NCT02888106

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

A Multicenter, Open-label, Randomised, Comparative, Parallel-Arm, Phase II 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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Hepatera Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a multicenter, open-label, randomised, comparative, active-controlled parallel-arm phase II study. The study will be conducted in Russia. The aim of this study is to explore the safety and efficacy of treatment with Myrcludex B used as a monotherapy and in combination with PEG-IFNα and Tenofovir compared to monotherapy with PEG-IFNα in patients with chronic viral hepatitis B with delta-agent, based on the achievement of undetectable viral load at the end of the follow-up period 6 months (24 weeks) after the end of treatment. The study is also aimed at investigating immunogenicity of Myrcludex B and the drug pharmacokinetics when used in combination with PEG IFN alfa-2a and with Tenofovir. It is planned to screen 110 patients, and 90 patients will be randomised in equal numbers into six treatment arms. * Arm A (n=15): PEG IFN alfa-2a 180 µg for 48 weeks * Arm B (n=15): Myrcludex B 2 mg + PEG IFN alfa-2a 180 µg for 48 weeks * Arm C (n=15): Myrcludex B 5 mg + PEG IFN alfa-2a 180 µg for 48 weeks * Arm D (n=15): Myrcludex B 2 mg for 48 weeks * Arm E (n=15): Myrcludex B 10 mg (10 mg once a day)+ PEG IFN alfa-2a 180 µg for 48 weeks * Arm F (n=15): Myrcludex B 10 mg (5 mg twice a day)+ Tenofovir for 48 weeks

Conditions

• Chronic Viral Hepatitis B With Delta-agent

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-04-01
• Primary completion: 2019-11-22
• Completion: 2020-10-30
• First posted: 2016-09-02
• Last updated: 2021-04-30
• Results posted: 2021-02-25

Locations

7 sites across 1 country: Russia