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NCT03200184 Clinical Trial

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
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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