Upcoming/Recruiting HCV Clinical Trials - Sofosbuvir Based Including Ledipasvir/Sofosbuvir

Clinical trials on this page are not a complete list; to learn more about HCV trials or to find out if a study is enrolling patients in your area, please click here. View additional hepatitis trials updated in the last 30 days @ ClinicalTrials.gov

For additional information visit HCV Advocate News and Pipeline for trial updates;

AbbVie
Bristol-Myers Squibb (BMS)
Gilead
Merck
Tibotec / Janssen
**Quick Reference Guide*

Simeprevir/Sofosbuvir/Ribavirin

Not yet recruiting
Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Subjects With Chronic Genotype 4 Hepatitis C Virus Infection
Conditions: Chronic Hepatitis C; Genotype 4 Chronic Hepatitis C
Interventions: Drug: Simeprevir; Drug: Sofosbuvir Sofosbuvir/Ribavirin
ClinicalTrials.gov Identifier: NCT02250807
Sponsor: Janssen Infectious Diseases BVBA

Simeprevir/Sofosbuvir

Not yet recruiting

Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Subjects With Chronic Genotype 4 Hepatitis C Virus Infection

Conditions: Genotype 4 Chronic Hepatitis C
Drug: Simeprevir
Drug: Sofosbuvir
Phase 3

ClinicalTrials.gov Identifier: NCT02256176

Sponsor: Janssen R&D Ireland

Recruiting

Sofosbuvir/Ribavirin - Adolescents and Children

Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection

Conditions: Hepatitis C Virus Infection
Drug: SOF
Drug: RBV
Phase 2

ClinicalTrials.gov Identifier: NCT02175758

Sofosbuvir/Ribavirin 

Not yet recruiting
DAA-based Therapy for Recently Acquired Hepatitis C II (DAA = Directly Acting Antiviral)
Condition: Hepatitis C
Intervention: Drug: Sofosbuvir and ribavirin
ClinicalTrials.gov Identifier: NCT02156570

Recruiting
Efficacy and Safety of Sofosbuvir+Ribavirin in Genotype 2 HCV-infected U.S. Veterans With Cirrhosis
Condition: Hepatitis C Virus Infection
Interventions: Drug: Sofosbuvir; Drug: RBV
ClinicalTrials.gov Identifier: NCT02128542

Recruiting
Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Chronic Genotype 1 or 3 HCV Infection
Condition: Chronic HCV Infection
Interventions: Drug: Sofosbuvir; Drug: RBV
ClinicalTrials.gov Identifier: NCT02074514

Sofosbuvir/GS-5816

Recruiting

Comparison of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Adults With Chronic Genotype 3 HCV Infection (ASTRAL-3)

Condition: Hepatitis C Virus Infection
Drug: SOF/GS-5816
Drug: SOF
Drug: RBV
Phase 3

ClinicalTrials.gov Identifier: NCT02201953

Ledipasvir/Sofosbuvir and Vedroprevir With or Without Ribavirin
Recruiting
Ledipasvir/Sofosbuvir Fixed-Dose Combination and Vedroprevir With or Without Ribavirin in Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection and Cirrhosis
Condition:
Hepatitis C Virus Infection
Interventions:
Drug: LDV/SOF; Drug: VDV; Drug: RBV
ClinicalTrials.gov Identifier: NCT02226549

Ledipasvir/Sofosbuvir - Adolescents and Children

This study is not yet open for participant recruitment
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination in Adolescents and Children With Chronic HCV-Infection

Condition: Hepatitis C Virus Infection
Drug: LDV/SOF
Phase 2

ClinicalTrials.gov Identifier: NCT02249182

Ledipasvir/Sofosbuvir

Recruiting
Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection
Condition: Chronic Hepatitis C
Interventions: Drug: LDV/SOF; Drug: RBV
Phase: Phase 2
ClinicalTrials.gov Identifier:
NCT02202980
Other IDs: NCT02202980
GS-US-337-1468

This study is not yet open for participant recruitment
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
Condition:
Hepatitis C Virus Infection
Intervention:
Drug: LDV/SOF
ClinicalTrials.gov Identifier: NCT02251717

Recruiting
Ledipasvir/Sofosbuvir Fixed-Dose Combination on Cerebral Metabolism and Neurocognition in Treatment-Naive and Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection
Condition:
Hepatitis C Virus Infection
Interventions:
Drug: LDV/SOF; Drug: Placebo to match LDV/SOF
ClinicalTrials.gov Identifier: NCT02219685

This study is not yet open for participant recruitment
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination in Adolescents and Children With Chronic HCV-Infection
Condition:
Hepatitis C Virus Infection
Intervention:
Drug: LDV/SOF
ClinicalTrials.gov Identifier: NCT02249182

Enrolling by invitation
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Subjects With Chronic Genotype 1 HCV Who Participated in a Prior Gilead-Sponsored HCV Treatment Study
Condition:
HCV Infection
Interventions:
Drug: LDV/SOF; Drug: RBV
ClinicalTrials.gov Identifier: NCT01987453

Recruiting
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects With Chronic Hepatitis C Virus (HCV) and Inherited Bleeding Disorders
Condition:
Chronic HCV Infection
Interventions:
Drug: LDV/SOF; Drug: Sofosbuvir; Drug: Ribavirin
ClinicalTrials.gov Identifier: NCT02120300

HIV Co-infection
Sofosbuvir/Ledipasvir

Not yet recruiting
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
Conditions: Viral Hepatitis C; HIV
Intervention: Drug: Sofosbuvir/Ledipasvir fixed dose
ClinicalTrials.gov Identifier: NCT02125500

HIV Co-infection
Simeprevir and Sofosbuvir

Not yet recruiting
A Study of the Safety and Effectiveness of Simeprevir and Sofosbuvir for Patients With HIV and Hepatitis C
Conditions: Hepatitis C, Chronic; HIV CDC Category A1
Intervention: Drug: Sofosbuvir + Simeprevir
ClinicalTrials.gov Identifier: NCT02206932