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This is a Phase 2b/3, randomized, open-label, multicenter trial evaluating the efficacy and safety of switching from bulevirtide to brelovitug for the treatment of chronic hepatitis Delta infection (CHD).
This is a Phase 2b/3, open-label, multicenter study evaluating the efficacy and safety of switching participants on bulevirtide to brelovitug for the treatment of chronic hepatitis delta (CHD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Switch to Brelovitug | Experimental | Participants will switch to brelovitug 300 mg once weekly for 96 weeks. |
|
| Delayed Switch from Bulevirtide to Brelovitug | Experimental | Participants will continue bulevirtide once daily and then switch to brelovitug 300 mg once weekly for 72 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brelovitug (BJT-778) | Drug | Brelovitug (BJT-778), 300 mg administered subcutaneously once weekly for 96 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with undetectable HDV RNA (<LLOQ Target not detected [TND]) | The proportion of participants with undetectable HDV RNA (\ | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of treatment-emergent adverse events (TEAEs) | Incidence and severity of treatment-emergent adverse events (TEAEs) during brelovitug and bulevirtide treatment periods. | Up to Week 96 |
| Proportion of participants who permanently discontinue treatment due to an adverse event |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Mirum | Contact | +16506674085 | clinicaltrials@mirumpharma.com | |
| Medinfo Mirum | Contact | medinfo@mirumpharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz | Recruiting | Graz | 8010 | Austria | ||
| Medizinische Universitat Innsbruck |
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| Bulevirtide | Drug | Bulevirtide - once daily. Brelovitug (BJT-778) - 300 mg once weekly for 72 weeks following bulevirtide. |
|
|
Proportion of participants who permanently discontinue study treatment because of an adverse event. |
| Up to Week 96 |
| Change from baseline in serum total bile salts | Mean change from baseline in serum total bile salt levels. | Up to Week 96 |
| Proportion of participants achieving virologic response (HDV RNA ≥2 log10 IU/mL decline from baseline or HDV RNA <LLOQ, TND) | Proportion of participants with virologic response at Weeks 24, 48, 72, and 96. | Up to Week 96 |
| Proportion of participants achieving HDV RNA < LLOQ at Weeks 24, 48, 72 and 96. | Up to Week 96 |
| Proportion of participants achieving undetectable HDV RNA (HDV RNA < LLOQ, TND) at Weeks 48, 72, and 96. | Up to Week 96 |
| Proportion of participants achieving normal ALT at Weeks 24, 48, 72 and 96. | Up to Week 96 |
| Proportion of participants achieving normal ALT with virologic response (HDV RNA ≥2 log10 IU/mL decline from baseline or HDV RNA <LLOQ, TND) | Proportion of participants with normal ALT and virologic response at Weeks 24, 48, 72, and 96. | Up to Week 96 |
| Proportion of participants achieving normal ALT with HDV RDA < LLOQ at Weeks 24, 48, 72 and 96. | Up to Week 96 |
| 11. Proportion of participants achieving normal ALT with undetectable HDV RNA (HDV RNA < LLOQ, TND) at Weeks 24, 48, 72 and 96 | Up to Week 96 |
| Change from baseline in HDV RNA | Change from baseline in HDV RNA levels over time during treatment. | Up to Week 96 |
| Change from baseline in ALT levels | Change from baseline ALT levels over time during treatment. | Up to Week 96 |
| Change from baseline in liver stiffness | Change from baseline in liver stiffness as determined by transient elastography at weeks 24, 48 and 96 | Up to Week 96 |
| Change from baseline in APRI | Change from baseline in APRI at weeks 24, 48 and 96. | Up to Week 96 |
| Change from baseline in CTP score | Change from baseline in CTP score at Weeks 24, 48, and 96 in participants with cirrhosis | Up to Week 96 |
| Change from baseline in MELD score | Change from baseline in MELD score at Weeks 24, 48, and 96 in participants with cirrhosis | Up to Week 96 |
| Proportion of participants with clinical disease progression from baseline | Proportion of participants with clinical disease progression from baseline in HDV-associated liver disease at Weeks 24, 48, and 96. | Up to Week 96 |
| Proportion of participants who achieve HDV RNA < LLOQ, TND at post-treatment follow-up | Up to Week 48 |
| Recruiting |
| Innsbruck |
| A-6020 |
| Austria |
| Fakultni Nemocnice Brno (University Hospital Brno) | Recruiting | Brno | 62500 | Czechia |
| Klin Med Ltd. (KLIN MED s.r.o.) | Recruiting | Prague | 12000 | Czechia |
| Institut klinicke a experimentalni mediciny- IKEM (Institute for Clinical and Experimental Medicine) | Recruiting | Prague | 14021 | Czechia |
| CHU de Bordeaux | Recruiting | Bordeaux | 33076 | France |
| Clermont-Ferrand University Hospital | Recruiting | Clermont-Ferrand | 63100 | France |
| Hospital Beaujon | Recruiting | Clichy | 92110 | France |
| Henri Mondor University Hospital (APHP) | Recruiting | Créteil | 94000 | France |
| CHU Grenoble Alpes Hopital Nord Michallon | Recruiting | Grenoble | 38700 | France |
| CHU Limoges | Recruiting | Limoges | 87000 | France |
| Hospital De La Croix Rousse | Recruiting | Lyon | 69004 | France |
| Hopital Saint-Eloi | Recruiting | Montpellier | 34090 | France |
| Pitie-Salpetriere Hosptial | Recruiting | Paris | 75013 | France |
| CHU Toulouse Hospital Rangueil, Toulouse | Recruiting | Toulouse | 31400 | France |
| University Hospital of Dusseldorf | Recruiting | Düsseldorf | 40225 | Germany |
| Goethe University Frankfurt | Recruiting | Frankfurt | 60323 | Germany |
| Medizinische Hochschule Hannover | Recruiting | Hanover | 30625 | Germany |
| Universitatsmedizin Rostock | Recruiting | Rostock | 18057 | Germany |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Recruiting | Milan | 20122 | Italy |
| Centrul Medical Unirea S.R.L | Recruiting | Iași | Lasi | 700023 | Romania |
| National Institute Of Infectious Diseases Prof. Dr. Matei Bals | Recruiting | Bucharest | 021105 | Romania |
| Fundeni Clinical Institute | Recruiting | Bucharest | 022328 | Romania |
| Clinical Hospital for Infectious and Tropical Diseases Dr. Victor Babes | Recruiting | Bucharest | 030303 | Romania |
| National Institute Of Infectious Diseases Prof. Dr. Matei Bals | Recruiting | Bucharest | 21105 | Romania |
| Spitalul Clinic de Boli Infectioase Constanta | Recruiting | Constanța | 900709 | Romania |
| Vall d'Hebron Hospital | Recruiting | Barcelona | 08035 | Spain |
| Hospital Clinic I Provincial De Barcelona | Recruiting | Barcelona | 08036 | Spain |
| Hospital Universitario Ramon y Cajal | Recruiting | Madrid | 28034 | Spain |
| Castle Hill Hospital | Recruiting | Cottingham | Yorkshire | HU165JQ | United Kingdom |
| Cardiff and Vale University Health Board | Recruiting | Cardiff | CF14 4XW | United Kingdom |
| Barts Health NHS Trust | Recruiting | London | E12AT | United Kingdom |
| King's College Hospital NHS Foundation Trust | Recruiting | London | SE5 9RS | United Kingdom |
| Chelsea and Westminster Hospital | Recruiting | London | SW109NH | United Kingdom |
| Manchester University Nhs Foundation Trust | Recruiting | Manchester | M13 9WL | United Kingdom |
| ID | Term |
|---|---|
| D019701 | Hepatitis D, Chronic |
| ID | Term |
|---|---|
| D003699 | Hepatitis D |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000718249 | bulevirtide |
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