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

NCT02464631 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2017-01-19

No results posted yet for this study

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

Conditions

  • HCV Related Cirrhosis

Interventions

DRUG

Sofosbuvir + Ribavirin 1

DRUG

Sofosbuvir + Ribavirin 2

DRUG

Sofosbuvir + Ribavirin 3

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Principal Investigators

  • Ankur Jindal, DM · Institute of Liver and Biliary Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02464631 on ClinicalTrials.gov