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

NCT ID: NCT03200184

Last Updated: 2019-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1448 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2018-09-01

Brief Summary

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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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Detailed Description

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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

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Hepatitis C

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Subjects will receive sofosbuvir and daclatasvir

Group Type EXPERIMENTAL

sofosbuvir and daclatasvir

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Sovodak

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Reza Malekzadeh, MD

Role: STUDY_CHAIR

Tehran University of Medical Sciences

Locations

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Shariati Hospital

Tehran, , Iran

Site Status

Countries

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Iran

References

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Merat S; SD1000 Research Team. SD1000: High Sustained Viral Response Rate in 1361 Patients With Hepatitis C Genotypes 1, 2, 3, and 4 Using a Low-cost, Fixed-dose Combination Tablet of Generic Sofosbuvir and Daclatasvir: A Multicenter, Phase III Clinical Trial. Clin Infect Dis. 2020 May 6;70(10):2206-2212. doi: 10.1093/cid/ciz628.

Reference Type DERIVED
PMID: 31504303 (View on PubMed)

Other Identifiers

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IR.TUMS.DDRI.REC.1396.30

Identifier Type: -

Identifier Source: org_study_id

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