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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-517167-23-00 | EU Trial (CTIS) Number |
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This is a Phase 3, global, randomized, open-label, multicenter, trial evaluating brelovitug (BJT-778) vs bulevirtide for the treatment of chronic hepatitis delta infection (CHD). The main goal of this study is to test the effectiveness of brelovitug compared to bulevirtide as a long-term treatment in patients with chronic HDV infection.
Study consists of 2 arms. Approximately 172 participants will be randomized 3:1 to one of the following treatment arms:
Arm 1: Participants will receive brelovitug 300 mg subcutaneously once weekly for 96 weeks.
Arm 2: Participants will receive bulevirtide 2 mg subcutaneously once daily for 48 weeks, followed by brelovitug 300 mg subcutaneously once weekly for the next 48 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brelovitug | Experimental | Participants will receive treatment with brelovitug 300 mg once weekly for 96 weeks |
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| Bulevirtide for 48 weeks followed by brelovitug for 48 weeks | Active Comparator | Participants will receive bulevirtide 2 mg subcutaneously once daily for 48 weeks, followed by brelovitug 300 mg subcutaneously once weekly for the next 48 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brelovitug 300 mg | Drug | Route of administration- Subcutaneous Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with a composite endpoint of virologic response and ALT normalization | The composite endpoint is defined as virologic response (undetectable HDV RNA, < the lower limit of quantification [LLOQ], target not detected [TND]) and ALT normalization (decrease in ALT from baseline to ≤ upper limit of normal [ULN]) | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with treatment-emergent adverse events (TEAEs) | An AE is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at Screening (e.g., medical history), worsens during the study (post-Baseline/ Day 1), regardless of the suspected cause of the event. | Up to 96 weeks |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note - Other protocol-defined Inclusion/Exclusion criteria apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Clinical Trials Mirum | Contact | +16506674085 | clinicaltrials@mirumpharma.com | |
| Mirum Pharmaceuticals, Inc., Clinical Trials | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz | Recruiting | Graz | 8036 | Austria | ||
| Universitätsklinikum St. Pölten |
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| Bulevirtide 2 mg and Brelovitug - 300 mg | Drug | Route of Administration- Subcutaneous Injection |
|
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| Percentage of participants who discontinue treatment due to an adverse event (AE) |
An AE is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at Screening (e.g., medical history), worsens during the study (post-Baseline/ Day 1), regardless of the suspected cause of the event. |
| Up to 96 weeks |
| Percentage of participants with HDV RNA ≥ 2 log10 IU/mL decline from baseline or TND | Up 96 Weeks |
| Percentage of participants with HDV RNA <LLOQ | Up to 96 Weeks |
| Percentage of participants with HDV RNA <LLOQ, TND | Up to 96 Weeks |
| Percentage of participants with ALT normalization | ALT normalization is defined as a decrease in ALT from baseline to ≤ ULN | Up to 96 Weeks |
| Percentage of participants with ALT normalization in combination with virologic response of HDV RNA ≥ 2 log10 IU/mL decline from baseline or TND | The composite of participants with ALT normalization (decrease in ALT from baseline to ≤ ULN) and virologic response of HDV RNA ≥ 2 log10 IU/mL decline from baseline or TND. | Up to 96 Weeks |
| Percentage of participants with ALT normalization in combination with HDV RNA <LLOQ | The composite of participants with ALT normalization (decrease in ALT from baseline to ≤ ULN) and virologic response of HDV RNA \ | Up to 96 Weeks |
| Percentage of participants with ALT normalization in combination with HDV RNA <LLOQ, TND | The composite of participants with ALT normalization (decrease in ALT from baseline to ≤ ULN) and virologic response of HDV RNA \ | Up to 96 Weeks |
| Change from baseline in liver stiffness as determined by transient elastography (e.g., FibroScan) | Up to 96 Weeks |
| Change from baseline in APRI (AST-to-platelet ratio index) | Up to 96 Weeks |
| Change from baseline in CTP score in participants with cirrhosis | Up to 96 Weeks |
| Change from baseline in Model for End-Stage Liver Disease (MELD) score in participants with cirrhosis | Up to 96 Weeks |
| Percentage of participants with clinical disease progression from baseline in HDV-associated liver disease. | Liver disease progression will be determined by the Independent Data Monitoring Committee (IDMC). | Up to 96 Weeks |
| Percentage of participants with HDV RNA <LLOQ, TND at post-treatment follow up. | Post-Treatment Weeks 24 and 48 |
| Change from baseline in Health-Related Quality of Life (HRQoL) as measured by the Chronic Liver Disease Questionnaire-HBV (CLDQ-HBV) | Up to 96 Weeks |
| Change from baseline in Health-Related Quality of Life (HRQoL) as measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) | Up to 96 Weeks |
| Recruiting |
| Sankt Pölten |
| 3100 |
| Austria |
| Fakultni Nemocnice Brno | Recruiting | Brno | Brno | 62500 | Czechia |
| Fakultni Nemocnice Hradec Kralove | Recruiting | Hradec Králové | Hradec Králové | 500 03 | Czechia |
| Krajská nemocnice Liberec, a.s. | Recruiting | Liberec | Liberec | 460 01 | Czechia |
| Institute For Clinical And Experimental Medicine | Recruiting | Prague | Prague | 140 00 | Czechia |
| Klin Med s.r.o. | Recruiting | Prague | Prague | 2 120 00 | Czechia |
| Hôpital Estaing | Recruiting | Clermont-Ferrand | 63000 | France |
| Hôpital Beaujon | Recruiting | Clichy | 92110 | France |
| University Hospital Henri Mondor - APHP | Recruiting | Créteil | 94000 | France |
| CHU Grenoble Alpes Hopital Nord Michallon | Recruiting | La Tronche | 38700 | France |
| Centre Hospitalier de Versailles _ Hopital Andre Magnot | Recruiting | Le Chesnay | 78157 | France |
| Lille Regional University Hospital Centre | Recruiting | Lille | 59000 | France |
| University Hospital Limoges | Recruiting | Limoges | 87042 | France |
| Hôpital de la Croix-Rousse | Recruiting | Lyon | 69004 | France |
| Hôpital Pitié Salpêtrière | Recruiting | Paris | 75013 | France |
| CHU de Bordeaux - Hopital Haut-Leveque | Recruiting | Pessac | 33604 | France |
| Centre Hospitalier Universitaire De Rennes | Recruiting | Rennes | 35000 | France |
| Hôpital Rangueil | Recruiting | Toulouse | 31059 | France |
| Goethe University Frankfurt | Recruiting | Frankfurt | Frankfurt | 60590 | Germany |
| Rostock University Medical Center | Recruiting | Rostock | Rostock | 18057 | Germany |
| Universitätsklinikum Düsseldorf | Recruiting | Düsseldorf | 40225 | Germany |
| Medizinische Hochschule Hannover | Recruiting | Hanover | 30625 | Germany |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico | Recruiting | Milan | 20122 | Italy |
| AOU Pisana - Cisanello | Recruiting | Pisa | 56126 | Italy |
| National Institute of Infectious Diseases Lazzaro Spallanzani | Recruiting | Roma | 00149 | Italy |
| National Institute Of Infectious Diseases | Recruiting | Bucharest | Bucharest | 021105 | Romania |
| Spitalul Clinic De Boli Infectioase Si Tropicale Dr. Victor Babes | Recruiting | Bucharest | Bucharest | 030303 | Romania |
| Centrul Medical Unirea S.R.L | Recruiting | Iași | Lasi | 700023 | Romania |
| National Institute of Infectious Diseases Prof Dr Matei Bals | Recruiting | Bucharest | 021105 | Romania |
| Spitalul Clinic de Boli Infectioase Constanta | Recruiting | Constanța | 900709 | Romania |
| Hospital Universitario Torrecardenas | Recruiting | Almería | Almeria | 04009 | Spain |
| Hospital Universitari Vall D Hebron | Recruiting | Barcelona | Barcelona | 08035 | Spain |
| Hospital Clinic Provincial De Barcelona | Recruiting | Barcelona | 08036 | Spain |
| Hospital Universitario Ramón y Cajal | Recruiting | Madrid | 28034 | Spain |
| Hospital Universitario Virgen de la Victoria | Recruiting | Málaga | 29010 | Spain |
| Hospital Universitario Marqués de Valdecilla | Recruiting | Santander | 39008 | Spain |
| Hospital Universitario Álvaro Cunqueiro | Recruiting | Vigo | 36312 | Spain |
| Karolinska University Hospital | Recruiting | Huddinge | 14186 | Sweden |
| Hôpitaux Universitaires | Recruiting | Geneva | Canton of Geneva | 1205 | Switzerland |
| HOCH Health Ostschweiz | Recruiting | Sankt Gallen | St.Gallen | 95 9007 | Switzerland |
| Universitätsspital Zürich | Recruiting | Zurich | 8091 | Switzerland |
| Queen Elizabeth Hospital Birmingham | Recruiting | Birmingham | Birmingham | B15 2GW | United Kingdom |
| Chelsea and Westminster Hospital NHS Foundation Trust | Recruiting | London | London | SW10 9NH | United Kingdom |
| North Manchester General Hospital | Recruiting | Manchester | Manchester | M8 5RB | United Kingdom |
| Hull University Teaching Hospitals | Recruiting | Cottingham | HU16 5JQ | United Kingdom |
| Barts Health NHS Trust | Recruiting | London | E12ES | United Kingdom |
| King's College Hospital NHS Foundation Trust | Recruiting | London | SE5 9RS | United Kingdom |
| ID | Term |
|---|---|
| D003699 | Hepatitis D |
| ID | Term |
|---|---|
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000718249 | bulevirtide |
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