At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Brelovitug (BJT-778) (drug), Bulevirtide (drug)
- How long the study runs
- Study runs about 37 months (dates as stated)
- About the drug or intervention
- Brelovitug (BJT-778) — drug: Brelovitug (BJT-778), 300 mg administered subcutaneously once weekly for 96 weeks. · Bulevirtide — drug: Bulevirtide - once daily.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 120
- Started
- 2026-02-26
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for chronic hepatitis d
- • Phase2/Phase3 - 120 participants
- • 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)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with chronic hepatitis d
Where?
- • Cottingham - Castle Hill Hospital
- • Cardiff - Cardiff and Vale University Health Board
- • London - Barts Health NHS Trust
- • London - King's College Hospital NHS Foundation Trust
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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).
More detail
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).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Willing and able to provide written agreement to take part.
- ✓Male or female, ≥18 years of age at Screening.
- ✓Taking or willing to take TDF, TAF, or ETV at baseline, and willing to remain on stable treatment for the duration...
- ✓Currently taking bulevirtide treatment for CHD for ≥6 months at the time of Screening.
- ✓HDV RNA ≥100 IU/mL at Screening.
Who cannot take part
- ✗Evidence of decompensated liver disease (e.g., CTP Class B or C, history of liver encephalopathy, clinically...
- ✗Known history of immune-complex disease.
- ✗Active or clinically significant co-infection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
- ✗Evidence of other significant liver diseases (e.g., autoimmune hepatitis, primary biliary cholangitis, primary...
- ✗History of hepatocellular carcinoma (HCC) or evidence of HCC on screening imaging.
See the full criteria
Where Is This Study? (6 UK sites)
Castle Hill Hospital
Cottingham HU165JQ, United Kingdom
James Illingworth
hyp-tr.development.research@nhs.net01482 461883 or 461903Cardiff and Vale University Health Board
Cardiff CF14 4XW, United Kingdom
Barts Health NHS Trust
London E12AT, United Kingdom
King's College Hospital NHS Foundation Trust
London SE5 9RS, United Kingdom
Chelsea and Westminster Hospital
London SW109NH, United Kingdom
Manchester University Nhs Foundation Trust
Manchester M13 9WL, United Kingdom
How to Get in Touch
Clinical Trials Mirum
Sponsor contactCONTACT
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