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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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HCV Related Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sofosbuvir + Ribavirin 1

Sofosbuvir + Ribavirin x 24 weeks

Group Type ACTIVE_COMPARATOR

Sofosbuvir + Ribavirin 1

Intervention Type DRUG

Sofosbuvir + Ribavirin 2

Sofosbuvir + Ribavirin x 36 weeks

Group Type EXPERIMENTAL

Sofosbuvir + Ribavirin 2

Intervention Type DRUG

Sofosbuvir + Ribavirin 3

Sofosbuvir + Ribavirin x 48 weeks

Group Type EXPERIMENTAL

Sofosbuvir + Ribavirin 3

Intervention Type DRUG

Interventions

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Sofosbuvir + Ribavirin 1

Intervention Type DRUG

Sofosbuvir + Ribavirin 2

Intervention Type DRUG

Sofosbuvir + Ribavirin 3

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No