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

Hepatitis C Clinical Trial

— SL50  

Official title:

Sustained Viral Response Rate in 50 Subjects With Cirrhosis Due to Hepatitis C, Genotype 1, Treated With 12 Weeks of Sofosbuvir, Ledipasvir and Ribavirin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02705534
• Other study ID #: 94-04-37-31023
• Status: Completed
• Phase: Phase 3
• Start date: September 2016
• Est. completion date: October 2017

Study information

• Verified date: February 2017
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Cirrhosis due to Hepatitis C virus (HCV) presents a rather difficult treatment problem as many cannot tolerate interferon, the previous standard of care. The new direct acting antivirals have provided these patients with a new hope. One such combination is sofosbuvir (SOF) 400 mg and ledipasvir (LDV) 90 mg given once daily with or without weight-based ribavirin (RBV) for 12 or 24 weeks only for HCV genotype 1 patients. The current recommendation for cirrhotics (genotype 1) is SOF/LDV/RBV for 24 weeks but that recommendation is based on the lack of data for shorter periods. In order to evaluate the response rate to the combination of SOF/LDV/RBV the investigators decided to treat 50 HCV genotype 1 cirrhotics with this combination for 12 weeks. Patients with MELD score > 20 are excluded. The investigators will calculate the sustained viral response rate at 12 weeks (SVR12).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Hepatitis
• Hepatitis A
• Hepatitis C
• Liver Cirrhosis

Intervention

Drug:
• Sofosbuvir
400 mg, included in a combination pill with 90 mg ledipasvir
• Ledipasvir
90 mg, included in a combination pill with 400 mg sofosbuvir
• Ribavirin
1000 mg/day if <75 kg, 1200 mg/day for >75 kg. Divided into two daily doses

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shariati Hospital	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences	Bakhtar Bioshimi Co

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The sustained viral response rate	Qualitative polymerase chain reaction assay for Hepatitis C RNA	week 24 (12 weeks after end of treatment)
Secondary	Adverse drug events	Questionnaire	week 2, 4, 8, 12, 24