Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NO_LONGER_AVAILABLE
EXPANDED_ACCESS
Brief Summary
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This compassionate access program will provide access to a once weekly regimen of subcutaneously (SC) administered REP 2139-Mg for a period of 48 weeks with the goal of achieving functional cure of HDV and or HBV, with the reversal of liver disease in the absence of antiviral therapy. The safety, tolerability and efficacy of SC REP 2139-Mg will be monitored during and after therapy
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Detailed Description
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The Replicor compassionate access program (RCAP) provides early access to individuals which have HBV mono-infection, or HBV / HDV co-infection who have not responded to existing approved or experimental therapies and are in danger of progressing advanced liver disease or who have already progressed to decompensated cirrhosis. Examples of previous therapy includes but is not limited to pegylated interferon (pegIFN), bulevirtide or lonafarnib.
Participants with failure to previous therapy with compensated cirrhosis will receive REP 2139-Mg (250mg SC qW), TDF (300mg PO QD) and pegIFN (90ug SC qW) for 48 weeks. Participants with decompensated cirrhosis will receive REP 2139-Mg (250mg SC qW) and TDF (300mg PO QD).
During therapy, safety will be monitored weekly and efficacy every 4 weeks.
Patients who maintain HBsAg loss for 6 months following removal of REP 2139-Mg and pegIFN will be eligible for removal of the remaining TDF therapy.
Conditions
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Interventions
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REP 2139-Mg
REP 2139-Mg is the magnesium chelate complex of REP 2139
Tenofovir Disoproxil Fumarate
Pegylated interferon alpha2a
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Prior failure to pegIFN, bulevirtide, or lonafarnib or combinations thereof with advanced fibrosis or compensated cirrhosis.
3. Decompensated cirrhosis.
4. Willingness to utilize adequate contraception while being treated with REP 2139-Mg and for 6 months following the end of REP 2139-Mg treatment.
Exclusion Criteria
2. Breast-feeding women.
18 Years
70 Years
ALL
No
Sponsors
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Replicor Inc.
INDUSTRY
Responsible Party
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Locations
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Medical University of Vienna
Vienna, , Austria
AP-HP Hôpital Beaujon
Clichy, , France
CHU Lille
Lille, , France
CHU-Limoges
Limoges, , France
Hôpital Saint-Joseph
Marseille, , France
Centre Hospitalier Universitaire de Montpellier
Montpellier, , France
CHU de Montpellier
Montpellier, , France
Centre Hospitalier de Perpignan
Perpignan, , France
CHU de Rennes
Rennes, , France
CHU Rangueil, Université Toulouse 3
Toulouse, , France
Soroka Medical Center
Beersheba, , Israel
Padua University Hospital
Padua, , Italy
Koç University Medical School
Istanbul, , Turkey (Türkiye)
Countries
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References
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Vaillant A. REP 2139: Antiviral Mechanisms and Applications in Achieving Functional Control of HBV and HDV Infection. ACS Infect Dis. 2019 May 10;5(5):675-687. doi: 10.1021/acsinfecdis.8b00156. Epub 2018 Oct 5.
Blanchet M, Sinnathamby V, Vaillant A, Labonte P. Inhibition of HBsAg secretion by nucleic acid polymers in HepG2.2.15 cells. Antiviral Res. 2019 Apr;164:97-105. doi: 10.1016/j.antiviral.2019.02.009. Epub 2019 Feb 13.
Boulon R, Blanchet M, Lemasson M, Vaillant A, Labonte P. Characterization of the antiviral effects of REP 2139 on the HBV lifecycle in vitro. Antiviral Res. 2020 Nov;183:104853. doi: 10.1016/j.antiviral.2020.104853. Epub 2020 Jun 23.
Bazinet M, Pantea V, Cebotarescu V, Cojuhari L, Jimbei P, Albrecht J, Schmid P, Le Gal F, Gordien E, Krawczyk A, Mijocevic H, Karimzadeh H, Roggendorf M, Vaillant A. Safety and efficacy of REP 2139 and pegylated interferon alfa-2a for treatment-naive patients with chronic hepatitis B virus and hepatitis D virus co-infection (REP 301 and REP 301-LTF): a non-randomised, open-label, phase 2 trial. Lancet Gastroenterol Hepatol. 2017 Dec;2(12):877-889. doi: 10.1016/S2468-1253(17)30288-1. Epub 2017 Sep 28.
Bazinet M, Pantea V, Cebotarescu V, Cojuhari L, Jimbei P, Anderson M, Gersch J, Holzmayer V, Elsner C, Krawczyk A, Kuhns MC, Cloherty G, Dittmer U, Vaillant A. Persistent Control of Hepatitis B Virus and Hepatitis Delta Virus Infection Following REP 2139-Ca and Pegylated Interferon Therapy in Chronic Hepatitis B Virus/Hepatitis Delta Virus Coinfection. Hepatol Commun. 2020 Nov 13;5(2):189-202. doi: 10.1002/hep4.1633. eCollection 2021 Feb.
Bazinet M, Pantea V, Placinta G, Moscalu I, Cebotarescu V, Cojuhari L, Jimbei P, Iarovoi L, Smesnoi V, Musteata T, Jucov A, Dittmer U, Krawczyk A, Vaillant A. Safety and Efficacy of 48 Weeks REP 2139 or REP 2165, Tenofovir Disoproxil, and Pegylated Interferon Alfa-2a in Patients With Chronic HBV Infection Naive to Nucleos(t)ide Therapy. Gastroenterology. 2020 Jun;158(8):2180-2194. doi: 10.1053/j.gastro.2020.02.058. Epub 2020 Mar 6.
Related Links
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Repicor Inc.
Interaction of NAPs with HDAg
Other Identifiers
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RCAP
Identifier Type: -
Identifier Source: org_study_id
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