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Hepatitis C Treatment in a Community-based Setting

Effectiveness of Sofosbuvir/Daclatasvir for Treatment of People Who Inject Drug with HCV Infection in a Community-based Setting

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20170213032547N1
Enrollment
110
Registered
2018-06-25
Start date
2018-06-10
Completion date
Unknown
Last updated
2019-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C. Chronic viral hepatitis C

Interventions

Treatment with daily single-dose of Daclasfovir Shari® (400 mg Sofosbuvir/60 mg Daclatasvir) made in Shari/Bakhtar Bioshimi Co (BBpharmaco) for 12 weeks..

Sponsors

Kerman University of Medical Sciences
Lead Sponsor
National Institute for Medical Research Development
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion 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

Exclusion criteria: Cirrhosis HBV/HCV Coinfection Pregnant woman TB/HCV Coinfection eGFR<30 mL/min or chronic renal failure Drug-drug interactions

Design outcomes

Primary

MeasureTime frame
Sustained Virologic Response. Timepoint: 12 weeks after termination of treatment. Method of measurement: HCV RNA using sensitive RT-PCR.

Secondary

MeasureTime frame
Treatment uptake. Timepoint: At the study entry. Method of measurement: Acceptance to be treated.;Treatment Adherence. Timepoint: 12 weeks of treatment. Method of measurement: Pill count.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Armita Shahesmaeili

Kerman University of Medical Sciences

armita.shahesmaeili@gmail.com+98 34 3211 3012

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026