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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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03200184
Study type Interventional
Source Tehran University of Medical Sciences
Contact
Status Completed
Phase Phase 4
Start date September 1, 2016
Completion date September 1, 2018

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