Sofosbuvir, Daclatasvir, Ribavirin for Hepatitis C Virus (HCV) Cirrhotics

Hepatitis C Clinical Trial

— SD100  

Official title:

Sustained Viral Response Rate in 100 Subjects With Cirrhosis Due to Hepatitis C Treated With 12 Weeks of Sofosbuvir, Daclatasvir and Ribavirin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02596880
• Other study ID #: 94-02-159-30278
• Status: Completed
• Phase: Phase 3
• Start date: September 2015
• Est. completion date: June 2016

Study information

• Verified date: April 2023
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators will treat 100 patients with cirrhosis due to hepatitis C with sofosbuvir 400 mg daily, daclatasvir 60 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 presents a rather difficult treatment problem as many cannot tolerate interferon, the previous standard of treatment. The new direct acting antivirals have provided these patients with a new hope. One such combination is sofosbuvir (SOF) 400 mg and daclatasvir (DCV) 60 mg given once daily with or without weight-based ribavirin (RBV) for 12 or 24 weeks. The current recommendation for cirrhotics is SOF/DCV/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/DCV/RBV the investigators decided to treat 100 HCV cirrhotics with this combination for 12 weeks. Subjects include genotype 1 and 3 patients, the prevalent genotypes in Iran. Patients with Model for End stage Liver Disease (MELD) > 20 are excluded. The investigators will calculate the sustained viral response rate at 12 weeks (SVR12).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Positive qualitative HCV RNA test on two occasions at least 6 months apart

• Cirrhosis proven by either of: 1. Liver biopsy, 2. Liver elasticity > 12 kilopascal (KPa), 3. Clinical certainty (ascites, splenomegaly, small liver, low albumin, low platelet)

Exclusion Criteria:

• Renal failure (eGFR < 30 cc/min),

• MELD score > 20,

• Child's C (CTP 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 (Sovodak) with 60 mg daclatasvir
• Daclatasvir
60 mg, included in a combination pill (Sovodak) 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 (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

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 HCV RNA polymerase chain reaction (PCR)	week 24 (12 weeks after end of treatment)
Secondary	Adverse drug events	Questionnaire	week 2, 4, 8, 12, 24