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Sofosbuvir Plus Ribavirin in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection

NCT ID: NCT01713283

Last Updated: 2014-11-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-02-28

Brief Summary

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This study is to evaluate the safety, tolerability, and antiviral activity of sofosbuvir (SOF) with ribavirin (RBV) in Egyptian adults with chronic genotype 4 hepatitis C virus (HCV) infection.

Detailed Description

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Conditions

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Hepatitis C Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SOF+RBV 12 Weeks

Treatment-naive and treatment-experienced participants will receive SOF+RBV for 12 weeks.

Group Type EXPERIMENTAL

SOF

Intervention Type DRUG

Sofosbuvir (SOF) 400 mg tablet administered orally once daily

RBV

Intervention Type DRUG

Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

SOF+RBV 24 Weeks

Treatment-naive and treatment-experienced participants will receive SOF+RBV for 24 weeks.

Group Type EXPERIMENTAL

SOF

Intervention Type DRUG

Sofosbuvir (SOF) 400 mg tablet administered orally once daily

RBV

Intervention Type DRUG

Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

Interventions

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SOF

Sofosbuvir (SOF) 400 mg tablet administered orally once daily

Intervention Type DRUG

RBV

Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

Intervention Type DRUG

Other Intervention Names

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GS-7977 PSI-7977 Sovaldi®

Eligibility Criteria

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Inclusion Criteria

* First generation Egyptian; must have been born in Egypt and can trace both maternal and paternal Egyptian ancestry
* Treatment-experienced or treatment-naive
* Chronic genotype 4 HCV infection
* Not co-infected with HIV
* Screening laboratory values within defined thresholds
* Use of highly effective contraception methods
* Must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments

Exclusion Criteria

* History of any other clinically significant chronic liver disease
* Pregnant or nursing female or male with pregnant female partner
* History of clinically-significant illness or any other major medical disorder that may interfere with treatment, assessment, or compliance with the protocol
* Excessive alcohol ingestion or significant drug abuse
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathryn Kersey, MSc

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

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Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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GS-US-334-0114

Identifier Type: -

Identifier Source: org_study_id