Protocol summary
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Study aim
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Evaluation of treatment efficacy and safety using 12-week regimen of Sofosbuvir, Daclatasvir in people who inject drug with HCV infection in a community-based setting
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Design
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Rostam 3 is an open label study of HCV new treatment in a group of PWID with HCV infection in a drop-in-center. This study aims to assess the adherence of this group to treatment and finally evaluate the treatment success to present a model for implementation of HCV treatment in community-based settings. The cases will be recruited from two cross-sectional (Rostam 1) and cohort (Rostam 2) studies which evaluate the prevalence and incidence of HCV in PWIDs.
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Settings and conduct
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The study will be conducted in Monadian Salamat drop-in centre, Kerman, Iran.
For those PWID who are reluctant to come to the study site, our team will visit them in mobile van.
This single arm clinical trial study will be conducted in 110 PWIDs infected with HCV confirmed with positive HCV RNA. Eligible PWIDs (from Rostam 1) who consented to participate in the study will be treated 12 weeks with daily oral Sofosbuvir 400mg/Daclatasvir 60mg and be followed up. Moreover, cases found to be HCV infected in Rostam 2 will be called to receive treatment in Rostam 3.
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Participants/Inclusion and exclusion criteria
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PWID with confirmed chronic HCV infection
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Intervention groups
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12 weeks of treatment with Sofosbuvir 400mg/Daclatasvir 60mg fixed dose combination
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Main outcome variables
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The main outcomes evaluated in this study are:
1. Treatment uptake: acceptance to receive Sofosbuvir/Daclatasvir treatment
2. Treatment adherence: completing the treatment course and receiving >80% of treatment doses
3. Sustained virologic response (SVR): Having negative result for HCV RNA, 12 weeks after treatment completion
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170213032547N1
Registration date:
2018-06-25, 1397/04/04
Registration timing:
registered_while_recruiting
Last update:
2019-05-28, 1398/03/07
Update count:
3
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Registration date
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2018-06-25, 1397/04/04
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-06-10, 1397/03/20
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Expected recruitment end date
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2019-07-23, 1398/05/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effectiveness of Sofosbuvir/Daclatasvir for Treatment of People Who Inject Drug with HCV Infection in a Community-based Setting
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Public title
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Hepatitis C Treatment in a Community-based Setting
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Being male or female (including transgender)
Being 18 years or older at the time of baseline interview
Self-reported drug injection with verification for non-medical purposes in the past twelve months
Having chronic infection of HCV as confirmed by HCV-RNA
Having lived for at least six months in Kerman and have no plan to move out for another three months
Having written informed consent to participate in the study
Understanding the Farsi language
Exclusion criteria:
Cirrhosis
HBV/HCV Coinfection
Pregnant woman
TB/HCV Coinfection
eGFR<30 mL/min or chronic renal failure
Drug-drug interactions
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Age
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From 18 years old to 80 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
110
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-04-16, 1397/01/27
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Ethics committee reference number
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IR.KMU.REC.1396.2422
Health conditions studied
1
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Description of health condition studied
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Hepatitis C
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ICD-10 code
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B18.2
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ICD-10 code description
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Chronic viral hepatitis C
Primary outcomes
1
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Description
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Sustained Virologic Response
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Timepoint
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12 weeks after termination of treatment
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Method of measurement
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HCV RNA using sensitive RT-PCR
Secondary outcomes
1
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Description
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Treatment uptake
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Timepoint
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At the study entry
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Method of measurement
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Acceptance to be treated
2
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Description
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Treatment Adherence
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Timepoint
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12 weeks of treatment
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Method of measurement
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Pill count
Intervention groups
1
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Description
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Treatment with daily single-dose of Daclasfovir Shari® (400 mg Sofosbuvir/60 mg Daclatasvir) made in Shari/Bakhtar Bioshimi Co (BBpharmaco) for 12 weeks.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kerman University of Medical Sciences
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Proportion provided by this source
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10
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
2
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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National Institute for Medical Research Development
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Proportion provided by this source
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90
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Other
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All available deidentified individual participant data will be shared.
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When the data will become available and for how long
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After publication of study.
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To whom data/document is available
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Researchers in the field.
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Under which criteria data/document could be used
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No additional publication can be conducted based on the shared data.
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From where data/document is obtainable
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Corresponding author of publication.
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What processes are involved for a request to access data/document
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A written request through email.
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Comments
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