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

Hepatitis C Clinical Trial

— SD1000  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03200184
• Other study ID #: IR.TUMS.DDRI.REC.1396.30
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2016
• Est. completion date: September 1, 2018

Study information

• Verified date: May 2017
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1448
• Est. completion date: September 1, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The sustained viral response rate	Qualitative hepatitis C virus RNA polymerase chain reaction	12 weeks after end of treatment
Secondary	Adverse drug events	Questionnaire	weeks 2, 4, 8, 12 and 24