Effect of Combination Therapy with Ledipasvir and Sofosbuvir (Hepasbuvir Plus) for Treatment of Patients with Hepatitis C Infection

Effect of Combination Therapy with Ledipasvir and Sofosbuvir (Hepasbuvir Plus) with or without Ribavirin for Treatment of Iranian Patients with Genotype-1 Hepatitis C Virus Infection

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016050717413N15

Enrollment

Registered

2017-04-24

Start date

2015-03-21

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 hepatitis C infection. Chronic viral hepatitis C

Interventions

Treatment with daily single-dose of Hepasbuvir plus (400 mg sofosbuvir/90 mg ledipasvir) made in Danesh pharmaceutical developmental co. Ribavirn (200 mg) can be added to the treatment protocol (five

Treatment - Drugs

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Iranian patients with genotype-1 hepatitis C virus infection; with minimum age of 18 year old; with or without previous history of treatment (Peg-Interferon, Ribavirin, Protease inhibitors including: Telaprevir and Boceprevir); Compensated or Decompensated Cirrhosis; Exclusion Criteria: Co-infection with HIV infection; Patients with thalassemia; Patients with hemophilia; Patients with history of chronic hemodialysis; patients with history of liver transplantation

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Hepatitis C Viral load. Timepoint: Before starting therapy, 4 weeks after starting therapy, end of therapy, 4 weeks after end of therapy, 12 weeks after end of therapy. Method of measurement: Quantitative viral load in laboratory.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Saeid Rezaee-Zavareh

Baqiyatallah Research Center for Gastroenterology and Liver Diseases, Baqiyatallah University of Med

Dr_Rezaee@Live.com+98 21 8861 4523

Outcome results

None listed

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