The effect of generic drugs in treatment of chronic hepatitis C patients

Evaluation of Direct-Acting Antiviral Regimens Effectiveness in Achieving Undetectable Viral Load in Chronic Hepatitis C Patients in Iran

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017020210417N6

Enrollment

Registered

2017-03-05

Start date

2017-01-25

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Chronic viral hepatitis C. Chronic viral hepatitis C

Interventions

Intervention 1: Sofosbuvir, tablet, 400mg, oral, once a day plus ribavirin, cap, 1000-1200 mg (per body weight), oral, daily plus IFN alpha 2b amp, 1.5 µg/Kg, daily, all for 3 months * This regimen

Treatment - Drugs

Sofosbuvir, tablet, 400mg, oral, once a day plus ribavirin, cap, 1000-1200 mg (per body weight), oral, daily plus IFN alpha 2b amp, 1.5 µg/Kg, daily, all for 3 months * This regimen is used for ge

Ledipasvir/sofosbuvir, tablet, 90/400 mg, oral, once a day, all for 3 months * In patients with cirrhosis ribavirin cap, 100-1200 mg daily is added to the above regimen ** This regimen is use

Daclatasvir, tablet, 60 mg, oral, once a day plus sofosbuvir, tablet, 400 mg, oral, once a day, all for 3 months * In patients with cirrhosis ribavirin cap, 100-1200 mg daily is added to the

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Being diagnosed with hepatitis C and having a detectable viral count; Having not received any medications yet or being unresponsive to previous interferon-based treatments; Providing a freely signed consent form to be treated with new generic medications. Exclusion criteria :Having a renal failure defined as eGFR 20 or Child-Pugh score > 12; Heart rate < 50 beats/min; History of previous treatment failure with sofosbuvir-based regimen; History of taking amiodarone within the last 6 months; Not consenting to participate in the study.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Hepatitis C viral load. Timepoint: Beginig of treatment- one month after the begining of treatment- The end of treatment-Three months after the end of treatment. Method of measurement: Using Real Time PCR.;Hepatitis C virus genotype. Timepoint: at the beginning of treatment. Method of measurement: using gene sequencing.	—

Secondary

Measure	Time frame
Alanin amino transferase (ALT). Timepoint: At the beginning of treatment, then monthly for three months after the end of treatment. Method of measurement: Enzyme serum level.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Norooznezhad

Kermanshah University of Medical Sciences

fateme.noroznezhad@gmail.com+98 83 3437 6342

Outcome results

None listed

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