NCT02464631

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

To Evaluate the Safety and Efficacy of Sofosbuvir and Ribavirin in Patients With HCV (Genotype 3) Related Decompensated Cirrhosis" - A Randomized Open- Label Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Sofosbuvir + Ribavirin 1
DRUG	Sofosbuvir + Ribavirin 2
DRUG	Sofosbuvir + Ribavirin 3

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2015-06-08
• Last updated: 2017-01-19

Locations

1 site across 1 country: India