last Updated
January 18, 2017
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT02464631
Brief Title
To Evaluate the Safety and Efficacy of Sofosbuvir and Ribavirin in Patients With HCV (Genotype 3) Related Decompensated Cirrhosis
Official Title
To Evaluate the Safety and Efficacy of Sofosbuvir and Ribavirin in Patients With HCV (Genotype 3) Related Decompensated Cirrhosis" - A Randomized Open- Label Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
In view of recent approval of NS5A inhibitors for treatment of hepatitis C such as Declatasvir and Ledipasvir which have proven better efficacy in the HCV cure
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HCV Related Cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sofosbuvir + Ribavirin 1
Arm Type
Active Comparator
Arm Description
Sofosbuvir + Ribavirin x 24 weeks
Arm Title
Sofosbuvir + Ribavirin 2
Arm Type
Experimental
Arm Description
Sofosbuvir + Ribavirin x 36 weeks
Arm Title
Sofosbuvir + Ribavirin 3
Arm Type
Experimental
Arm Description
Sofosbuvir + Ribavirin x 48 weeks
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir + Ribavirin 1
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir + Ribavirin 2
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir + Ribavirin 3
Primary Outcome Measure Information:
Title
The Primary efficacy end point is SVR 24 defined as HCV RNA <LLOQ (lower limit of quantification)
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
The secondary endpoint is any AE (Adverse Event) leading to permanent discontinuation of study drugs.
Time Frame
3 years
Title
Mortality at 6 months post therapy in all the 3 groups.
Time Frame
48 weeks
Title
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
Title
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
Title
Reduction in HVPG >20% to baseline after 1 year in all the 3 groups.
Time Frame
48 weeks
Title
SVR 4 defined as HCV RNA <LLOQ (lower limit of quantification)
Time Frame
24 weeks
Title
SVR 12 defined as HCV RNA <LLOQ (lower limit of quantification)
Time Frame
36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ankur Jindal, DM
Organizational Affiliation
Institute of Liver and Biliary Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India

12. IPD Sharing Statement

Learn more about this trial

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

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