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

Hepatitis C Clinical Trial

— HepCC-2  

Official title:

Open-label Study of Efficacy and Safety of Generic Sofosbuvir/Ledipasvir±Ribavirin in Iranian Patients With Hepatitis C Virus Genotype 1 Infection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03061032
• Other study ID #: IHN10002
• Status: Not yet recruiting
• Phase: Phase 3
• First received: February 13, 2017
• Last updated: February 17, 2017
• Start date: March 2017
• Est. completion date: July 2019

Study information

• Verified date: February 2017
• Source: Iran Hepatitis Network
• Contact: Seyed Moayed Alavian, MD
• Phone: +989121073195
• Email: alavian[@]thc.ir
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: July 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chronic HCV infection

• >18 years old

Exclusion Criteria:

• HIV co-infected

• Liver transplanted

• Receiving drugs with suspected interactions

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• Sofosbuvir/Ledipasvir 12W
Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 12 weeks.
• Sofosbuvir/Ledipasvir plus Ribavirin 12W
Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 12 weeks.
• Sofosbuvir/Ledipasvir 24W
Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 24 weeks.
• Sofosbuvir/Ledipasvir plus Ribavirin 24W
Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 24 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Iran Hepatitis Network	Baqiyatallah Research Center for Gastroenterology and Liver Diseases

Outcome

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