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Looking for participantsPhase2/Phase3

Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide

Sponsor: Mirum Pharmaceuticals, Inc.

NCT ID: NCT07454837

View on ClinicalTrials.gov ↗

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).

Chronic Hepatitis D

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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
Inclusion Criteria: 1. Willing and able to provide written informed consent. 2. Male or female, ≥18 years of age at Screening. 3. Taking or willing to take TDF, TAF, or ETV at baseline, and willing to remain on stable treatment for the duration of the study. 4. Currently taking bulevirtide treatment for CHD for ≥6 months at the time of Screening. 5. HDV RNA ≥100 IU/mL at Screening. Exclusion Criteria: 1. Evidence of decompensated liver disease (e.g., CTP Class B or C, history of hepatic encephalopathy, clinically significant ascites, or variceal bleeding). 2. Known history of immune-complex disease. 3. Active or clinically significant co-infection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV). 4. Evidence of other significant liver diseases (e.g., autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis). 5. History of hepatocellular carcinoma (HCC) or evidence of HCC on screening imaging.

Where Is This Study? (6 UK sites)

Castle Hill Hospital

Cottingham HU165JQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

James Illingworth

hyp-tr.development.research@nhs.net01482 461883 or 461903

Cardiff and Vale University Health Board

Cardiff CF14 4XW, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Martin

research.development@wales.nhs.uk029 2074 6986

Barts Health NHS Trust

London E12AT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mays Jawad

research.governance@qmul.ac.uk020 7882 6826

King's College Hospital NHS Foundation Trust

London SE5 9RS, United Kingdom

Recruiting
Hospital R&D contact (matched)

Jasmine Palmer

kch-tr.research@nhs.net0203 299 1980

Chelsea and Westminster Hospital

London SW109NH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Damon Foster

damon.foster2@nhs.net020 3316 6887

Manchester University Nhs Foundation Trust

Manchester M13 9WL, United Kingdom

Recruiting
Hospital R&D contact (matched)

Elizabeth Mainwaring

R&D.applications@mft.nhs.uk0161 276 3340

How to Get in Touch

Clinical Trials Mirum

Sponsor contact

CONTACT

+16506674085 clinicaltrials@mirumpharma.com

Medinfo Mirum

Sponsor contact

CONTACT

medinfo@mirumpharma.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09