Liver Diseases  >>  ledipasvir/sofosbuvir  >>  Phase 2
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13 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
ledipasvir/sofosbuvir / Generic mfg.
NCT02120300: Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects With Chronic Hepatitis C Virus (HCV) and Inherited Bleeding Disorders

Completed
2b
122
US
LDV/SOF, Harvoni®, GS-5885/GS-7977, SOF, Sovaldi®, GS-7977, PSI-7977, RBV
Gilead Sciences
Chronic HCV Infection
08/15
08/15
NCT01726517: Safety and Efficacy of LDV/SOF Fixed-Dose Combination (FDC) ± Ribavirin in HCV Genotype 1 Subjects

Checkmark APASL 2014: LONESTAR
Mar 2014 - Mar 2014: APASL 2014: LONESTAR
Checkmark HepDART 2013: LONESTAR & ELECTRON
Dec 2013 - Dec 2013: HepDART 2013: LONESTAR & ELECTRON
Checkmark LONESTAR
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Completed
2
100
US
LDV/SOF, Harvoni®, RBV
Gilead Sciences
Chronic Hepatitis C Virus
07/13
01/14
NCT01260350: Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3

Checkmark EASL 2014: ELECTRON
Mar 2014 - Mar 2014: EASL 2014: ELECTRON
Checkmark APASL 2014: ELECTRON
Mar 2014 - Mar 2014: APASL 2014: ELECTRON
Checkmark HepDART 2013: LONESTAR & ELECTRON
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Completed
2
292
RoW
SOF, Sovaldi®, GS-7977, PSI-7977, RBV, Copegus®, PEG, Pegasys®, LDV, GS-5885, GS-9669, LDV/SOF, Harvoni®
Gilead Sciences
Chronic Hepatitis C Infection
10/13
12/13
NCT01938430: Ledipasvir/Sofosbuvir Fixed-Dose Combination + Ribavirin in Subjects With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant

Checkmark DDW 2016 (SOLAR1 and SOLAR 2)
Apr 2016 - Apr 2016: DDW 2016 (SOLAR1 and SOLAR 2)
Checkmark ILC 2016 (SOLAR1 and SOLAR 2)
Mar 2016 - Mar 2016: ILC 2016 (SOLAR1 and SOLAR 2)
Checkmark ILC 2015
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Completed
2
339
US
LDV/SOF, Harvoni®, GS-5885/GS-7977, RBV
Gilead Sciences
Chronic HCV Infection
01/15
03/15
NCT01826981: Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection in Participants With Chronic Genotype 1, 2, 3, or 6 HCV Infection

Completed
2
359
RoW
LDV/SOF, Harvoni®, GS-5885/GS-7977, SOF, GS-7977, Sovaldi®, RBV, Peg-IFN, Pegasys®, GS-9669, VEL, GS-5816
Gilead Sciences
Chronic Hepatitis C
03/15
05/15
NCT02010255 / 2013-002802-30: Ledipasvir/Sofosbuvir Fixed-Dose Combination Plus Ribavirin in Participants With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant

Checkmark DDW 2016 (SOLAR1 and SOLAR 2)
Apr 2016 - Apr 2016: DDW 2016 (SOLAR1 and SOLAR 2)
Checkmark ILC 2016 (SOLAR1 and SOLAR 2)
Mar 2016 - Mar 2016: ILC 2016 (SOLAR1 and SOLAR 2)
Checkmark DDW 2015
More
Completed
2
334
Canada, Europe, RoW
LDV/SOF, Harvoni®, GS-5885/GS-7977, RBV
Gilead Sciences
Chronic HCV Infection
05/15
08/15
NCT02219685: Ledipasvir/Sofosbuvir Fixed-Dose Combination on Cerebral Metabolism and Neurocognition in Treatment-Naive and Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection

Completed
2
40
US
LDV/SOF, Harvoni®, GS-5885/GS-7977, Placebo
Gilead Sciences
Hepatitis C Virus Infection
08/15
04/16
NCT02125500 / 2013-002607-33: Pilot Study to Assess Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-dose Combination in Treatment Experienced Subjects With Hepatitis C Virus (HCV) Genotype 1 - HIV Co-infection

Checkmark ILC 2016 (ANRS HC31 SOFTRIH study)
Mar 2016 - Mar 2016: ILC 2016 (ANRS HC31 SOFTRIH study)
Completed
2
68
Europe
Sofosbuvir/Ledipasvir fixed dose, Sofosbuvir is also known as GS-7977 or PSI-7977., Ledipasvir is also known as GS-5885.
ANRS, Emerging Infectious Diseases
Viral Hepatitis C, HIV
12/15
12/15
LEPTON, NCT02202980: Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection

Completed
2
273
RoW
LDV/SOF, Harvoni®, GS-5885/GS-7977, RBV, SOF/VEL, Epclusa®, GS-7977/GS-5816, VOX, GS-9857
Gilead Sciences
Chronic Hepatitis C
03/16
05/16
NCT02251717 / 2014-002121-35: Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic HCV Infection

Completed
2
114
Europe
LDV/SOF, Harvoni®, GS-5885/GS-7977
Gilead Sciences
Hepatitis C Virus Infection
03/16
06/16
NCT02350569: Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination Administered in Patients Infected With Chronic Genotype 1 or 4 HCV for Use in the Peri-Operative Liver Transplantation Setting

Completed
2
17
US
LDV/SOF, Harvoni®, GS-5885/GS-7977
Gilead Sciences
Hepatitis C Virus Infection
03/16
04/16
NCT02301936: Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 or 24 Weeks in Genotype 1 or 4 HCV Infected Adults With Sickle Cell Disease

Checkmark P2 data of SLASH C trial
Sep 2015 - Sep 2015: P2 data of SLASH C trial
Completed
2
10
US
LDV/SOF, Harvoni®, GS-5885/GS-7977
Gilead Sciences
Hepatitis C Virus Infection
04/16
04/16
NCT02309918 / 2013-001081-42: HepNet Acute HCV IV - LDV/SOF FDC in Acute Genotype 1 Hepatitis C Virus Infection

Completed
2
20
Europe
LDV/SOF FDC
HepNet Study House, German Liverfoundation, Hannover Medical School, Gilead Sciences
Acute Hepatitis C
08/16
08/16

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