A Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection

Running, not enrolling · Phase 2/Phase 3

Conditions studied: Chronic Hepatitis D Infection

In brief

This is a Phase 2b/3 study designed to evaluate the safety and efficacy of chronic treatment with brelovitug (a.k.a BJT-778; BTG) for chronic hepatitis delta virus (HDV) infection. The comparator in this study will be 24-weeks of delayed treatment. During the 24-weeks of delayed treatment, participants will complete the same visits and assessments as those randomized to initiate brelovitug immediately. At the completion of 24-week delayed treatment period, all participants will start treatment with brelovitug.

Key facts

Study ID

NCT06907290

Run by

Mirum Pharmaceuticals, Inc.

People needed

150

Starts

2025-03-25

Expected to finish

2029-09-01

Last updated by the study team

2026-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Willing and able to provide written informed consent.
• Chronic HDV infection
• HDV RNA >500 IU/mL at Screening.
• Abnormal ALT (>upper limit of normal) at Screening.
• Willing to take or already taking HBV nucleos(t)ide therapy

You may not qualify if…

• Pregnant or nursing females.
• Unwilling to comply with contraception requirements during the study.
• Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
• Presence of other liver disease(s) (does not include HBV or HDV infection) such as non-alcoholic steatohepatitis (NASH), alcohol associated hepatitis, cholestatic liver disease, hepatocellular carcinoma.
• Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage).
• Solid organ or bone marrow transplantation Note: other protocol defined Inclusion/Exclusion criteria may apply.

Where it is running

• 247 Garden Grove — Garden Grove, California, United States
• 242 Huntington Beach — Huntington Beach, California, United States
• 252 Long Beach — Long Beach, California, United States
• 244 Los Angeles — Los Angeles, California, United States
• 250 Miami — Miami, Florida, United States
• 251, Illinois — Chicago, Illinois, United States
• 248 Lowa — Cities in Iowa, Iowa, United States
• 254 Baltimore — Baltimore, Maryland, United States
• 241, Massachusetts — Boston, Massachusetts, United States
• 245 New York — New York, New York, United States
• 256 New York — New York, New York, United States
• 253 New York — New York, New York, United States
• 255 New York — New York, New York, United States
• 257 Philadelphia — Philadelphia, Pennsylvania, United States
• 249 San Antonio — San Antonio, Texas, United States
• 102 Melbourne — Melbourne, Victoria, Australia
• 101 Camperdown — Camperdown, Australia
• 104 Liverpool — Liverpool, Australia
• 703 Sliven — Sliven, Silven, Bulgaria
• 705 Plovdiv — Plovdiv, Bulgaria
• 702 Bulgaria — Sofia, Bulgaria
• 706 Sofia — Sofia, Bulgaria
• 704 Stara Zagora — Stara Zagora, Bulgaria
• 233 Calgary — Calgary, Calgary, Canada
• 234 Alberta — Edmonton, Edmonton, Canada

Full record on ClinicalTrials.gov

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