MedTrace Logo

Treating Hepatitis C in CRF Using Sofosbuvir and Daclatasvir

NCT03063879 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2019-09-30

No results posted yet for this study

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.

Conditions

  • Hepatitis C, Chronic
  • Chronic Renal Failure

Interventions

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

Sponsors & Collaborators

  • Ahvaz Jundishapur University of Medical Sciences

    collaborator OTHER

  • Shiraz University of Medical Sciences

    collaborator OTHER

  • Hamadan University of Medical Science

    collaborator OTHER

  • Tehran University of Medical Sciences

    lead OTHER

Principal Investigators

  • Shahin Merat, MD · Tehran University of Medical Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2018-09-01
Completion
2019-02-01

Countries

  • Iran

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03063879 on ClinicalTrials.gov