Replicor Compassionate Access Program
RCAP
Compassionate Use Access to REP 2139-Mg for the Treatment of Chronic HBV Infection or Chronic HBV / HDV Co-infection
1 other identifier
expanded_access
N/A
5 countries
13
Brief Summary
The goal of this compassionate access program is to provide early access to REP 2139-Mg for patients with HBV mono-infection or HBV / HDV co-infection who either have advanced (decompensated) cirrhosis or who have failed to response to other other antiviral agents either approved or under development and who are in danger of progressing to decompensated cirrhosis. 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
Trial Health
Trial Health Score
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13 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 4, 2023
CompletedFirst Posted
Study publicly available on registry
January 13, 2023
CompletedFebruary 17, 2025
February 1, 2025
January 4, 2023
February 13, 2025
Conditions
Keywords
Interventions
REP 2139-Mg is the magnesium chelate complex of REP 2139
Eligibility Criteria
You may qualify if:
- Confirmed HBV or HBV / HDV co-infection.
- Prior failure to pegIFN, bulevirtide, or lonafarnib or combinations thereof with advanced fibrosis or compensated cirrhosis.
- Decompensated cirrhosis.
- Willingness to utilize adequate contraception while being treated with REP 2139-Mg and for 6 months following the end of REP 2139-Mg treatment.
You may not qualify if:
- Women with positive serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG).
- Breast-feeding women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Replicor Inc.lead
Study Sites (13)
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)
Related Publications (7)
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.
PMID: 30199230BACKGROUNDBlanchet 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.
PMID: 30771404BACKGROUNDBoulon 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.
PMID: 32585322BACKGROUNDBazinet 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.
PMID: 28964701BACKGROUNDBazinet 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.
PMID: 33553968BACKGROUNDBazinet 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.
PMID: 32147484BACKGROUNDStern C, Loustaud-Ratti V, Yurdaydin C, Brancaccio G, Jachs M, Reiberger T, Bardou-Jacquet E, Metivier S, Alric L, Colombain L, Meszaros M, Mathurin P, Yardeni D, Etzion O, Neumann-Haefelin C, Douglas M, Poulin S, Bazinet M, Metin RO, Vitale A, Gaeta GB, Schwarz M, Ben-Ali S, Bedoya JU, Testoni B, Zoulim F, Plissonnier ML, Levrero M, Paradis V, Francois S, de Freitas C, Kaysin F, Lecomte L, Morvan C, Schramko J, Bondezi K, Baril ME, Brichler S, Gerber A, Gordien E, Mackiewicz V, Dahari H, Svicher V, Chevaliez S, Vaillant A, Bourliere M. Safety and efficacy of REP 2139-Mg in patients with HDV-related advanced liver disease in an international compassionate access program. J Hepatol. 2025 Nov 6:S0168-8278(25)02612-1. doi: 10.1016/j.jhep.2025.10.029. Online ahead of print.
PMID: 41205755DERIVED