Trials / Unknown
UnknownNCT03061032
Treatment of Hepatitis C Virus Infection With Generic Sofosbuvir/Ledipasvir in Iranian Patients
Open-label Study of Efficacy and Safety of Generic Sofosbuvir/Ledipasvir±Ribavirin in Iranian Patients With Hepatitis C Virus Genotype 1 Infection
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Iran Hepatitis Network · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2017-03-01
- Primary completion
- 2018-12-01
- Completion
- 2019-07-01
- First posted
- 2017-02-23
- Last updated
- 2017-02-23
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03061032. Inclusion in this directory is not an endorsement.