drugset / Trial / NCT02464631

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

NCT02464631

RandomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2015-06
Primary completion
2016-12
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ribavirin Small molecule 600 mg Oral
Comparator Ribavirin Small molecule 800 mg Oral
Comparator Ribavirin Small molecule 1000 mg Oral
Comparator Sofosbuvir Small molecule 400 mg Oral