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Myrcludex B in Combination With Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients With Chronic Viral Hepatitis B With Delta-agent

NCT02888106 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2021-04-30

Study results available
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Summary

Randomised, Comparative, Parallel-Arm Study to Assess Efficacy and Safety of Myrcludex B in Combination with Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients with Chronic Viral Hepatitis B with Delta-agent

Conditions

  • Chronic Viral Hepatitis B With Delta-agent

Interventions

DRUG

Myrcludex B

Lyophilised powder for solution for subcutaneous injection

DRUG

PEG IFN alfa-2a

solution for subcutaneous injection, once per week

DRUG

Tenofovir

Film-coated tablets, 300 mg, per os, once daily

Sponsors & Collaborators

  • Hepatera Ltd.

    lead INDUSTRY

Principal Investigators

  • Pavel Bogomolov, PhD · Moscow Regional Research and Clinical Institute (MONIKI)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2019-11-22
Completion
2020-10-30

Countries

  • Russia

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 NCT02888106 on ClinicalTrials.gov