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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR LEDIPASVIR; SOFOSBUVIR

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Clinical Trials for Ledipasvir; Sofosbuvir

Trial ID Title Status Sponsor Phase Summary
NCT01701401 Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV Completed Gilead Sciences Phase 3 The purpose of this study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir (LDV)/sofosbuvir (SOF) fixed-dose combination (FDC) tablets with or without ribavirin (RBV) administered for 12 and 24 weeks in treatment-naive subjects with chronic genotype 1 HCV infection.
NCT01726517 Safety and Efficacy of LDV/SOF Fixed-Dose Combination (FDC) ± Ribavirin in HCV Genotype 1 Subjects Completed Gilead Sciences Phase 2 This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV), administered for 8 or 12 weeks of treatment in participants with chronic genotype 1 hepatitis C virus (HCV) infection who are treatment-naive, and for 12 weeks in participants who had previously received a regimen containing a protease inhibitor for the treatment of HCV.
NCT01768286 Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Treatment-Experienced Subjects With Genotype 1 HCV Infection Completed Gilead Sciences Phase 3 This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir fixed dose combination (FDC) with or without ribavirin (RBV) administered for 12 or 24 weeks in treatment-experienced subjects with chronic genotype 1 hepatitis C virus (HCV) infection.
NCT01851330 Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin for the Treatment of HCV (ION-3) Completed Gilead Sciences Phase 3 This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV) administered for 8 or 12 weeks in treatment-naive participants with chronic genotype 1 HCV infection.
NCT01924949 Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Nosocomial Genotype 1 HCV Infection Completed Gilead Sciences Phase 2 This study is to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with nosocomial genotype 1 hepatitis C virus (HCV) infection.
NCT01938430 Ledipasvir/Sofosbuvir Fixed-Dose Combination + Ribavirin in Subjects With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant Completed Gilead Sciences Phase 2 This study will evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) in participants with advanced liver disease or posttransplant and chronic genotype 1 or 4 hepatitis C virus (HCV) infection. - Cohort A: decompensated cirrhosis (advanced liver disease), no prior liver transplant; - Cohort B: post-liver transplant, with or without cirrhosis; - Group assignment within cohorts is based on severity of liver impairment at screening (Child-Pugh-Turcotte (CPT) score for participants with cirrhosis; fibrosis; or presence of disease for fibrosing cholestatic hepatitis (FCH) groups) - Randomization is 1:1 within groups to 12 or 24 weeks of LDV/SOF+RBV treatment.
NCT01958281 Sofosbuvir Plus Ribavirin, or Ledipasvir/Sofosbuvir in Adults With HCV Infection and Renal Insufficiency Recruiting Gilead Sciences Phase 2 This study will evaluate the safety, tolerability and antiviral efficacy of sofosbuvir (SOF) with ribavirin (RBV) in participants with GT 1 and 3 and ledipasvir (LDV)/SOF in participants with genotype 1 and 4 HCV infection who have chronic renal insufficiency (impaired kidney function). Approximately 35 subjects with severe renal insufficiency (not on dialysis) will be enrolled in 3 cohorts. - Cohort 1 (GT 1 or 3): 10 subjects will receive SOF 200 mg + RBV 200 mg once daily for 24 weeks. - Cohort 2 (GT 1 or 3): Following review of safety, efficacy and pharmacokinetics (PK) data through post-treatment Week 4 of Cohort 1, 10 additional subjects will receive SOF 400 mg + RBV 200 mg once daily for 24 weeks. - Cohort 3 (GT 1 or 4): Following review of safety and available PK data through Week 12 of Cohort 2, 15 additional subjects will receive LDV/SOF 90/400 mg once daily for 12 weeks.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Ledipasvir; Sofosbuvir

Condition Name

Condition Name for Ledipasvir; Sofosbuvir
Intervention Trials
Hepatitis C 20
Hepatitis C Virus Infection 12
Hepatitis C, Chronic 6
Chronic HCV Infection 6
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Condition MeSH

Condition MeSH for Ledipasvir; Sofosbuvir
Intervention Trials
Hepatitis C 66
Hepatitis 53
Hepatitis A 30
Hepatitis C, Chronic 23
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Clinical Trial Locations for Ledipasvir; Sofosbuvir

Trials by Country

Trials by Country for Ledipasvir; Sofosbuvir
Location Trials
United States 264
Canada 21
Japan 14
Italy 9
France 8
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Trials by US State

Trials by US State for Ledipasvir; Sofosbuvir
Location Trials
California 19
Texas 18
New York 18
Maryland 14
Pennsylvania 14
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Clinical Trial Progress for Ledipasvir; Sofosbuvir

Clinical Trial Phase

Clinical Trial Phase for Ledipasvir; Sofosbuvir
Clinical Trial Phase Trials
Phase 4 19
Phase 3 20
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Ledipasvir; Sofosbuvir
Clinical Trial Phase Trials
Recruiting 29
Completed 28
Not yet recruiting 13
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Clinical Trial Sponsors for Ledipasvir; Sofosbuvir

Sponsor Name

Sponsor Name for Ledipasvir; Sofosbuvir
Sponsor Trials
Gilead Sciences 46
University of Maryland 3
National Institute of Allergy and Infectious Diseases (NIAID) 3
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Sponsor Type

Sponsor Type for Ledipasvir; Sofosbuvir
Sponsor Trials
Other 91
Industry 49
NIH 6
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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
US Army
Dow
Farmers Insurance
Daiichi Sankyo
AstraZeneca
QuintilesIMS
Mallinckrodt
Julphar

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