Sofosbuvir and Daclatasvir in Treating Hepatitis C, A Study on 1000 Patients (SD1000)

February 12, 2019 updated by: Tehran University of Medical Sciences
The fixed-dose combination of sofosbuvir and daclatasvir in a single pill is being used for the treatment of hepatitis C in Iran. In this study the efficacy of this combination is evaluated in 1000 patient with hepatitis C.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All cases of hepatitis C whether cirrhotic, post organ transplant, co-infected with HIV or hepatitis B, active drug abuse, on immune suppression and from all genotypes will be included. Patients will be treated by a single daily dose of a fixed-dose combination pill of 400mg sofosbuvir and 60 mg daclatasvir for 12 weeks. If a patient is cirrhotic, defined by liver stiffness > 12 kilopascal, either weight based ribavirin will be added or the treatment duration will be prolonged to 24 weeks.

Study Type

Interventional

Enrollment (Actual)

1448

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

12 years to 75 years (ADULT, OLDER_ADULT, CHILD)

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

Exclusion Criteria:

  • 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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment
Subjects will receive sofosbuvir and daclatasvir
Drug: sofosbuvir and daclatasvir
A fixed dose combination pill containing 400mg sofosbuvir and 60 mg daclatasvir given daily for 12 weeks. If a patient is cirrhotic, treatment duration would be 24 weeks.
Other Names:
  • Sovodak

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The sustained viral response rate
Time Frame: 12 weeks after end of treatment
Qualitative hepatitis C virus RNA polymerase chain reaction
12 weeks after end of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse drug events
Time Frame: weeks 2, 4, 8, 12 and 24
Questionnaire
weeks 2, 4, 8, 12 and 24

Collaborators and Investigators

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

Sponsor

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)

September 1, 2016

Primary Completion (ACTUAL)

April 1, 2018

Study Completion (ACTUAL)

September 1, 2018

Study Registration Dates

First Submitted

May 28, 2017

First Submitted That Met QC Criteria

June 25, 2017

First Posted (ACTUAL)

June 27, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 12, 2019

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IR.TUMS.DDRI.REC.1396.30

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

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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