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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03200184
Recruitment Status : Completed
First Posted : June 27, 2017
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: sofosbuvir and daclatasvir Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1448 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : September 1, 2016
Actual Primary Completion Date : April 1, 2018
Actual Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment
Subjects will receive sofosbuvir and daclatasvir
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.
Other Name: Sovodak




Primary Outcome Measures :
  1. The sustained viral response rate [ Time Frame: 12 weeks after end of treatment ]
    Qualitative hepatitis C virus RNA polymerase chain reaction


Secondary Outcome Measures :
  1. Adverse drug events [ Time Frame: weeks 2, 4, 8, 12 and 24 ]
    Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200184


Locations
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Iran, Islamic Republic of
Shariati Hospital
Tehran, Iran, Islamic Republic of, 14117
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
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Study Chair: Reza Malekzadeh, MD Tehran University of Medical Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03200184    
Other Study ID Numbers: IR.TUMS.DDRI.REC.1396.30
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tehran University of Medical Sciences:
Hepatitis C
sofosbuvir
daclatasvir
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Sofosbuvir
Antiviral Agents
Anti-Infective Agents