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AzTrials

Viral Hepatitis BRCAPNCT05683548

Replicor Compassionate Access Program

A study testing REP 2139-Mg, Tenofovir Disoproxil Fumarate and Pegylated interferon alpha2a in people with Viral Hepatitis B and Viral Hepatitis D, run by Replicor Inc. at 13 sites in 5 countries.

No Longer Available

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
REP 2139-Mg, Tenofovir Disoproxil Fumarate and Pegylated interferon alpha2a
How many people
Not given
Where
13 sitesin 5 countries
Study dates
Start not givento not given
Phase
Expanded access
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Women with positive serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG).
  • Breast-feeding women.

Trial locations and contacts

13 sites in 5 countries.

13 sites in 5 countries

France9 sites

  • AP-HP Hôpital Beaujon

    Clichy

  • CHU Lille

    Lille

  • CHU-Limoges

    Limoges

  • Hôpital Saint-Joseph

    Marseille

  • Centre Hospitalier Universitaire de Montpellier

    Montpellier

  • CHU de Montpellier

    Montpellier

  • Centre Hospitalier de Perpignan

    Perpignan

  • CHU de Rennes

    Rennes

  • CHU Rangueil, Université Toulouse 3

    Toulouse

Other trials in France

Austria1 site

  • Medical University of Vienna

    Vienna

Other trials in Austria

Israel1 site

  • Soroka Medical Center

    Beersheba

Other trials in Israel

Italy1 site

  • Padua University Hospital

    Padua

Other trials in Italy

Turkey (Türkiye)1 site

  • Koç University Medical School

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Compassionate Use Access to REP 2139-Mg for the Treatment of Chronic HBV Infection or Chronic HBV / HDV Co-infection

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

Read the detailed description

Nucleic acid polymers (NAPs) block the assembly of hepatitis B virus (HBV) subviral particles and bind to the small and large hepatitis delta virus (HDV) antigen. In chronic HBV mono-infection, this leads to rapid HBsAg loss and in chronic HBV / HDV co-infection, simultaneous loss of HBsAg and HDV RNA. NAP-based combination therapy (using REP 2139-Mg) achieves high rates of functional cure of HBV and HDV in the absence of therapy in previous clinical trials limited to patients without cirrhosis.

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.

Being tested
REP 2139-Mg, Tenofovir Disoproxil Fumarate, Pegylated interferon alpha2a
Keywords
nucleic acid polymer, REP 2139-Mg, HBV, HDV, cirrhosis, functional cure
Medical subject headings
Hepatitis B, Hepatitis D, Liver Cirrhosis, Esophageal and Gastric Varices, Carcinoma, Hepatocellular, Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • REP 2139-MgDrug

    REP 2139-Mg is the magnesium chelate complex of REP 2139

  • Tenofovir Disoproxil FumarateDrug

    Also called Viread

  • Pegylated interferon alpha2aDrug

    Also called Pegasys

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Expanded access
IDs, dates and publications
ClinicalTrials.gov ID
NCT05683548
Sponsor's protocol ID
RCAP
Acronym
RCAP
Status last verified
Feb 2025
First submitted
4 Jan 2023
Last updated
17 Feb 2025
Results posted
No

Publications

  • 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.

    PubMed 30199230

  • 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.

    PubMed 30771404

  • 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.

    PubMed 32585322

  • 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.

    PubMed 28964701

  • 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.

    PubMed 33553968

  • 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.

    PubMed 32147484

  • Stern 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. 2026 Mar;84(3):531-542. doi: 10.1016/j.jhep.2025.10.029. Epub 2025 Nov 6.

    PubMed 41205755

Questions about this trial

What is this clinical trial studying?

A study testing REP 2139-Mg, Tenofovir Disoproxil Fumarate and Pegylated interferon alpha2a in people with Viral Hepatitis B and Viral Hepatitis D, run by Replicor Inc. at 13 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in France, Austria, Israel, Italy, Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05683548, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025; AzTrials last refreshed its copy on 28 Oct 2026.

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