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

NCT ID: NCT03061032

Last Updated: 2017-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-31

Study Completion Date

2019-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatitis C

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sofosbuvir/Ledipasvir for 12W

Patients without cirrhosis and previous history of treatment will be treated with this regimen.

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

Group Type EXPERIMENTAL

Sofosbuvir/Ledipasvir 12W

Intervention Type DRUG

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

Sofosbuvir/Ledipasvir+Ribavirin for 12W

Patients with compensated cirrhosis and/or previous history of treatment will be treated with this regimen.

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

Group Type EXPERIMENTAL

Sofosbuvir/Ledipasvir plus Ribavirin 12W

Intervention Type DRUG

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

Sofosbuvir/Ledipasvir for 24W

Patients with compensated or decompensated cirrhosis and/or previous history of treatment and with contraindication of Ribavirin will be treated with this regimen.

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

Group Type EXPERIMENTAL

Sofosbuvir/Ledipasvir 24W

Intervention Type DRUG

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

Sofosbuvir/Ledipasvir+Ribavirin for 24W

Patients with decompensated cirrhosis will be treated with this regimen. Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 24 weeks.

Group Type EXPERIMENTAL

Sofosbuvir/Ledipasvir plus Ribavirin 24W

Intervention Type DRUG

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

Interventions

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Sofosbuvir/Ledipasvir 12W

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

Intervention Type 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.

Intervention Type DRUG

Sofosbuvir/Ledipasvir 24W

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

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Chronic HCV infection
* \>18 years old

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baqiyatallah Research Center for Gastroenterology and Liver Diseases

OTHER

Sponsor Role collaborator

Iran Hepatitis Network

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Seyed Moayed Alavian, MD

Role: STUDY_CHAIR

Iran Hepatitis Network

Heidar Sharafi, PhD

Role: STUDY_DIRECTOR

Iran Hepatitis Network

Bita Behnava, MD

Role: PRINCIPAL_INVESTIGATOR

Iran Hepatitis Network

Mohammad Saeid Rezaee-Zavareh, MD

Role: PRINCIPAL_INVESTIGATOR

Iran Hepatitis Network

Central Contacts

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Seyed Moayed Alavian, MD

Role: CONTACT

[email protected]
+989121073195

Heidar Sharafi, PhD

Role: CONTACT

[email protected]
+989125176030

Other Identifiers

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IHN10002

Identifier Type: -

Identifier Source: org_study_id

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