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REP 2139-Mg and REP 2165-Mg Combination Therapy in Chronic Hepatitis B Infection

NCT02565719 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-09-10

No results posted yet for this study

Summary

NAPs have been previously shown to clear serum hepatitis B virus surface antigen (HBsAg) both preclinically (in duck HBV infected ducks) and in human patients. REP 2139-Ca mediated HBsAg clearance acts synergistically with immunotherapeutic agent pegylated interferon-alpha 2a to restore host immunological control of HBV infection. REP 2165 is a version of REP 2139 which has been shown preclinically to retain antiviral activity with lower accumulation in the liver.

Both REP 2139 and REP 2165 used in this protocol are formulated as magnesium chelate complexes, which improve their administration tolerability. This open label, randomized and controlled study will examine the safety and efficacy of REP 2139-Mg and REP 2165-Mg therapy in patients with HBeAg negative chronic hepatitis B when used in combination with tenofovir disoproxil fumarate and pegylated interferon alpha-2a.

Conditions

Interventions

DRUG

REP 2139-Mg

REP 2139-Mg = magnesium chelate complex of REP 2139

DRUG

Pegasys

immunotherapy

DRUG

Viread

HBV RT polymerase inhibitor

DRUG

REP 2165-Mg

REP 2165-Mg = magnesium chelate complex of REP 2165

Sponsors & Collaborators

  • Replicor Inc.

    lead INDUSTRY

Principal Investigators

  • Victor Pantea, M.D. · Infectious Diseases Department, State University of Medicine and Pharmacy, Infectious Clinical Hospital (n.a. Toma Clorba), Chisinau, Moldova, Republic of 2004

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2019-05-31
Completion
2019-05-31

Countries

  • Moldova

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 NCT02565719 on ClinicalTrials.gov