Replicor Compassionate Access Program (RCAP)

February 13, 2025 updated by: Replicor Inc.

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

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

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.

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
        • Medical University of Vienna
  • France
      • Clichy, France
        • AP-HP Hôpital Beaujon
      • Lille, France
        • CHU Lille
      • Limoges, France
        • CHU-Limoges
      • Marseille, France
        • Höpital Saint-Joseph
      • Montpellier, France
        • CHU de Montpellier
      • Montpellier, France
        • Centre Hospitalier Universitaire De Montpellier
      • Perpignan, France
        • Centre Hospitalier de Perpignan
      • Rennes, France
        • CHU de Rennes
      • Toulouse, France
        • CHU Rangueil, Université Toulouse 3
  • Israel
      • Be'er Sheva, Israel
        • Soroka Medical Center
  • Italy
      • Padua, Italy
        • PADUA UNIVERSITY HOSPITAL
  • Turkey
      • Istanbul, Turkey
        • Koc University Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Replicor Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

January 4, 2023

First Submitted That Met QC Criteria

January 12, 2023

First Posted (Actual)

January 13, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 13, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Decompensated Cirrhosis

Clinical Trials on REP 2139-Mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe