Hepatocellular Carcinoma Clinical Trial
— RCAPOfficial title:
Compassionate Use Access to REP 2139-Mg for the Treatment of Chronic HBV Infection or Chronic HBV / HDV Co-infection
NCT number | NCT05683548 |
Other study ID # | RCAP |
Secondary ID | |
Status | Available |
Phase | |
First received | |
Last updated |
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
Status | Available |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. Confirmed HBV or HBV / HDV co-infection. 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: 1. Women with positive serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG). 2. Breast-feeding women. |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University of Vienna | Vienna | |
France | 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 | |
Israel | Soroka Medical Center | Be'er Sheva | |
Italy | Padua University Hospital | Padua | |
Turkey | Koç University Medical School | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Replicor Inc. |
Austria, France, Israel, Italy, Turkey,
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. Erratum In: Lancet Gastroenterol Hepatol. 2018 Jan;3(1):e1. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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