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Last Updated: September 26, 2021

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CLINICAL TRIALS PROFILE FOR LEDIPASVIR; SOFOSBUVIR

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All Clinical Trials for Ledipasvir; Sofosbuvir

Trial ID Title Status Sponsor Phase Start Date 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 2012-09-01 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 2012-10-01 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 2013-01-01 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 2013-05-01 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 2013-07-01 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 2013-09-01 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ledipasvir; Sofosbuvir

Condition Name

Condition Name for Ledipasvir; Sofosbuvir
Intervention Trials
Hepatitis C 22
Hepatitis C Virus Infection 12
Hepatitis C, Chronic 8
Chronic Hepatitis C 8
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Condition MeSH

Condition MeSH for Ledipasvir; Sofosbuvir
Intervention Trials
Hepatitis C 75
Hepatitis 59
Hepatitis A 36
Hepatitis C, Chronic 28
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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
Egypt 16
Japan 14
Australia 9
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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 23
Phase 3 23
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Ledipasvir; Sofosbuvir
Clinical Trial Phase Trials
Recruiting 36
Completed 32
Not yet recruiting 16
[disabled in preview] 11
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Clinical Trial Sponsors for Ledipasvir; Sofosbuvir

Sponsor Name

Sponsor Name for Ledipasvir; Sofosbuvir
Sponsor Trials
Gilead Sciences 46
Cairo University 3
University of Maryland 3
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Sponsor Type

Sponsor Type for Ledipasvir; Sofosbuvir
Sponsor Trials
Other 109
Industry 51
NIH 6
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