Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Fuji
Chubb
Mallinckrodt
Farmers Insurance
US Department of Justice
Citi
AstraZeneca
Fish and Richardson

Generated: December 17, 2018

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR EPCLUSA

« Back to Dashboard

Clinical Trials for Epclusa

Trial ID Title Status Sponsor Phase Summary
NCT03032666 Sofosbuvir/Ledipasvir for Hepatitis C Genotype 1-6 in Patients With Transfusion-Dependent Thalassemia: An Open Label Trial Not yet recruiting Gilead Sciences Phase 4 Sustained Viral Response following 12-week therapy (SVR 12) with sofosbuvir/ledipasvir in transfusion-dependent patients with HCV genotype 1-6 Secondary Objective(s): Assessment of transfusion requirements Adverse events Efficacy in treatment-naïve vs. relapsers vs. null responders Efficacy in patients with advanced fibrosis/cirrhosis vs. F1, F2 by elastography
NCT03032666 Sofosbuvir/Ledipasvir for Hepatitis C Genotype 1-6 in Patients With Transfusion-Dependent Thalassemia: An Open Label Trial Not yet recruiting Ala'a Sharara Phase 4 Sustained Viral Response following 12-week therapy (SVR 12) with sofosbuvir/ledipasvir in transfusion-dependent patients with HCV genotype 1-6 Secondary Objective(s): Assessment of transfusion requirements Adverse events Efficacy in treatment-naïve vs. relapsers vs. null responders Efficacy in patients with advanced fibrosis/cirrhosis vs. F1, F2 by elastography
NCT03036852 Sofosbuvir/Velpatasvir in Adults With Chronic Hepatitis C Virus Infection Who Are on Dialysis for End Stage Renal Disease Recruiting Gilead Sciences Phase 2 The primary objectives of this study are to evaluate safety, efficacy and tolerability of treatment with sofosbuvir (Sovaldi®)/velpatasvir (Epclusa®; SOF/VEL) for 12 weeks in adults with chronic hepatitis C virus (HCV) infection who are on dialysis for End Stage Renal Disease (ESRD).
NCT03057847 Sofosbuvir/Velpatasvir in Postpartum Women With Opioid Use Disorder and Chronic Hepatitis C Infection Not yet recruiting University of Pittsburgh Phase 4 Incorporating HCV treatment into opioid maintenance treatment program clinical protocols is an innovative health care delivery model that has been associated with improved HCV treatment uptake in non-pregnant, drug-using populations. This "medical home" approach would combine HCV and opioid maintenance treatment into one treatment regimen and incorporate the expertise of obstetricians, hepatologists, substance abuse treatment providers and pediatricians into one comprehensive clinical care model. The purpose of this study is to evaluate the feasibility/acceptability of a combined, peripartum HCV and opioid maintenance treatment program on adherence to HCV treatment regimens and evaluate the rate of IVDU recidivism, HCV reinfection and health related QOL in women with OUD during the first postpartum year. The protocol involves three separate study phases. All 3 study phases will occur with support from hepatology providers at Magee-Womens Hospital. Phase 1 involves screening, enrollment and a baseline assessment of liver function, HCV infection (genotype, viral load) and blood and urine studies in HCV-infected patients during pregnancy. In Phase 2, subjects will undergo 12 weeks of sofosbuvir/velpatasvir therapy initiated at 2 weeks postpartum. Feasibility/acceptability and adherence to sofosbuvir/velpatasvir will be assessed at 4, 8 and 12 weeks of therapy. In Phase 3, subjects will continue to be followed for 15 months after treatment completion. Treatment effectiveness and SVR will be evaluated at 3 months and rates of IVDU recidivism, HCV reinfection and patient centered outcomes such as health related quality of life (QOL) will be assessed at 6, 9 and 12 months following treatment completion.
NCT03207399 Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment: A Pilot Feasibility and Efficacy Study Not yet recruiting Duke University Phase 4 The purpose of this study is to evaluate whether treatment with Epclusa (sofosbuvir/velpatasvir) after lung transplantation in individuals with chronic hepatitis C infection is feasible, safe and effective at curing HCV.
NCT03222531 Expanding the Pool in Orthotopic Heart Transplantation Not yet recruiting University of Pittsburgh N/A To perform a study (100 patients) utilizing Hepatitis C positive donor hearts for hepatitis C negative donors with post-operative surveillance and treatment only if a recipient infection occurs.
Trial ID Title Status Sponsor Phase Summary

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial

Clinical Trial Conditions for Epclusa

Condition Name

Condition Name for Epclusa
Intervention Trials
Hepatitis C 9
Hepatitis C, Chronic 4
HIV-1-infection 2
Chronic Hepatitis C 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Condition MeSH

Condition MeSH for Epclusa
Intervention Trials
Hepatitis C 14
Hepatitis 10
Hepatitis C, Chronic 6
Hepatitis A 5
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Locations for Epclusa

Trials by Country

Trials by Country for Epclusa
Location Trials
United States 7
Canada 4
Netherlands 1
United Kingdom 1
New Zealand 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Trials by US State

Trials by US State for Epclusa
Location Trials
Maryland 2
Massachusetts 2
Pennsylvania 2
New York 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Progress for Epclusa

Clinical Trial Phase

Clinical Trial Phase for Epclusa
Clinical Trial Phase Trials
Phase 4 9
Phase 2 2
Phase 1 1
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Status

Clinical Trial Status for Epclusa
Clinical Trial Phase Trials
Not yet recruiting 10
Recruiting 3
Active, not recruiting 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Sponsors for Epclusa

Sponsor Name

Sponsor Name for Epclusa
Sponsor Trials
Gilead Sciences 5
University of Pittsburgh 2
Massachusetts General Hospital 2
[disabled in preview] 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Sponsor Type

Sponsor Type for Epclusa
Sponsor Trials
Other 12
Industry 6
NIH 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
QuintilesIMS
Colorcon
Citi
Cantor Fitzgerald
US Department of Justice
Chubb
Boehringer Ingelheim
Deloitte

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.