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Therapeutic Safety and Efficacy of REP 2139 (REP 9AC') in HBV Infected Patients

NCT02646189 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2016-01-05

No results posted yet for this study

Summary

REP 9AC (REP 2055) is a nucleic acid polymer (NAP) with entry and post-entry antiviral activity against duck hepatitis B virus (DHBV) infection. REP 2055 has been shown to have potent therapeutic effect against established DHBV infection in vivo

REP 2055 was additionally shown to have significant antiviral effects in patients with chronic HBV infection in the previous REP 101 study. REP 2139 is a version of REP 2055 designed for improved administration tolerability and stability.

The safety and antiviral activity REP 2139, first in monotherapy and then in combination with immunotherapy in patients with chronic HBV infection will be assessed in the REP 102 protocol.

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

REP 2139-Ca

REP 2139-Ca is administered weekly at 250 or 500mg doses by slow IV infusion.

DRUG

Zadaxin

Zadaxin is administered twice weekly (1.6mg) by subcutaneous injection

DRUG

Pegasys

Pegasys in administered once weekly by subcutaneous injection with dose escalation to 180ug / week.

Sponsors & Collaborators

  • Replicor Inc.

    lead INDUSTRY

Principal Investigators

  • Mamun Al-Mahtab, MD · Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • Bangladesh

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 NCT02646189 on ClinicalTrials.gov