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Generated: December 16, 2018

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CLINICAL TRIALS PROFILE FOR SOFOSBUVIR

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Clinical Trials for Sofosbuvir

Trial ID Title Status Sponsor Phase Summary
NCT01054729 Dose-Ranging Study of Sofosbuvir in Combination With Pegylated Interferon and Ribavirin in Treatment Naïve GT 1 HCV Patients Completed Gilead Sciences Phase 2 Participants with genotype 1 HCV infection were randomized to 1 of 3 sofosbuvir doses (100 mg, 200 mg, or 400 mg) or matching placebo once daily based upon stratification for IL28B status (CC or CT/TT). Placebo tablets were administered to participants receiving 100 mg active sofosbuvir (3 placebo tablets) and 200 mg active sofosbuvir (2 placebo tablets) in order to maintain the study blind. Participants received sofosbuvir/matching placebo from Day 0 to 27. Participants also received treatment with PEG+RBV starting on Day 0 of the study which continued for 48 weeks. Participants were evaluated for sustained virologic response (SVR) for an additional 24 weeks following completion of study treatment.
NCT01188772 Sofosbuvir in Combination With Pegylated Interferon and Ribavirin and in Treatment-Naive Hepatitis C-infected Patients Completed Gilead Sciences Phase 2 Genotype 1: Participants with genotype 1 hepatitis C (HCV) infection were randomized to receive sofosbuvir (GS-7977; PSI-7977) 200 mg or 400 mg, or matching placebo, plus pegylated interferon alfa 2a (PEG) and ribavirin (RBV) for 12 weeks, followed by PEG+RBV for an up to an additional 36 weeks. Randomization was stratified by IL28B status (CC, CT, TT) and HCV RNA level (< 800,000 IU/ml or ≥ 800,000 IU/ml) at baseline. Participants were randomized in a 2:2:1 manner; those who achieved an extended rapid virologic response (eRVR) (HCV RNA < lower limit of detection [15 IU/mL] from Weeks 4 through 12) received an additional 12 weeks of PEG+RBV. Subjects not achieving eRVR received an additional 36 weeks of PEG+RBV. Genotype 2 and 3: Participants with genotype 2 or 3 hepatitis C (HCV) received sofosbuvir 400 mg plus PEG+RBV for 12 weeks.
NCT01260350 Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3 Completed Gilead Sciences Phase 2 This study is to assess the safety and tolerability of sofosbuvir (SOF) 400 mg with and without ribavirin (RBV) and/or with and without pegylated interferon alfa-2a (PEG) in subjects with genotype 1, 2 or 3 hepatitis C (HCV) infection.
NCT01329978 Sofosbuvir With Pegylated Interferon and Ribavirin Hepatitis C Virus (HCV) Genotypes 1,4,5,6 Completed Gilead Sciences Phase 2 The purpose of this study is to assess the safety, tolerability, and efficacy of sofosbuvir (GS-7977; PSI-7977) administered in combination with pegylated interferon and ribavirin (PEG/RBV) in treatment-naive patients with HCV genotypes 1,4,5,6, or indeterminate genotype.
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).
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Sofosbuvir

Condition Name

Condition Name for Sofosbuvir
Intervention Trials
Hepatitis C 77
Hepatitis C Virus Infection 43
Chronic Hepatitis C 23
Hepatitis C, Chronic 22
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Condition MeSH

Condition MeSH for Sofosbuvir
Intervention Trials
Hepatitis C 216
Hepatitis 165
Hepatitis A 103
Hepatitis C, Chronic 87
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Clinical Trial Locations for Sofosbuvir

Trials by Country

Trials by Country for Sofosbuvir
Location Trials
Canada 103
Australia 76
United Kingdom 55
China 51
New Zealand 48
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Trials by US State

Trials by US State for Sofosbuvir
Location Trials
California 71
Texas 65
New York 58
Florida 55
Maryland 53
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Clinical Trial Progress for Sofosbuvir

Clinical Trial Phase

Clinical Trial Phase for Sofosbuvir
Clinical Trial Phase Trials
Phase 4 47
Phase 3 74
Phase 2/Phase 3 6
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Clinical Trial Status

Clinical Trial Status for Sofosbuvir
Clinical Trial Phase Trials
Completed 103
Recruiting 69
Not yet recruiting 32
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Clinical Trial Sponsors for Sofosbuvir

Sponsor Name

Sponsor Name for Sofosbuvir
Sponsor Trials
Gilead Sciences 115
Bristol-Myers Squibb 11
AbbVie 11
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Sponsor Type

Sponsor Type for Sofosbuvir
Sponsor Trials
Other 200
Industry 173
NIH 9
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