Chronic Hepatitis D Infection With Hepatitis BPhase 2NCT03546621
A Multicenter, Open-label, Randomized Clinical Study to Assess Efficacy and Safety of 3 Doses of Myrcludex B for 24 Weeks in Combination With Tenofovir Compared to Tenofovir Alone to Suppress HBV Replication in Patients With Chronic Hepatitis D
A Phase 2 study testing Myrcludex B, Myrcludex-B and Tenofovir in people with Chronic Hepatitis D Infection With Hepatitis B, run by Hepatera Ltd. at 15 sites in 2 countries.
Trial summary
This is a multicenter, open-label, randomized clinical trial to Assess Efficacy and Safety of 3 Doses of Myrcludex B for 24 Weeks in Combination with Tenofovir Compared to Tenofovir Alone to Suppress HBV Replication in Patients with Chronic Hepatitis D Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis D Infection With Hepatitis B
- What is being tested?
- Myrcludex B, Myrcludex-B and Tenofovir
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 16 Feb 2016to 31 Jan 2018
- 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
- Age from 18 to 65 years inclusively at the time of signing Informed Consent Form.
- Positive serum HBsAg for at least 6 months before Screening.
- Positive serum anti-HDV antibody for at least 6 months before screening.
- Positive PCR results for serum HDV RNA at Screening.
- Patients with liver cirrhosis, irrespective of previous interferon treatment .
- Patients without liver cirrhosis, who failed prior interferon treatment or for whom, in the opinion of the Investigator, such treatment is currently contraindicated (including history of interferon intolerance) .
Show all 16Show fewer
- Alanine aminotransferase level >1 x ULN, but less than 10 x ULN.
- Previous nucleotide/nucleoside analogue treatment within at least 12 weeks prior to the planned start of study treatment or subject's willingness to take tenofovir for at least 12 weeks prior to the planned start of study treatment.
- Negative urine pregnancy test for females of childbearing potential.
- Inclusion criteria for female subjects:
- Postmenopausal for at least 2 years, or
- Surgically sterile (total hysterectomy or bilateral oophorectomy, bilateral tubal ligation, staples, or another type of sterilization), or
- Abstinence from heterosexual intercourse throughout the study, or
- Willingness to use highly effective contraception throughout the study and for 3 months after the last dose of the study medication.
- Male and female subjects must agree to use a highly effective contraception throughout the study and for 3 months after the last dose of the study medication.
- Male subjects must agree not to donate sperm throughout the study and for 3 months after the last dose of the study medication.
Who cannot join
- Child-Pugh score of B-C or over 6 points.
- HCV or HIV coinfection. Subjects with anti-HCV antibodies can be enrolled, if screening HCV RNA test is negative.
- Creatinine clearance <60 mL/min.
- Total bilirubin ≥ 2mg/dL. Patients with higher total bilirubin values may be included after the consultation with the Study's Medical Monitor, if such elevation can be clearly attributed to Gilbert's syndrome associated with low-grade hyperbilirubinemia.
- Any previous or current malignant neoplasms, including hepatic carcinoma.
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
Russia11 sites
State Budgetary educational institution of higher professional education "South Ural State Medical University" Ministry of healthcare
Chelyabinsk
State Autonomous Healthcare Institution "Republican Clinical Infectious Diseases Hospital named after Prof. A.F. Agafonov "(SAHI RCID)
Kazan'
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
Moscow Regional Research Clinical Institute n.a. M.F. Vladimirskiy
Moscow
State Budget Health Institution of Moscow "Infectious Clinical Hospital No. 1 of the Moscow Healthcare Department"
Moscow
State Budgetary Healthcare Institution "Moscow Clinical Scientific and Practical Center of the Department of Public Health of Moscow"
Moscow
State Budgetary Educational Institution of Higher Professional Education "Novosibirsk State Medical University" of the Ministry of Health of the Russian Federation
Novosibirsk
Medical Company "Hepatolog"
Samara
Stavropol Regional Clinical Hospital
Stavropol
State Budgetary institution of the Republic of Sakha (Yakutia) "Yakutsk Clinical Hospital"
Yakutsk
Germany4 sites
Ifi-Institut für interdisziplinäre Medizin an der Asklepios Klinik St. Georg
Hamburg
Universitätsklinikum Hamburg-Eppendorf Medizinische Klinik Studienambulanz Hepatologie
Hamburg
Klinik für Gastroenterologie, Hepatologie und Endokrinologie, Medizinische Hochschule Hannover
Hanover
UniversitätsKlinikum Heidelberg - Medizinische Klinik, Abteilung Klinische Pharmakologie & Pharmakoepidemiologie
Heidelberg
About this study
This is a multicenter, open-label, randomized clinical trial to Assess Efficacy and Safety of 3 Doses of Myrcludex B for 24 Weeks in Combination with Tenofovir Compared to Tenofovir Alone to Suppress HBV Replication in Patients with Chronic Hepatitis D
Read the detailed description
This is a multicenter, open-label, randomised, phase II study.
The study will be conducted in Russia and Germany. The study is designed to evaluate the benefit of 3 MXB doses versus observation in patients on background therapy with tenofovir, suffering from hepatitis delta with very limited therapeutic options; the patients will be randomized 1:1:1:1 into 3 treatment arms and an observation arm. Patients with compensated cirrhosis at screening will be stratified to allow similar distribution into each treatment arm. If patients were not receiving treatment with nucleoside/nucelotide analogue, the comparator/background drug will be initiated after the eligibility confirmation, for 12 weeks prior to randomization visit; patients who previously received tenofovir will continue the dosing; patients on different nucleoside/nucleotide analogue will be switched to tenofovir. Observation is considered an adequate control group, as daily placebo injections for 24 weeks are regarded not feasible and ethically questionable.
It is planned to screen 200 patients, and 120 patients will be randomised into four treatment arms in the 1:1:1:1 ratio.
- Arm A (30 patients): Myrcludex B, 2 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
- Arm B (30 patients): Myrcludex B, 5 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
- Arm C (30 patients): Myrcludex B, 10 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
- Arm D (30 patients): tenofovir treatment for 48 weeks.
- Being tested
- Myrcludex B, Myrcludex-B, Tenofovir
- Keywords
- Hepatitis D
- Medical subject headings
- Hepatitis D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myrcludex BDrug
2 mg, once daily, subcutaneously
Myrcludex-BDrug
5 mg, once daily, subcutaneously
Myrcludex-BDrug
10 mg, once daily, subcutaneously
TenofovirDrug
Also called Viread
tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Myrcludex B, 2 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy. Receives: Drug: Myrcludex B; Drug: Tenofovir |
| Arm B | Experimental | Myrcludex B, 5 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy. Receives: Drug: Myrcludex-B; Drug: Tenofovir |
| Arm C | Experimental | Myrcludex B, 10 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy. Receives: Drug: Myrcludex-B; Drug: Tenofovir |
| Arm D | Active comparator | tenofovir treatment for 48 weeks Receives: Drug: Tenofovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
HDV RNA Response at Week 24
HDV RNA negativation or decrease by ≥2 log10 from baseline to Week 24
Measured: 24 weeks
Secondary outcomes (8)
Durability of HDV RNA Response
Durability of HDV RNA response to 24 weeks post treatment
Measured: 48 weeks
Combined Response: HDV RNA Response and Normal ALT at Treatment Week 24
Combined response: HDV RNA negativation or ≥2 log decline and normal ALT at treatment week 24
Measured: 24 weeks
Changes in ALT Values
Changes in ALT values at Week 24 and Week 48 compared to baseline.
Measured: 24 and 48 weeks
Change (Absence of Increase) in Fibrosis Marker
Change (absence of increase) in fibrosis marker: serum alpha-2-macroglobulin at Week 24 and Week 48 compared to baseline
Measured: 24 and 48 weeks
Change in Hepatitis B Surface Antigen
Changes in hepatitis B surface antigen (HBsAg) (defined as decline in HBsAg levels, disappearance of HBsAg and HBsAg seroconversion to anti-HBsAg) at week 24 and week 48 compared to baseline
Measured: 24 and 48 weeks
Change in HBV DNA Levels at Week 24 and Week 48 Compared to Baseline
Change in hepatitis B virus (HBV) DNA levels at Week 24 and Week 48 compared to baseline.
Measured: 24 and 48 weeks
Absence of a Fibrosis Progression According to the Findings of Transient Elastometry
Decrease in liver stiffness and absence of a fibrosis progression according to the findings of transient elastometry (fibroscan) at week 24 compared to baseline
Measured: 24 weeks
Number of Participants With Improvement of Histological Findings According to the Liver Biopsy Results
Change (improvement/ worsening) in fibrosis and histological activity stage according to the liver biopsy study results at week 24 compared to baseline.
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: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start16 Feb 2016
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
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 Hepatitis D Infection With Hepatitis BStudies 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
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hepatera Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Data Matrix Solutions
- Responsible party
- Sponsor
- Investigators
- Heiner Wedemeyer, MD,PhD, Principal investigator, Dept. of Gastroenterology, Hepatology and Endocrinology Medizinische Hochschule Hannover
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546621
- Sponsor's protocol ID
- MYR 202
- Status last verified
- Apr 2021
- First submitted
- 23 May 2018
- Last updated
- 10 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38340811Hollnberger J, Liu Y, Xu S, Chang S, Martin R, Manhas S, Aeschbacher T, Han B, Yazdi T, May L, Han D, Shornikov A, Flaherty J, Manuilov D, Suri V, Asselah T, Lampertico P, Wedemeyer H, Aleman S, Richards C, Mateo R, Maiorova E, Cihlar T, Mo H, Urban S. No virologic resistance to bulevirtide monotherapy detected in patients through 24 weeks treatment in phase II and III clinical trials for chronic hepatitis delta. J Hepatol. 2023 Sep;79(3):657-665. doi: 10.1016/j.jhep.2023.04.027. Epub 2023 Apr 27.
PubMed 37120031Wedemeyer H, Schoneweis K, Bogomolov P, Blank A, Voronkova N, Stepanova T, Sagalova O, Chulanov V, Osipenko M, Morozov V, Geyvandova N, Sleptsova S, Bakulin IG, Khaertynova I, Rusanova M, Pathil A, Merle U, Bremer B, Allweiss L, Lempp FA, Port K, Haag M, Schwab M, Zur Wiesch JS, Cornberg M, Haefeli WE, Dandri M, Alexandrov A, Urban S. Safety and efficacy of bulevirtide in combination with tenofovir disoproxil fumarate in patients with hepatitis B virus and hepatitis D virus coinfection (MYR202): a multicentre, randomised, parallel-group, open-label, phase 2 trial. Lancet Infect Dis. 2023 Jan;23(1):117-129. doi: 10.1016/S1473-3099(22)00318-8. Epub 2022 Sep 13.
PubMed 36113537
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Randomized Clinical Study to Assess Efficacy and Safety of 3 Doses of Myrcludex B for 24 Weeks in Combination With Tenofovir Compared to Tenofovir Alone to Suppress HBV Replication in Patients With Chronic Hepatitis D
- ClinicalTrials.gov ID
- NCT03546621
- Acronym / sponsor ID
- MYR 202
- Keywords
- Hepatitis D
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hepatera Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Data Matrix Solutions
- Study start
- 16 Feb 2016 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 6 Jun 2018 (actual)
- Results
- Posted 30 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, open-label, randomized clinical trial to Assess Efficacy and Safety of 3 Doses of Myrcludex B for 24 Weeks in Combination with Tenofovir Compared to Tenofovir Alone to Suppress HBV Replication in Patients with Chronic Hepatitis D
Detailed description
This is a multicenter, open-label, randomised, phase II study.
The study will be conducted in Russia and Germany. The study is designed to evaluate the benefit of 3 MXB doses versus observation in patients on background therapy with tenofovir, suffering from hepatitis delta with very limited therapeutic options; the patients will be randomized 1:1:1:1 into 3 treatment arms and an observation arm. Patients with compensated cirrhosis at screening will be stratified to allow similar distribution into each treatment arm. If patients were not receiving treatment with nucleoside/nucelotide analogue, the comparator/background drug will be initiated after the eligibility confirmation, for 12 weeks prior to randomization visit; patients who previously received tenofovir will continue the dosing; patients on different nucleoside/nucleotide analogue will be switched to tenofovir. Observation is considered an adequate control group, as daily placebo injections for 24 weeks are regarded not feasible and ethically questionable.
It is planned to screen 200 patients, and 120 patients will be randomised into four treatment arms in the 1:1:1:1 ratio.
- Arm A (30 patients): Myrcludex B, 2 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
- Arm B (30 patients): Myrcludex B, 5 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
- Arm C (30 patients): Myrcludex B, 10 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
- Arm D (30 patients): tenofovir treatment for 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Multicenter, Open-label, Randomized
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Myrcludex B, Drug: TenofovirMyrcludex B, 2 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy. |
| Arm B | Experimental | Drug: Myrcludex-B, Drug: TenofovirMyrcludex B, 5 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy. |
| Arm C | Experimental | Drug: Myrcludex-B, Drug: TenofovirMyrcludex B, 10 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy. |
| Arm D | Active comparator | Drug: Tenofovirtenofovir treatment for 48 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age from 18 to 65 years inclusively at the time of signing Informed Consent Form.
- Positive serum HBsAg for at least 6 months before Screening.
- Positive serum anti-HDV antibody for at least 6 months before screening.
- Positive PCR results for serum HDV RNA at Screening.
- Patients with liver cirrhosis, irrespective of previous interferon treatment .
Key exclusion criteria (5 listed)
- Child-Pugh score of B-C or over 6 points.
- HCV or HIV coinfection. Subjects with anti-HCV antibodies can be enrolled, if screening HCV RNA test is negative.
- Creatinine clearance <60 mL/min.
- Total bilirubin ≥ 2mg/dL. Patients with higher total bilirubin values may be included after the consultation with the Study's Medical Monitor, if such elevation can be clearly attributed to Gilbert's syndrome associated with low-grade hyperbilirubinemia.
- Any previous or current malignant neoplasms, including hepatic carcinoma.
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 B2 mg, once daily, subcutaneously | Drug | Arm A |
| Myrcludex-B5 mg, once daily, subcutaneously | Drug | Arm B |
| Myrcludex-B10 mg, once daily, subcutaneously | Drug | Arm C |
| TenofovirAlso: Vireadtenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg | Drug | Arm A, Arm B, Arm C, Arm D |
Primary outcome
HDV RNA Response at Week 24
Time frame: 24 weeks
HDV RNA negativation or decrease by ≥2 log10 from baseline to Week 24
8 secondary outcomes
Durability of HDV RNA Response
Time frame: 48 weeks
Combined Response: HDV RNA Response and Normal ALT at Treatment Week 24
Time frame: 24 weeks
Changes in ALT Values
Time frame: 24 and 48 weeks
Change (Absence of Increase) in Fibrosis Marker
Time frame: 24 and 48 weeks
Change in Hepatitis B Surface Antigen
Time frame: 24 and 48 weeks
Change in HBV DNA Levels at Week 24 and Week 48 Compared to Baseline
Time frame: 24 and 48 weeks
Absence of a Fibrosis Progression According to the Findings of Transient Elastometry
Time frame: 24 weeks
Number of Participants With Improvement of Histological Findings According to the Liver Biopsy Results
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- Derived from this study: PubMed 37120031Hollnberger J, Liu Y, Xu S, Chang S, Martin R, Manhas S, Aeschbacher T, Han B, Yazdi T, May L, Han D, Shornikov A, Flaherty J, Manuilov D, Suri V, Asselah T, Lampertico P, Wedemeyer H, Aleman S, Richards C, Mateo R, Maiorova E, Cihlar T, Mo H, Urban S. No virologic resistance to bulevirtide monotherapy detected in patients through 24 weeks treatment in phase II and III clinical trials for chronic hepatitis delta. J Hepatol. 2023 Sep;79(3):657-665. doi: 10.1016/j.jhep.2023.04.027. Epub 2023 Apr 27.
- Derived from this study: PubMed 36113537Wedemeyer H, Schoneweis K, Bogomolov P, Blank A, Voronkova N, Stepanova T, Sagalova O, Chulanov V, Osipenko M, Morozov V, Geyvandova N, Sleptsova S, Bakulin IG, Khaertynova I, Rusanova M, Pathil A, Merle U, Bremer B, Allweiss L, Lempp FA, Port K, Haag M, Schwab M, Zur Wiesch JS, Cornberg M, Haefeli WE, Dandri M, Alexandrov A, Urban S. Safety and efficacy of bulevirtide in combination with tenofovir disoproxil fumarate in patients with hepatitis B virus and hepatitis D virus coinfection (MYR202): a multicentre, randomised, parallel-group, open-label, phase 2 trial. Lancet Infect Dis. 2023 Jan;23(1):117-129. doi: 10.1016/S1473-3099(22)00318-8. Epub 2022 Sep 13.
- 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.
Heiner Wedemeyer, MD,PhD principal investigator
Dept. of Gastroenterology, Hepatology and Endocrinology Medizinische Hochschule Hannover
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Myrcludex B, Myrcludex-B and Tenofovir in people with Chronic Hepatitis D Infection With Hepatitis B, run by Hepatera Ltd. at 15 sites in 2 countries.
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 16 inclusion and 5 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 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Russia, Germany. 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 30 Dec 2019). 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?
HDV RNA Response at Week 24 (time frame: 24 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 NCT03546621, 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 10 May 2021.