Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection
NCT ID: NCT01838590
Last Updated: 2015-05-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
103 participants
INTERVENTIONAL
2013-03-31
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SOF+RBV 12 Weeks
Participants will receive SOF+RBV for 12 weeks.
SOF
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
RBV
Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
SOF+RBV 24 Weeks
Participants will receive SOF+RBV for 24 weeks.
SOF
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
RBV
Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Interventions
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SOF
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
RBV
Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Chronic genotype 4 HCV-infection
* Not co-infected with HIV
* Screening laboratory values within defined thresholds
* Use of highly effective contraception methods
* Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.
Exclusion Criteria
* 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 subject treatment, assessment or compliance with the protocol
* Excessive alcohol ingestion or significant drug abuse
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Kathryn Kersey
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Al Mansurah, , Egypt
Cairo, , Egypt
Countries
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Other Identifiers
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GS-US-334-0138
Identifier Type: -
Identifier Source: org_study_id
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