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Replicor Compassionate Access Program

NCT05683548 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2025-02-17

No results posted yet for this study

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

Conditions

  • Viral Hepatitis B
  • Viral Hepatitis D
  • Cirrhosis, Liver
  • Decompensated Cirrhosis
  • Ascites Hepatic
  • Varices, Esophageal
  • Hepatocellular Carcinoma

Interventions

DRUG

REP 2139-Mg

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

DRUG

Tenofovir Disoproxil Fumarate

DRUG

Pegylated interferon alpha2a

Sponsors & Collaborators

  • Replicor Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • Austria
  • France
  • Israel
  • Italy
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05683548 on ClinicalTrials.gov