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Last Updated: May 17, 2022

CLINICAL TRIALS PROFILE FOR EPCLUSA


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505(b)(2) Clinical Trials for Epclusa

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT03513393 ↗ Influence of Cola on the Absorption of the HCV Agent Velpatasvir in Combination With PPI Omeprazole. Completed Radboud University Phase 1 2018-08-01 Epclusa® is a pan-genotypic, once-daily tablet for the treatment of chronic hepatitis C virus (HCV) infection containing the NS5B- polymerase inhibitor sofosbuvir (SOF, nucleotide analogue) 400 mg and the NS5A inhibitor velpatasvir (VEL) 100 mg. Velpatasvir has pH dependent absorption. At higher pH the solubility of velpatasvir decreases. It has been shown that in subjects treated with proton pump inhibitors (PPIs) such as omeprazole, the absorption of velpatasvir is reduced by 26-56%, depending on the dose of omeprazole, concomitant food intake, and timing/sequence of velpatasvir vs. omeprazole intake. As a result, concomitant intake of PPIs with velpatasvir is not recommended. For a number of reasons, the prohibition of PPI use with velpatasvir is a clinically relevant problem. First, PPI use is highly frequent in the HCV-infected subject population with prevalences reported up to 40%. Second, PPIs are available as over-the-counter medications and thus can be used by subjects without informing their physician. Third, although HCV therapy is generally well tolerated, gastro-intestinal symptoms such as abdominal pain and nausea are frequently reported, which my lead to PPI use. One solution of this problem could be the use of other acid-reducing agents such as H2-receptor antagonists or antacids. In general, they have a less pronounced effect on intragastric pH, and are considered less effective than PPIs by many patients and physicians. A second solution would be the choice of another HCV agent or combination that is not dependent on low gastric pH for its absorption such as daclatasvir. Daclatasvir, however, is not a pan-genotypic HCV agent and may be less effective against GT 2 and 3 infections than velpatasvir. Second, not all subjects have access to daclatasvir, depending on health insurance company or region where they live. A third solution, and the focus of this COPA study, is to add a glass of the acidic beverage cola at the time of velpatasvir administration in subjects concurrently treated with PPIs. This intervention has been shown to be effective for a number of drugs from other therapeutic classes who all have in common a reduced solubility (and thus reduced absorption) at higher intragastric pH, namely erlotinib, itraconazole, ketoconazole. The advantages of this approach are: (1) only a temporary decrease in gastric pH at the time of cola intake; the rest of the day the PPI will have its therapeutic effect (2) cola is available worldwide (3) the administration of cola can be done irrespective to the timing of PPI use.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Epclusa

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02300103 ↗ Efficacy And Safety Of Sofosbuvir/Velpatasvir Fixed Dose Combination With Ribavirin in Chronic HCV Infected Adults Who Participated in a Prior Gilead Sponsored HCV Treatment Study Completed Gilead Sciences Phase 2 2014-12-01 The primary objective of this study is to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) with ribavirin (RBV) for 24 weeks in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead sponsored study and did not achieve sustained virologic response (SVR).
NCT02639247 ↗ Safety and Efficacy of SOF/VEL/VOX FDC for 12 Weeks and SOF/VEL for 12 Weeks in DAA-Experienced Adults With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor Completed Gilead Sciences Phase 3 2015-12-23 The primary objectives of the study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks and of sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) FDC for 12 weeks in direct-acting antiviral (DAA)-experienced adults with chronic hepatitis C virus (HCV) infection with or without cirrhosis who have not received prior treatment with a regimen containing an inhibitor of the HCV NS5A protein.
NCT02743897 ↗ Transplanting Hepatitis C Kidneys Into Negative Kidney Recipients Active, not recruiting Merck Sharp & Dohme Corp. Phase 1/Phase 2 2016-05-01 This study is being conducted to determine safety and effectiveness of transplanting kidneys from Hepatitis C-positive donors into Hepatitis C-negative patients on the kidney transplant waitlist, who will then be treated with the appropriate direct-acting antiviral (DAA) after the single kidney transplantation.
NCT02743897 ↗ Transplanting Hepatitis C Kidneys Into Negative Kidney Recipients Active, not recruiting University of Pennsylvania Phase 1/Phase 2 2016-05-01 This study is being conducted to determine safety and effectiveness of transplanting kidneys from Hepatitis C-positive donors into Hepatitis C-negative patients on the kidney transplant waitlist, who will then be treated with the appropriate direct-acting antiviral (DAA) after the single kidney transplantation.
NCT02825212 ↗ Efficacy of All-Oral Anti-Viral Therapy for Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia Completed Gilead Sciences Phase 2/Phase 3 2016-02-01 10 patients with chronic genotype 1 HCV infection and mixed cryoglobulinemia will be treated with Ledipasvir/Sofosbuvir 90mg/400 mg FDC once daily for 12 weeks (naïve subjects or non-cirrhotic treatment experienced subjects) or 24 weeks (treatment experienced subjects with cirrhosis). The researchers anticipate that approximately 20% of subjects may have cirrhosis.
NCT02825212 ↗ Efficacy of All-Oral Anti-Viral Therapy for Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia Completed Icahn School of Medicine at Mount Sinai Phase 2/Phase 3 2016-02-01 10 patients with chronic genotype 1 HCV infection and mixed cryoglobulinemia will be treated with Ledipasvir/Sofosbuvir 90mg/400 mg FDC once daily for 12 weeks (naïve subjects or non-cirrhotic treatment experienced subjects) or 24 weeks (treatment experienced subjects with cirrhosis). The researchers anticipate that approximately 20% of subjects may have cirrhosis.
NCT02836925 ↗ Ledipasvir+Sofosbuvir and Sofosbuvir+Velpatasvir for Pts With Indolent Bcell Lymphoma Associated With HCV Infection Active, not recruiting Fondazione Italiana Linfomi ONLUS Phase 2 2016-03-01 This is a non-randomized, a single arm, phase II multicentre study of sofosbuvir plus ledipasvir (genotype 1 and 4) or sofosbuvir plus velpatasvir (genotype 2 and 3) for patients with hepatitis C virus-associated indolent B-cell lymphomas (HCV-RNA positive).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Epclusa

Condition Name

Condition Name for Epclusa
Intervention Trials
Hepatitis C 20
Hepatitis C, Chronic 10
End Stage Renal Disease 2
HCV 2
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Condition MeSH

Condition MeSH for Epclusa
Intervention Trials
Hepatitis C 36
Hepatitis 29
Hepatitis A 19
Hepatitis C, Chronic 12
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Clinical Trial Locations for Epclusa

Trials by Country

Trials by Country for Epclusa
Location Trials
United States 85
Australia 7
Italy 6
Canada 5
Puerto Rico 3
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Trials by US State

Trials by US State for Epclusa
Location Trials
Pennsylvania 13
Massachusetts 8
Maryland 7
New York 6
North Carolina 5
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Clinical Trial Progress for Epclusa

Clinical Trial Phase

Clinical Trial Phase for Epclusa
Clinical Trial Phase Trials
Phase 4 16
Phase 3 3
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Epclusa
Clinical Trial Phase Trials
Recruiting 10
Completed 10
Active, not recruiting 9
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Clinical Trial Sponsors for Epclusa

Sponsor Name

Sponsor Name for Epclusa
Sponsor Trials
Gilead Sciences 13
University of Pennsylvania 3
Massachusetts General Hospital 2
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Sponsor Type

Sponsor Type for Epclusa
Sponsor Trials
Other 51
Industry 16
NIH 4
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Serving leading biopharmaceutical companies globally:

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