Treating Hepatitis C in CRF Using Sofosbuvir and Daclatasvir (SD-CRF)

September 27, 2019 updated by: Tehran University of Medical Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sovodak
Sofosbuvir 400 mg and daclatasvir 60 mg
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
Other Names:
  • Sovodak

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained Viral Response (SVR12)
Time Frame: 12 weeks after end of treatment
Lack of detectable hepatitis C virus in blood 12 weeks after end of treatment
12 weeks after end of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety as assessed by adverse drug events
Time Frame: From start of treatment to 12 weeks after end of treatment
Adverse drug events recorded by direct questioning
From start of treatment to 12 weeks after end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Collaborators

Shiraz University of Medical Sciences
Ahvaz Jundishapur University of Medical Sciences
Hamadan University of Medical Science

Investigators

  • Principal Investigator: Shahin Merat, MD, Tehran University Of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2017

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

February 21, 2017

First Submitted That Met QC Criteria

February 23, 2017

First Posted (Actual)

February 24, 2017

Study Record Updates

Last Update Posted (Actual)

September 30, 2019

Last Update Submitted That Met QC Criteria

September 27, 2019

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 96-04-37-37348

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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