Chronic Viral Hepatitis B With Delta-agentPhase 2NCT02888106
Myrcludex B in Combination With Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients With Chronic Viral Hepatitis B With Delta-agent
A Phase 2 study testing Myrcludex B, PEG IFN alfa-2a and Tenofovir in people with Chronic Viral Hepatitis B With Delta-agent, run by Hepatera Ltd. at 7 sites in Russia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Viral Hepatitis B With Delta-agent
- What is being tested?
- Myrcludex B, PEG IFN alfa-2a and Tenofovir
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 7 sitesRussia
- Study dates
- Apr 2016to 30 Oct 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 32Show fewer
- 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.
- Signs of drug- or alcohol-induced liver disease or any other medical conditions associated with chronic liver disease (e.g. autoimmune hepatitis, hemochromatosis, thalassaemia, alcoholic hepatitis, toxic liver disease).
- Contraindications for liver biopsy.
- Concurrent malignancy (current diagnosed or suspected malignancy; risk of a previous malignancy recurrence).
- Severe decompensated cardiovascular diseases, including unstable and poorly controlled conditions, over 6 months before Screening.
- History of poorly controlled thyroid conditions or clinically significant signs of thyroid dysfunction at Screening.
- Previous or current severe renal failure or significant renal dysfunction at Screening.
- Previous or current chronic pulmonary disease with respiratory distortion at Screening.
- Previous or current severe retinopathy, significant ophthalmology disorders associated with diabetes mellitus or hypertension.
- Previous or current severe psychiatric disorders at Screening (e.g. severe depressions, suicidal attempts, severe neuroses or cognitive disorders).
- Previous or current endocrine disorders (hypoglycaemia, hyperglycaemia, diabetes mellitus) that are not adequately controlled at Screening.
- History of visceral organ transplantation.
- Signs of drug and/or alcohol dependence (80 g of alcohol/day for men and 40 g of alcohol/day for women) within 1 year before Screening.
- History of immune disorders (e.g. idiopathic thrombocytopenic purpura, lupus erythematosus, sclerodermia, severe psoriasis, rheumatoid arthritis).
- Need for concomitant use of glucocorticoids or myelotoxic agents.
- Participation in another clinical study within 30 days prior to enrollment into this study.
- Pregnant or breast-feeding females.
- Any other condition that, in the opinion of Investigator, precludes the patient from taking part in this study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Russia7 sites
State Budgetary educational institution of higher professional education "South Ural State Medical University" Ministry of healthcare
Chelyabinsk
State Budgetary Institution of healthcare "Specialized Clinical Infectious Diseases Hospital" Ministry of Health
Krasnodar
Moscow Regional Research and Clinical Institute
Moscow, 129110
Federal Budget Institution of Science "Central Research Institute of Epidemiology" of The Federal Service on Customers' Rights Protection and Human Well-being Surveillance
Moscow
LLC "Clinic of Modern Medicine"
Moscow
Medical Company "Gepatolog" LLC
Samara
State Budgetary Institution of healthcare 'Stavropol regional clinical hospital'
Stavropol
About this study
Official title: 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
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
Read the 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
- Being tested
- Myrcludex B, PEG IFN alfa-2a, Tenofovir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myrcludex BDrug
Also called Bulevirtide
Lyophilised powder for solution for subcutaneous injection
PEG IFN alfa-2aDrug
Also called Pegasys
solution for subcutaneous injection, once per week
TenofovirDrug
Also called Viread
Film-coated tablets, 300 mg, per os, once daily
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | PEG IFN alfa-2a 180 µg for 48 weeks Receives: Drug: PEG IFN alfa-2a |
| Arm B | Experimental | Myrcludex B 2 mg + PEG IFN alfa-2a 180 µg for 48 weeks Receives: Drug: Myrcludex B; Drug: PEG IFN alfa-2a |
| Arm C | Experimental | Myrcludex B 5 mg + PEG IFN alfa-2a 180 µg for 48 weeks Receives: Drug: Myrcludex B; Drug: PEG IFN alfa-2a |
| Arm D | Experimental | Myrcludex B 2 mg for 48 weeks Receives: Drug: Myrcludex B |
| Arm E | Experimental | Myrcludex B 10 mg (10 mg once a day) + PEG-IFN alfa-2a 180 μg during 48 weeks Receives: Drug: Myrcludex B; Drug: PEG IFN alfa-2a |
| Arm F | Experimental | Myrcludex B 10 mg (5 mg twice a day) + Tenofovir during 48 weeks Receives: Drug: Myrcludex B; Drug: Tenofovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 72 weeks
Secondary outcomes (12)
Percentage of Patients With Negative HDV RNA by PCR
Percentage of patients with negative HDV RNA by PCR (undetectable HDV RNA) at Weeks 24 and 48
Measured: 24 and 48 weeks
Percentage of Patients With Normalized ALT
Percentage of patients with normalized ALT at Weeks 24, 48 and 72. ALT normalisation was defined as having an ALT value within the normal range (≤31 U/L for females and ≤41 U/L for males)
Measured: 24, 48 and 72 weeks
Percentage of Patients With Combined Response
Combined response is defined as negative HDV RNA and ALT normalization at Weeks 24, 48, and 72. The criteria for combined response were HDV RNA value below LLoD (where LLoD=10 IU/ml) and ALT within normal range (≤31 U/L for females and ≤41 U/L for males)
Measured: 24, 48 and 72 weeks
Percentage of Patients With HВsAg Response
HВsAg response was defined as HBsAg negativation or > 1 log10 IU/mL decline from baseline.
Measured: 24, 48 and 72 weeks
Percentage of Patients With HBsAg Negativation
Undetectable HВsAg with appearance of HbsAg antibodies or without it.
Measured: 48 and 72 weeks
Percentage of Patients With Negative HBV DNA by PCR
Percentage of patients with undetectable HBV DNA by PCR at Weeks 24, 48 and 72
Measured: 24, 48 and 72 weeks
The Intensity of Liver Fibrosis Based on Results of Transient Elastometry of Liver at Weeks 48 and 72.
Change in liver stiffness and intensity of liver fibrosis based on results of transient elastometry of liver at weeks 48 and 72.
Measured: 48 and 72 weeks
Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment
Change (improvement/ worsening) in fibrosis and histological activity stage according to the liver biopsy study results from baseline to post-treatment Liver fibrosis was evaluated by histological staging systems with stage 0 corresponding to absence of fibrosis and with the highest score (the last stage in all systems) corresponding to cirrhosis.
Improvement is defined as a decrease of at least 1 point in histological staging systems; worsening is defined as an increase of at least 1 point.
Data should be interpreted with caution due to low number of paired biopsies available.
Measured: 72 weeks
Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region).
Molecular analyses of relative HDV RNA expression, relative HBV pregenomic expression, relative total HBV RNA expression (X region), relative HBV RNA expression (S region) from baseline to post-treatment.
*Biopsy post treatment performed at Week 48 for arm D:MXB 2mg and arm F:MXB 5mg bid + Tenofovir, and performed at Week 72 for arms A:PEG-IFN, B:MXB 2mg + PEG-IFN, C:MXB 5mg + PEG-IFN and arm E:MXB 10mg + PEG-IFN.
Measured: 48 and 72 weeks
Change in Molecular Analyses of Total HBV DNA (X Region) Copies/Cell, HBV DNA (S Region) Copies/Cell, cccDNA Copies/Cell From Baseline to Post-treatment.
Molecular analyses of total HBV DNA (X region) copies/cell, HBV DNA (S region) copies/cell, cccDNA copies/cell from baseline to post-treatment.
*Biopsy post treatment performed at Week 48 for arm D:MXB 2mg and arm F:MXB 5mg bid + Tenofovir, and performed at Week 72 for arms A:PEG-IFN, B:MXB 2mg + PEG-IFN, C:MXB 5mg + PEG-IFN and arm E:MXB 10mg + PEG-IFN.
Measured: 48 and 72 weeks
Change in Molecular Analysis of HDAg Positive Hepatocytes (%) From Baseline to Post-treatment
Molecular analysis of HDAg positive Hepatocytes (percentage of HDAg positive Hepatocytes) from baseline to post-treatment.
*Biopsy post treatment performed at Week 48 for arm D:MXB 2mg and arm F:MXB 5mg bid + Tenofovir, and performed at Week 72 for arms A:PEG-IFN, B:MXB 2mg + PEG-IFN, C:MXB 5mg + PEG-IFN and arm E:MXB 10mg + PEG-IFN.
Measured: 48 and 72 weeks
Change in the Gene Expression Analyses From Baseline to Post-treatment
Change in the gene expression analyses of CXCL10, NTCP, CYP7A1, ISG15, MX1, OAS, HLA-E, TAP1 and USP18 from baseline to post-treatment.
Biopsy post treatment performed at Week 48 for arm D:MXB 2mg and arm F:MXB 5mg bid + Tenofovir, and performed at Week 72 for arms A:PEG-IFN, B:MXB 2mg + PEG-IFN, C:MXB 5mg + PEG-IFN and arm E:MXB 10mg + PEG-IFN.
Measured: Weeks 48 - 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startApr 2016
- Primary completion22 Nov 2019
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Viral Hepatitis B With Delta-agentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, Open-label, Randomized, Comparative, parallel-arm phase II study
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hepatera Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pavel Bogomolov, PhD, Principal investigator, Moscow Regional Research and Clinical Institute (MONIKI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888106
- Sponsor's protocol ID
- MYR 203
- Status last verified
- Mar 2021
- First submitted
- 30 Aug 2016
- Last updated
- 30 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 39853842Asselah 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.
PubMed 39648559Allweiss 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.
PubMed 38340811
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02888106
- Acronym / sponsor ID
- MYR 203
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hepatera Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2016 (actual)
- Primary completion
- 22 Nov 2019 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 2 Sep 2016 (estimated)
- Results
- Posted 25 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Multicenter, Open-label, Randomized, Comparative, parallel-arm phase II study
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: PEG IFN alfa-2aPEG IFN alfa-2a 180 µg for 48 weeks |
| Arm B | Experimental | Drug: Myrcludex B, Drug: PEG IFN alfa-2aMyrcludex B 2 mg + PEG IFN alfa-2a 180 µg for 48 weeks |
| Arm C | Experimental | Drug: Myrcludex B, Drug: PEG IFN alfa-2aMyrcludex B 5 mg + PEG IFN alfa-2a 180 µg for 48 weeks |
| Arm D | Experimental | Drug: Myrcludex BMyrcludex B 2 mg for 48 weeks |
| Arm E | Experimental | Drug: Myrcludex B, Drug: PEG IFN alfa-2aMyrcludex B 10 mg (10 mg once a day) + PEG-IFN alfa-2a 180 μg during 48 weeks |
| Arm F | Experimental | Drug: Myrcludex B, Drug: TenofovirMyrcludex B 10 mg (5 mg twice a day) + Tenofovir during 48 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (32 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myrcludex BAlso: BulevirtideLyophilised powder for solution for subcutaneous injection | Drug | Arm B, Arm C, Arm D, Arm E, Arm F |
| PEG IFN alfa-2aAlso: Pegasyssolution for subcutaneous injection, once per week | Drug | Arm A, Arm B, Arm C, Arm E |
| TenofovirAlso: VireadFilm-coated tablets, 300 mg, per os, once daily | Drug | Arm F |
Primary outcome
Percentage of Patients With Negative HDV RNA by PCR
Time frame: 72 weeks
Negativation of HDV RNA by PCR (undetectable HDV RNA) at Week 72 (end of follow-up period)
12 secondary outcomes
Percentage of Patients With Negative HDV RNA by PCR
Time frame: 24 and 48 weeks
Percentage of Patients With Normalized ALT
Time frame: 24, 48 and 72 weeks
Percentage of Patients With Combined Response
Time frame: 24, 48 and 72 weeks
Percentage of Patients With HВsAg Response
Time frame: 24, 48 and 72 weeks
Percentage of Patients With HBsAg Negativation
Time frame: 48 and 72 weeks
Percentage of Patients With Negative HBV DNA by PCR
Time frame: 24, 48 and 72 weeks
The Intensity of Liver Fibrosis Based on Results of Transient Elastometry of Liver at Weeks 48 and 72.
Time frame: 48 and 72 weeks
Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment
Time frame: 72 weeks
Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region).
Time frame: 48 and 72 weeks
Change in Molecular Analyses of Total HBV DNA (X Region) Copies/Cell, HBV DNA (S Region) Copies/Cell, cccDNA Copies/Cell From Baseline to Post-treatment.
Time frame: 48 and 72 weeks
Change in Molecular Analysis of HDAg Positive Hepatocytes (%) From Baseline to Post-treatment
Time frame: 48 and 72 weeks
Change in the Gene Expression Analyses From Baseline to Post-treatment
Time frame: Weeks 48 - 72
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39853842Lampertico 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.
- Derived from this study: PubMed 39648559Asselah 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.
- Derived from this study: PubMed 38340811Allweiss 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pavel Bogomolov, PhD principal investigator
Moscow Regional Research and Clinical Institute (MONIKI)
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Myrcludex B, PEG IFN alfa-2a and Tenofovir in people with Chronic Viral Hepatitis B With Delta-agent, run by Hepatera Ltd. at 7 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients With Negative HDV RNA by PCR (time frame: 72 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02888106, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.