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

Phase 4

Completed

• Conditions: Hepatitis C
• Interventions: Drug: sofosbuvir and daclatasvir

• Registration Number: NCT03200184
• Lead Sponsor: Tehran University of Medical Sciences

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.

Study Timeline

• Study Start: 2016-09-01
• Status Verified: 2017-05
• Study First Submitted: 2017-05-28
• Study First Submitted QC: 2017-06-25
• Study First Posted: 2017-06-27
• Primary Completion: 2018-04-01
• Study Completion: 2018-09-01
• Last Update Submitted: 2019-02-12
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1448

Inclusion Criteria

• Positive qualitative hepatitis C virus RNA test on two occasions at least 6 months apart

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Exclusion Criteria

• Heart rate < 50/min,
• Taking amiodarone

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	sofosbuvir and daclatasvir	Subjects will receive sofosbuvir and daclatasvir

Primary Outcome Measures

Name	Time	Method
The sustained viral response rate	12 weeks after end of treatment	Qualitative hepatitis C virus RNA polymerase chain reaction

Secondary Outcome Measures

Name	Time	Method
Adverse drug events	weeks 2, 4, 8, 12 and 24	Questionnaire

Trial Locations

Locations (1)

Shariati Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of