Safety and Efficacy Study of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Genotype 1 and 3 Chronic HCV Infection
NCT ID: NCT01896193
Last Updated: 2015-05-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
127 participants
INTERVENTIONAL
2013-06-30
2014-06-30
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 16 Weeks
SOF+RBV for 16 weeks
SOF
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
RBV
Ribavirin (RBV) tablets administered orally in a divided daily dose using weight-based dosing (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
SOF+RBV 24 Weeks
SOF+RBV for 24 weeks
SOF
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
RBV
Ribavirin (RBV) tablets administered orally in a divided daily dose using weight-based dosing (\< 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) tablets administered orally in a divided daily dose using weight-based dosing (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HCV treatment-naive
* Individuals will have cirrhosis status assessment; liver biopsy may be required.
* Screening laboratory values within predefined thresholds
* Use of two effective contraception methods if female of childbearing potential or sexually active male
Exclusion Criteria
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
* Contraindication to ribavirin therapy
* Excessive alcohol ingestion as defined by protocol
* History of solid organ transplantation
* Current or prior history of clinical hepatic decompensation
* History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment, or compliance with the protocol
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, MSc
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Central Clinical Hospital of the Russian Academy of Sciences
Moscow, , Russia
Central Scientific and Research Institute of Epidemiology of Rospotrebnadzor
Moscow, , Russia
Central Scientific Research Institution of Gastroenterology of Moscow Healthcare Department
Moscow, , Russia
City Clinical Hospital 24
Moscow, , Russia
Clinical Diagnostics and Research Center of Federal Bedgetary Institution
Moscow, , Russia
Infectious Clinical Hospital No. 1
Moscow, , Russia
Institute of Nutrition of Academy of Sciences
Moscow, , Russia
Institution of Healthcare of Sverdlovsk Region
Moscow, , Russia
Institution of High Professional Education First Moscow State Medical University
Moscow, , Russia
Institution of Tumen Region
Moscow, , Russia
Krasnoyarsk Regional Center for Prevention and Control of AIDS and Infectious Diseases
Moscow, , Russia
Scientific Research Institution of Emergency Care n.a. N.V. Sclifosovskiy of Moscow
Moscow, , Russia
Stavropol State Medical University of Ministry of Healthcare
Moscow, , Russia
Medical Military Academy n.a. S.M. Kirov
Saint Petersburg, , Russia
Saint-Petersburg Center for Prevention and Control of AIDS and Infectious Diseases
Saint Petersburg, , Russia
Medical Company Hepatolog
Samara, , Russia
Countries
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References
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Isakov V, Zhdanov K, Kersey K, Svarovskaia E, Massetto B, Zhu Y, Knox SJ, Bakulin I, Chulanov V. Efficacy of sofosbuvir plus ribavirin in treatment-naive patients with genotype-1 and -3 HCV infection: results from a Russian Phase IIIb study. Antivir Ther. 2016;21(8):671-678. doi: 10.3851/IMP3065. Epub 2016 Jul 4.
Other Identifiers
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GS-US-334-0119
Identifier Type: -
Identifier Source: org_study_id