NCT03200184

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,448

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 27, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

February 15, 2019

Status Verified

May 1, 2017

Enrollment Period

1.6 years

First QC Date

May 28, 2017

Last Update Submit

February 12, 2019

Conditions

Hepatitis C

Keywords

Hepatitis Csofosbuvirdaclatasvir

Outcome Measures

Primary Outcomes (1)

  • The sustained viral response rate

    Qualitative hepatitis C virus RNA polymerase chain reaction

    12 weeks after end of treatment

Secondary Outcomes (1)

  • Adverse drug events

    weeks 2, 4, 8, 12 and 24

Study Arms (1)

Treatment

EXPERIMENTAL

Subjects will receive sofosbuvir and daclatasvir

Drug: sofosbuvir and daclatasvir

Interventions

sofosbuvir and daclatasvirDRUG

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.

Also known as: Sovodak
Treatment

Eligibility Criteria

Age12 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Positive qualitative hepatitis C virus RNA test on two occasions at least 6 months apart

You may not qualify if:

  • Heart rate \< 50/min,
  • Taking amiodarone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shariati Hospital

Tehran, 14117, Iran

Location

Related Publications (1)

  • 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.

    PMID: 31504303DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

Sofosbuvirdaclatasvir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Uridine MonophosphateUracil NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Officials

  • Reza Malekzadeh, MD

    Tehran University of Medical Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2017

First Posted

June 27, 2017

Study Start

September 1, 2016

Primary Completion

April 1, 2018

Study Completion

September 1, 2018

Last Updated

February 15, 2019

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)