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

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
sofosbuvir and daclatasvir
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C, sofosbuvir, daclatasvir

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shariati Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Subjects will receive sofosbuvir and daclatasvir

Outcomes

Primary Outcome Measures

The sustained viral response rate
Qualitative hepatitis C virus RNA polymerase chain reaction

Secondary Outcome Measures

Adverse drug events
Questionnaire

Full Information

First Posted
May 28, 2017
Last Updated
February 12, 2019
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03200184
Brief Title
Sofosbuvir and Daclatasvir in Treating Hepatitis C, A Study on 1000 Patients
Acronym
SD1000
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
April 1, 2018 (Actual)
Study Completion Date
September 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
Hepatitis C, sofosbuvir, daclatasvir

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1448 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Subjects will receive sofosbuvir and daclatasvir
Intervention Type
Drug
Intervention Name(s)
sofosbuvir and daclatasvir
Other Intervention Name(s)
Sovodak
Intervention Description
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.
Primary Outcome Measure Information:
Title
The sustained viral response rate
Description
Qualitative hepatitis C virus RNA polymerase chain reaction
Time Frame
12 weeks after end of treatment
Secondary Outcome Measure Information:
Title
Adverse drug events
Description
Questionnaire
Time Frame
weeks 2, 4, 8, 12 and 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Malekzadeh, MD
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Shariati Hospital
City
Tehran
ZIP/Postal Code
14117
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31504303
Citation
Merat S; SD1000 Research Team. SD1000: High Sustained Viral Response Rate in 1361 Patients With Hepatitis C Genotypes 1, 2, 3, and 4 Using a Low-cost, Fixed-dose Combination Tablet of Generic Sofosbuvir and Daclatasvir: A Multicenter, Phase III Clinical Trial. Clin Infect Dis. 2020 May 6;70(10):2206-2212. doi: 10.1093/cid/ciz628. Erratum In: Clin Infect Dis. 2020 May 23;70(11):2459. Clin Infect Dis. 2021 Jul 1;73(1):172.
Results Reference
derived

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

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