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Last Updated: July 16, 2020

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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. Not yet recruiting 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
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 2017-02-15 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 2017-02-15 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 2017-03-22 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 2017-09-01 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.
NCT03086044 Transplanting Hepatitis C Positive Thoracic Organs Recruiting Brigham and Women's Hospital Phase 4 2017-03-01 This is an open-label, pilot safety and efficacy trial for adults who are active on the heart or lung transplantation lists and are eligible to receive an organ from an increased risk donor who has evidence of active or prior hepatitis C infection (HCV).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Epclusa

Condition Name

Condition Name for Epclusa
Intervention Trials
Hepatitis C 13
Hepatitis C, Chronic 7
Chronic Hepatitis C 3
HIV-1-infection 2
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Condition MeSH

Condition MeSH for Epclusa
Intervention Trials
Hepatitis C 23
Hepatitis 19
Hepatitis A 13
Hepatitis C, Chronic 10
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Clinical Trial Locations for Epclusa

Trials by Country

Trials by Country for Epclusa
Location Trials
United States 19
Canada 5
New Zealand 1
Taiwan 1
Netherlands 1
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Trials by US State

Trials by US State for Epclusa
Location Trials
Pennsylvania 6
Massachusetts 4
Maryland 3
New York 2
Tennessee 1
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Clinical Trial Progress for Epclusa

Clinical Trial Phase

Clinical Trial Phase for Epclusa
Clinical Trial Phase Trials
Phase 4 11
Phase 3 1
Phase 2 5
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Clinical Trial Status

Clinical Trial Status for Epclusa
Clinical Trial Phase Trials
Not yet recruiting 16
Recruiting 6
Active, not recruiting 1
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Clinical Trial Sponsors for Epclusa

Sponsor Name

Sponsor Name for Epclusa
Sponsor Trials
Gilead Sciences 8
University of Pittsburgh 2
Massachusetts General Hospital 2
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Sponsor Type

Sponsor Type for Epclusa
Sponsor Trials
Other 25
Industry 9
NIH 3
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