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

Not Applicable

Terminated

• Conditions: HCV Related Cirrhosis
• Interventions: Drug: Sofosbuvir + Ribavirin 1; Drug: Sofosbuvir + Ribavirin 3; Drug: Sofosbuvir + Ribavirin 2

• Registration Number: NCT02464631
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-22
• Study Start: 2015-06
• Study First Submitted QC: 2015-06-03
• Study First Posted: 2015-06-08
• Status Verified: 2016-01
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-01-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sofosbuvir + Ribavirin 1	Sofosbuvir + Ribavirin 1	Sofosbuvir + Ribavirin x 24 weeks
Sofosbuvir + Ribavirin 3	Sofosbuvir + Ribavirin 3	Sofosbuvir + Ribavirin x 48 weeks
Sofosbuvir + Ribavirin 2	Sofosbuvir + Ribavirin 2	Sofosbuvir + Ribavirin x 36 weeks

Primary Outcome Measures

Name	Time	Method
The Primary efficacy end point is SVR 24 defined as HCV RNA <LLOQ (lower limit of quantification)	48 weeks

Secondary Outcome Measures

Name	Time	Method
Mortality at 6 months post therapy in all the 3 groups.	48 weeks
Reduction in HVPG >20% to baseline after 1 year in all the 3 groups.	48 weeks
SVR 12 defined as HCV RNA <LLOQ (lower limit of quantification)	36 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.	48 weeks
SVR 4 defined as HCV RNA <LLOQ (lower limit of quantification)	24 weeks
The secondary endpoint is any AE (Adverse Event) leading to permanent discontinuation of study drugs.	3 years
Number of new cases of Hepatocellular Carcinoma at end of therapy and at 6 months post therapy in all the 3 groups.	48 weeks

Trial Locations

Locations (1)

Institute of Liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India