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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03061032

Acronym

HepCC-2

Enrollment

200

Registered

2017-02-23

Start date

2017-03-31

Completion date

2019-07-31

Last updated

2017-02-23

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

Conditions

Hepatitis C

Brief 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.

Interventions

DRUGSofosbuvir/Ledipasvir 12W

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

DRUGSofosbuvir/Ledipasvir plus Ribavirin 12W

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

DRUGSofosbuvir/Ledipasvir 24W

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

DRUGSofosbuvir/Ledipasvir plus Ribavirin 24W

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Chronic HCV infection * \>18 years old

Exclusion criteria

* HIV co-infected * Liver transplanted * Receiving drugs with suspected interactions

Design outcomes

Primary

Measure	Time frame	Description
Sustained Virologic Response	12 weeks after completion of treatment	Undetectable HCV RNA 12 weeks after completion of treatment with RT-PCR or TMA with a 15 IU/mL limit of detection

Contacts

Primary ContactSeyed Moayed Alavian, MD

alavian@thc.ir+989121073195

Backup ContactHeidar Sharafi, PhD

h.sharafi@meldcenter.com+989125176030

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026