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Completed

NCT Number: NCT03200184

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

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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

12 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shariati Hospital

Tehran, 14117, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sofosbuvir and daclatasvir

Drug

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.

Other names: Sovodak

Primary outcomes

  1. The sustained viral response rate

    Time frame: 12 weeks after end of treatment

    Qualitative hepatitis C virus RNA polymerase chain reaction

Secondary outcomes

  1. Adverse drug events

    Time frame: weeks 2, 4, 8, 12 and 24

    Questionnaire

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Acronym: SD1000

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 27, 2017
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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