Treating Hepatitis C in CRF Using Sofosbuvir and Daclatasvir

Hepatitis C, Chronic Clinical Trial

— SD-CRF  

Official title:

Efficacy and Safety of Sofosbuvir and Daclatasvir in Treating Patients With Hepatitis C and Renal Failure.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03063879
• Other study ID #: 96-04-37-37348
• Status: Completed
• Phase: Phase 4
• Start date: April 1, 2017
• Est. completion date: February 1, 2019

Study information

• Verified date: February 2018
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Sofosbuvir is the base of most treatment regimens for hepatitis C. In patients with renal failure the blood level of one of its metabolites (GS-331007) rises up to 20 folds. Although no particular adverse event has been linked to this metabolite sofosbuvir is not recommended for patients with renal failure mainly because of lack of data. Nevertheless there are anecdotal reports and small studies proving the safety of sofosbuvir in renal failure. This study addresses this lack of information by evaluating the safety and efficacy of sofosbuvir and daclatasvir in treating hepatitis C in 100 patients with renal failure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: February 1, 2019
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

Inclusion Criteria:

• Positive qualitative hepatitis C virus RNA test on two occasions at least 6 months apart

• Renal failure (eGFR < 30 cc/min) or under hemodialysis

Exclusion Criteria:

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

• Child's C (CTP score > 12),

• Heart rate < 50/min,

• Taking amiodarone

Related Conditions & MeSH terms

• Chronic Renal Failure
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• Sofosbuvir 400 mg and daclatasvir 60 mg
Daily fixed dose combination pill (Sovodak) containing 400 mg sofosbuvir and 60 mg daclatasvir for 12 weeks if not cirrhotic (liver stiffness < 12 KPa) or 24 weeks if cirrhotic

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences	Ahvaz Jundishapur University of Medical Sciences, Hamadan University of Medical Science, Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained Viral Response (SVR12)	Lack of detectable hepatitis C virus in blood 12 weeks after end of treatment	12 weeks after end of treatment
Secondary	Safety as assessed by adverse drug events	Adverse drug events recorded by direct questioning	From start of treatment to 12 weeks after end of treatment