Sofosbuvir and Daclatasvir in Treating Hepatitis C, A Study on 1000 Patients (SD1000)

Tehran University of Medical Sciences

Status and phase: Completed; Phase 4

Conditions: Hepatitis C

Treatments: Drug: sofosbuvir and daclatasvir

Study type: Interventional

Funder types: Other

Identifiers

NCT03200184

IR.TUMS.DDRI.REC.1396.30

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,448 patients

Sex: All

Ages: 12 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,448 participants in 1 patient group

Treatment

Experimental group

Description:

Subjects will receive sofosbuvir and daclatasvir

Treatment:

Drug: sofosbuvir and daclatasvir