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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR SOVALDI

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Clinical Trials for Sovaldi

Trial ID Title Status Sponsor Phase Summary
NCT01435044 Safety Study of Regimens of Sofosbuvir, GS-0938, and Ribavirin in Patients With Chronic Hepatitis C Infection Completed Quintiles, Inc. Phase 2 This study was designed to assess the safety and efficacy of multiple interferon-free treatment regimens of sofosbuvir (Sovaldi™; GS-7977; PSI-7977) and GS-0938 (PSI-352938) alone and in combination, with and without ribavirin (RBV). Each regimen was to be evaluated over 12 and 24 weeks to identify the optimal duration of therapy to maximize the benefit (sustained virologic response [SVR]) versus risk (safety and resistance).
NCT01435044 Safety Study of Regimens of Sofosbuvir, GS-0938, and Ribavirin in Patients With Chronic Hepatitis C Infection Completed Gilead Sciences Phase 2 This study was designed to assess the safety and efficacy of multiple interferon-free treatment regimens of sofosbuvir (Sovaldi™; GS-7977; PSI-7977) and GS-0938 (PSI-352938) alone and in combination, with and without ribavirin (RBV). Each regimen was to be evaluated over 12 and 24 weeks to identify the optimal duration of therapy to maximize the benefit (sustained virologic response [SVR]) versus risk (safety and resistance).
NCT01962441 SOF (Sovaldi®) +RBV for 16 or 24 Weeks and SOF+RBV+Peg-IFN for 12 Weeks in Adults With Genotype 2 or 3 Chronic HCV Infection Completed Gilead Sciences Phase 3 This study will assess the efficacy, safety, and tolerability of 16 or 24 weeks of sofosbuvir (Sovaldi®; SOF) + ribavirin (RBV), and 12 weeks of SOF+RBV+peginterferon alfa-2a (Peg-IFN) in treatment-naive and treatment-experienced adults with chronic genotype 3 hepatitis C virus (HCV) infection, and treatment-experienced adults with cirrhosis and chronic genotype 2 HCV infection.
NCT02156570 DAA-based Therapy for Recently Acquired Hepatitis C II (DAA = Directly Acting Antiviral) Active, not recruiting Kirby Institute Phase 4 The purpose of the study is to examine whether patients who have acute or early chronic hepatitis C virus (HCV) infection can be treated effectively and safely with an interferon-sparing regimen that combines a new direct acting antiviral drug (sofosbuvir) with one of the standard treatments for chronic hepatitis C (ribavirin). In particular, this study will investigate whether treatment of acute or early chronic HCV can be shortened. The study will assess efficacy by looking at the proportion of people who clear the virus (have no virus detectable in their blood) at the end of treatment, and 1, 3 and 6 months after treatment. The hypothesis is that short course (6 weeks) dual therapy using sofosbuvir and RBV will result in successful virological eradication in the majority (≥80%) of subjects treated for recently acquired HCV.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Sovaldi

Condition Name

Condition Name for Sovaldi
Intervention Trials
Hepatitis C 6
Chronic Hepatitis C 3
Healthy 3
Hepatitis C Virus Infection 2
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Condition MeSH

Condition MeSH for Sovaldi
Intervention Trials
Hepatitis C 18
Hepatitis 17
Hepatitis A 14
Hepatitis, Chronic 9
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Clinical Trial Locations for Sovaldi

Trials by Country

Trials by Country for Sovaldi
Location Trials
United States 63
Australia 10
Canada 10
United Kingdom 10
New Zealand 8
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Trials by US State

Trials by US State for Sovaldi
Location Trials
California 6
Texas 5
Colorado 5
Washington 4
Tennessee 4
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Clinical Trial Progress for Sovaldi

Clinical Trial Phase

Clinical Trial Phase for Sovaldi
Clinical Trial Phase Trials
Phase 4 6
Phase 3 4
Phase 2 6
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Clinical Trial Status

Clinical Trial Status for Sovaldi
Clinical Trial Phase Trials
Active, not recruiting 7
Completed 6
Recruiting 5
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Clinical Trial Sponsors for Sovaldi

Sponsor Name

Sponsor Name for Sovaldi
Sponsor Trials
Gilead Sciences 7
AbbVie 4
Janssen Scientific Affairs, LLC 3
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Sponsor Type

Sponsor Type for Sovaldi
Sponsor Trials
Other 25
Industry 23
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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Fuji
UBS
McKesson
Healthtrust
Teva
AstraZeneca
Mallinckrodt
Deloitte

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