Compassionate Access

Replicor Compassionate Access Program

The Replicor Compassionate use Access Program (RCAP, NCT05683548) is providing access to REP 2139-Mg for patients with chronic hepatitis B (HBV) and hepatitis delta (HDV) with urgent medical need including:

  1. Previous virologic or biochemical failure to pegIFN, bulevirtide and lonafarnib or combinations thereof.
  2. Patients with HBV / HDV decompensated cirrhosis.

 

The goals of this compassionate access program are:

  1. Provide urgently needed salvage therapy for HBV / HDV patients with compensated or decompensated cirrhosis.
  2. Expand access to REP 2139-Mg to investigators worldwide.
  3. Demonstrate the safety, tolerability, and convenience of a once-weekly subcutaneous administration of REP 2139-Mg.
  4. Expand the safety envelope of REP -2139-Mg in advanced liver disease, even in combination with pegylated interferon.
  5. Replicate the antiviral effects of REP 2139-Mg against HBV and HDV infection observed in previous clinical trials.

 

This compassionate use program is currently slated to provide access to 36 courses of REP 2139-Mg therapy.   Data from these compassionate use cases will serve as bridging data enabling transition to subcutaneous injection for REP 2139-Mg in upcoming phase II studies.

Compassionate access to REP 2139-Mg is only provided to interested and qualified investigators and following approval of individual cases by Replicor and under applicable regulatory statutes.

Regular updates on patients enrolled in the RCAP will be presented at all major liver disease and HBV / HDV conferences.

The following institutions are currently participating in the RCAP:

France:

  • Hôpital Saint-Joseph, Marseille
  • Centre Hospitalier Universitaire (CHU) de Limoges, Limoges
  • AP-HP Hôpital Beaujon, Clichy
  • CHU de Rennes, Rennes
  • CHU Rangueil, Université Toulouse 3, Toulouse
  • CHU de Montpellier, Montpellier
  • Centre Hospitalier de Perpignan, Perpignan
  • CHU Lille, Lille

Israel:

  • Soroka Medical Center, Beersheba

Austria:

  • Medical University of Vienna, Vienna

Italy:

  • Padua University Hospital, Padua.

Turkey:

  • Koç University Medical School, Istanbul

For more information or to enquire about compassionate access to REP 2139-Mg (qualified investigators only), please contact Replicor at info@replicor.com.