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
Design
Rostam 3 is a single cohort 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.
Settings and conduct
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 100 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 consumed to be acute HCV infection and the treatment would be postponed to 3 months after the positive test to let them have the chance of spontaneous clearance of HCV.
Participants/Inclusion and exclusion criteria
PWID with confirmed chronic HCV infection
Intervention groups
12 weeks of treatment with Sofosbuvir 400mg/Daclatasvir 60mg fixed dose combination
Main outcome variables
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
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170213032547N1
Registration date:2018-06-25, 1397/04/04
Registration timing:registered_while_recruiting
Last update:2018-06-25, 1397/04/04
Update count:3
Registration date
2018-06-25, 1397/04/04
Registrant information
Name
Heidar Sharafi
Name of organization / entity
Iran Hepatitis Network
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 5186
Email address
h.sharafi@meldcenter.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-10, 1397/03/20
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Sofosbuvir/Daclatasvir for Treatment of People Who Inject Drug with HCV Infection in a Community-based Setting
Public title
Hepatitis C Treatment in a Community-based Setting
Purpose
Treatment
Inclusion/Exclusion criteria
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
HIV/HCV Coinfection
HBV/HCV Coinfection
Acute hepatitis C
Pregnant woman
TB/HCV Coinfection
eGFR<30 mL/min or chronic renal failure
Drug-drug interactions
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Ibn sina St., Jahad Boulevard, Somayeh Cross road.
City
Kerman
Province
Kerman
Postal code
76169-13555
Approval date
2018-04-16, 1397/01/27
Ethics committee reference number
IR.KMU.REC.1396.2422
Health conditions studied
1
Description of health condition studied
Hepatitis C
ICD-10 code
B18.2
ICD-10 code description
Chronic viral hepatitis C
Primary outcomes
1
Description
Sustained Virologic Response
Timepoint
12 weeks after termination of treatment
Method of measurement
HCV RNA using sensitive RT-PCR
Secondary outcomes
1
Description
Treatment uptake
Timepoint
At the study entry
Method of measurement
Acceptance to be treated
2
Description
Treatment Adherence
Timepoint
12 weeks of treatment
Method of measurement
Pill count
Intervention groups
1
Description
Treatment with daily single-dose of Datex (400 mg Sofosbuvir/60 mg Daclatasvir) made in Sobhan Medicine Trade Development Company for 12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Monadian Salamat drop-in centre
Full name of responsible person
Dr. Armita Shahesmaeili
Street address
Next to Boustan Talar-Sarasiab Sq.
City
Kerman
Province
Kerman
Postal code
76169-13555
Phone
+98 34 3211 3012
Email
armita.shahesmaeili@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Sepehri
Street address
Ibn sina St., Jahad Boulevard, Somayeh Cross road.
City
Kerman
Province
Kerman
Postal code
76169-13555
Phone
+98 34 3211 3012
Email
vcr@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
10
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Armita Shahesmaeili
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
HIV Hub, Kerman University of Medical Sciences, Haft Bagh Alavi Road, Kerman
City
Kerman
Province
Kerman
Postal code
76169-13555
Phone
+98 34 3211 3012
Email
armita.shahesmaeili@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran Hepatitis Network
Full name of responsible person
Dr. Heidar Sharafi
Position
Scientific Director
Latest degree
Ph.D.
Other areas of specialty/work
Hepatology
Street address
No. 178, Cross shadab, Gharani St., Ferdowsi Sq.
City
Tehran
Province
Tehran
Postal code
1598976513
Phone
+98 21 8890 7154
Email
heidarsharafi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran Hepatitis Network
Full name of responsible person
Dr. Heidar Sharafi
Position
Scientific Director
Latest degree
Ph.D.
Other areas of specialty/work
Hepatology
Street address
No. 178, Cross shadab, Gharani St., Ferdowsi Sq.
City
Tehran
Province
Tehran
Postal code
1598976513
Phone
+98 21 8890 7154
Email
heidarsharafi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All available deidentified individual participant data will be shared.
When the data will become available and for how long
After publication of study.
To whom data/document is available
Researchers in the field.
Under which criteria data/document could be used
No additional publication can be conducted based on the shared data.
From where data/document is obtainable
Corresponding author of publication.
What processes are involved for a request to access data/document