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A Long Term Follow-up Study of Patients From the REP 301 Protocol

NCT02876419 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 11

Last updated 2020-10-06

No results posted yet for this study

Summary

The REP 301 treatment protocol involved the treatment of patients with chronic hepatitis B / hepatitis D co-infection with two agents: REP 2139-Ca and pegylated interferon (peg-IFN). In this protocol, similar reduction/clearance of serum HBsAg and improved response to immunotherapy were observed in addition to clearance of serum HDV RNA. The REP 301 protocol was designed to include a 24 week follow-up period after treatment, however given the strong antiviral response against HBV and HDV infection in these patients, it is now important to extend the follow-up period in these patients to monitor over a longer period after treatment the safety and efficacy combined REP 2139-Ca / peg-IFN treatment in patients in the REP 301 protocol.

Conditions

  • Hepatitis B, Chronic
  • Hepatitis D, Chronic

Sponsors & Collaborators

  • Replicor Inc.

    lead INDUSTRY

Principal Investigators

  • Victor Pantea, MD · Infectious Clinical Hospital (n.a. Toma Ciorba)

Eligibility

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

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2019-11-13
Completion
2019-12-31

Countries

  • Moldova

Study Locations

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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 NCT02876419 on ClinicalTrials.gov