MedTrace Logo

Treatment of Hepatitis C Virus Infection With Generic Sofosbuvir/Ledipasvir in Iranian Patients

NCT03061032 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2017-02-23

No results posted yet for this study

Summary

Hepatitis C virus (HCV) infection with around 0.5% and 2.2% prevalence in Iran and world is one of the public health problems resulting in chronic liver disease, cirrhosis and hepatocellular carcinoma. All cases of chronic HCV infections are candidates of treatment to prevent advanced liver diseases. The previous Pegylated-interferon and Ribavirin therapy was not efficient in all cases and results in numerous number of side-effects. Introduction of direct acting antiviral agents (DAAs) such as Sofosbuvir and Ledipasvir make the eradication of HCV possible however these regimens are not affordable and available in developing countries. The generic DAAs are manufactured in many of these countries such as Iran to provide the treatment with reasonable price.

Conditions

  • Hepatitis C

Interventions

DRUG

Sofosbuvir/Ledipasvir 12W

Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 12 weeks.

DRUG

Sofosbuvir/Ledipasvir plus Ribavirin 12W

Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 12 weeks.

DRUG

Sofosbuvir/Ledipasvir 24W

Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 24 weeks.

DRUG

Sofosbuvir/Ledipasvir plus Ribavirin 24W

Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 24 weeks.

Sponsors & Collaborators

  • Baqiyatallah Research Center for Gastroenterology and Liver Diseases

    collaborator OTHER

  • Iran Hepatitis Network

    lead OTHER

Principal Investigators

  • Seyed Moayed Alavian, MD · Iran Hepatitis Network

  • Heidar Sharafi, PhD · Iran Hepatitis Network

  • Bita Behnava, MD · Iran Hepatitis Network

  • Mohammad Saeid Rezaee-Zavareh, MD · Iran Hepatitis Network

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-31
Primary Completion
2018-12-31
Completion
2019-07-31
FDA Drug
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03061032 on ClinicalTrials.gov