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

NCT02888106 | Completed Phase 2 Results

• 1 other identifier: MYR 203
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 7

Brief 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

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Negative HDV RNA by PCR

  Negativation of HDV RNA by PCR (undetectable HDV RNA) at Week 72 (end of follow-up period)

  72 weeks

Secondary Outcomes (12)

• Percentage of Patients With Negative HDV RNA by PCR

  24 and 48 weeks

• Percentage of Patients With Normalized ALT

  24, 48 and 72 weeks

• Percentage of Patients With Combined Response

  24, 48 and 72 weeks

• Percentage of Patients With HВsAg Response

  24, 48 and 72 weeks

• Percentage of Patients With HBsAg Negativation

  48 and 72 weeks

Study Arms (6)

Arm A

ACTIVE COMPARATOR

PEG IFN alfa-2a 180 µg for 48 weeks

Drug: PEG IFN alfa-2a

Arm B

EXPERIMENTAL

Myrcludex B 2 mg + PEG IFN alfa-2a 180 µg for 48 weeks

Drug: Myrcludex B; Drug: PEG IFN alfa-2a

Arm C

EXPERIMENTAL

Myrcludex B 5 mg + PEG IFN alfa-2a 180 µg for 48 weeks

Drug: Myrcludex B; Drug: PEG IFN alfa-2a

Arm D

EXPERIMENTAL

Myrcludex B 2 mg for 48 weeks

Drug: Myrcludex B

Arm E

EXPERIMENTAL

Myrcludex B 10 mg (10 mg once a day) + PEG-IFN alfa-2a 180 μg during 48 weeks

Drug: Myrcludex B; Drug: PEG IFN alfa-2a

Arm F

EXPERIMENTAL

Myrcludex B 10 mg (5 mg twice a day) + Tenofovir during 48 weeks

Drug: Myrcludex B; Drug: Tenofovir

Interventions

Myrcludex B DRUG

Lyophilised powder for solution for subcutaneous injection

Also known as: Bulevirtide

Arm B; Arm C; Arm D; Arm E; Arm F

PEG IFN alfa-2a DRUG

solution for subcutaneous injection, once per week

Also known as: Pegasys

Arm A; Arm B; Arm C; Arm E

Tenofovir DRUG

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

Also known as: Viread

Arm F

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent form.
• Males and females 18 to 65 years of age (inclusively).
• Patients with chronic hepatitis B (HBeAg-positive or negative) and HBsAg-positive for at least 6 months prior to Screening.
• Positive for anti-HDV antibodies for at least 6 months prior to Screening.
• HDV RNA-positive at Screening.
• ALT ≥ 1 x ULN and \< 10 x ULN.
• The patient agreed to use adequate method of contraception during the study, starting from the time of Informed Consent signing and until completion of the Follow-up Period.

You may not qualify if:

• Intolerance or hypersensitivity to the active ingredient or other components of the study drug Myrcludex B.
• Intolerance or hypersensitivity to interferons alfa, genetically engineered E.coli medications, polyethylene glycol or other components of peginterferon alfa-2a.
• Previous treatment with Myrcludex B (patients with previous exposure to interferon are eligible).
• Therapy with antiviral drugs for chronic viral hepatitis B with delta-agent over the previous 6 months.
• Therapy with anti-tumour agents (including radiotherapy) or immunomodulatory medications (including systemic glucocorticoids) over the previous 6 months.
• The following laboratory test results at Screening:
• Hemoglobin \< 100 g/L
• Leucocytes \< 3000/µL
• Neutrophils \< 1500/µL
• Platelets \< 90000/µL
• Serum creatinine \>1.5 x ULN.
• Total bilirubin \> 34.2 µM/L. Patients with higher total bilirubin may be enrolled upon consultation with the study Medical Monitor, if there is clear evidence that the elevated bilirubin is caused by Gilbert's syndrome.
• Current or previous decompensated liver disease, including coagulopathy, hyperbilirubinemia, hepatic encephalopathy, hypoalbuminaemia, ascites, and oesophageal varices haemorrhage; Child-Pugh score of B/C or ≥6 points.
• HCV or HIV coinfection (patients with anti-HCV antibodies and no HCV RNA at Screening are eligible).
• Hepatocellular carcinoma.

Sponsors & Collaborators

• Hepatera Ltd.: lead

Study Sites (7)

State Budgetary educational institution of higher professional education "South Ural State Medical University" Ministry of healthcare

Chelyabinsk, Russia

Location

State Budgetary Institution of healthcare "Specialized Clinical Infectious Diseases Hospital" Ministry of Health

Krasnodar, Russia

Location

Moscow Regional Research and Clinical Institute

Moscow, 129110, Russia

Location

Federal Budget Institution of Science "Central Research Institute of Epidemiology" of The Federal Service on Customers' Rights Protection and Human Well-being Surveillance

Moscow, Russia

Location

LLC "Clinic of Modern Medicine"

Moscow, Russia

Location

Medical Company "Gepatolog" LLC

Samara, Russia

Location

State Budgetary Institution of healthcare 'Stavropol regional clinical hospital'

Stavropol, Russia

Location

Related Publications (3)

• Lampertico P, Bogomolov PO, Chulanov V, Stepanova T, Morozov V, Allweiss L, Dandri M, Burhenne J, Blank A, Ciesek S, Elsner C, Dittmer U, An Q, Manuilov D, Da BL, Flaherty JF, Urban S, Wedemeyer H. Phase 2 Randomised Study of Bulevirtide as Monotherapy or Combined With Peg-IFNalpha-2a as Treatment for Chronic Hepatitis Delta. Liver Int. 2025 Feb;45(2):e70008. doi: 10.1111/liv.70008.

  PMID: 39853842 DERIVED

• Asselah T, Lampertico P, Aleman S, Bourliere M, Streinu-Cercel A, Bogomolov P, Morozov V, Stepanova T, Lazar S, Manuilov D, Mercier RC, Tseng S, Ye L, Flaherty JF, Osinusi A, Da BL, Chee GM, Lau AH, Brunetto MR, Wedemeyer H. Bulevirtide Monotherapy Is Safe and Well Tolerated in Chronic Hepatitis Delta: An Integrated Safety Analysis of Bulevirtide Clinical Trials at Week 48. Liver Int. 2025 Apr;45(4):e16174. doi: 10.1111/liv.16174. Epub 2024 Dec 8.

  PMID: 39648559 DERIVED

• Allweiss L, Volmari A, Suri V, Wallin JJ, Flaherty JF, Manuilov D, Downie B, Lutgehetmann M, Bockmann JH, Urban S, Wedemeyer H, Dandri M. Blocking viral entry with bulevirtide reduces the number of HDV-infected hepatocytes in human liver biopsies. J Hepatol. 2024 Jun;80(6):882-891. doi: 10.1016/j.jhep.2024.01.035. Epub 2024 Feb 8.

  PMID: 38340811 DERIVED

MeSH Terms

Interventions

myrcludex-B; bulevirtide; peginterferon alfa-2a; Tenofovir

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Yana Deloveri
• Organization: Hepatera LLC

deloveri@hepatera.ru

+7 495 762 52 53

Study Officials

• Pavel Bogomolov, PhD

  Moscow Regional Research and Clinical Institute (MONIKI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, Open-label, Randomized, Comparative, parallel-arm phase II study

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: September 2, 2016
• Study Start: April 1, 2016
• Primary Completion: November 22, 2019
• Study Completion: October 30, 2020
• Last Updated: April 30, 2021
• Results First Posted: February 25, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (7)