Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1

• Status: Completed
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators will treat 50 patients with cirrhosis due to hepatitis C genotype 1, with sofosbuvir 400 mg daily, ledipasvir 90 mg daily and weight-based ribavirin (1000 mg/d if <75 kg, 1200 mg/d if >75 kg, divided in two daily doses) for 12 weeks and calculate the sustained viral response rate at 12 weeks.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tehran University of Medical Sciences
• Collaborator: Bakhtar Bioshimi Co
• Treatments: Ledipasvir; Ribavirin; Sofosbuvir

Criteria

Inclusion Criteria:

• Positive qualitative hepatitis C RNA polymerase chain reaction assay on two occasions at least 6 months apart

Exclusion Criteria:

• Renal failure [estimated glomerular filtration rate (eGFR) < 30 cc/min],

• Model or End stage Liver Disease (MELD) score > 20,

• Child's class C (score > 12),

• Heart rate < 50/min,

• Taking amiodarone