At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 12 enrolled

Drug / intervention

REP 2139-Ca +2 moredrug

Likely dose

REP 2139-Ca 500mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02646189

NCT02646189Phase 2Completed

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

Replicor Inc.·interventional·Posted Jan 5, 2016·Updated Jan 5, 2016

In Brief

A Phase 2 clinical trial evaluating REP 2139-Ca, Zadaxin, and 1 other intervention for Hepatitis B, Chronic. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHepatitis B, Chronic

CountriesBangladesh

Collaborators--

Timeline

Phase 2CompletedFinished

201220132014201520162017201820192020202120222023202420252026

Enrollment StartAug 2011

Primary CompletionAug 2013

First PostedJan 2016

TodayJul 2026

First PostedJan 5, 2016

Enrollment StartAug 1, 2011

Primary CompletionAug 1, 2013

TodayJul 2, 2026

Enrollment to primary: 2 yearsPosted 10.5 years ago

Interventions

REP 2139-Cadrug

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

Zadaxindrug

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

Pegasysdrug

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