NCT03200184

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,448 (actual)
• Sponsor: Tehran University of Medical Sciences · Academic / Other
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-09-01
• Primary completion: 2018-04-01
• Completion: 2018-09-01
• First posted: 2017-06-27
• Last updated: 2019-02-15

Locations

1 site across 1 country: Iran