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Clinical Trials in Israel / NCT06907290
Active, not recruiting Phase 2/3

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

NCT06907290 · tracked via the Priya Life Science Israel tracker
Sponsor
Mirum Pharmaceuticals, Inc
Phase
Phase 2/3
Started
2025-03-25
Last updated
2026-03-02

Condition(s) studied

Chronic Hepatitis D Infection

Investigational drug(s) / intervention(s)

Brelovitug 300 mg →Brelovitug 900 mg →Delayed Treatment with Brelovitug 300mg

Brelovitug 300 mg: Route of administration- Subcutaneous Injection

Brelovitug 900 mg: Route of administration- Subcutaneous Injection

Delayed Treatment with Brelovitug 300mg: Route of administration- Subcutaneous Injection

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (38)

FacilityCityRegionStatus
247 Garden Grove Garden Grove California
242 Huntington Beach Huntington Beach California
252 Long Beach Long Beach California
244 Los Angeles Los Angeles California
250 Miami Miami Florida
251, Illinois Chicago Illinois
248 Lowa Cities in Iowa Iowa
254 Baltimore Baltimore Maryland
241, Massachusetts Boston Massachusetts
245 New York New York New York
256 New York New York New York
253 New York New York New York
255 New York New York New York
257 Philadelphia Philadelphia Pennsylvania
249 San Antonio San Antonio Texas
102 Melbourne Melbourne Victoria
101 Camperdown Camperdown Australia
104 Liverpool Liverpool Australia
703 Sliven Sliven Silven
705 Plovdiv Plovdiv Bulgaria
702 Bulgaria Sofia Bulgaria
706 Sofia Sofia Bulgaria
704 Stara Zagora Stara Zagora Bulgaria
233 Calgary Calgary Calgary
234 Alberta Edmonton Edmonton
231 Toronto Toronto Ontario
235 Montreal Montreal Quebec
181 Tbilisi Tbilisi Georgia
183 Tbilisi Tbilisi Georgia
182 Tbilisi Tbilisi Georgia
212 Haifa Haifa Haifa District
211 Israel Beersheba Israel
901 Chisinau Chisinau Moldova
001 Auckland Auckland New Zealand
221 Karachi City Karachi Karachi
291 Belgrade Belgrade Belgrade
191 Istanbul Istanbul Istanbul
110 Kyiv Kyiv Ukraine

More Mirum Pharmaceuticals, Inc. trials in Israel

A Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4) Active, not recruiting
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis Active, not recruiting
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC) Active, not recruiting

Other trials for the same condition

A Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06907290 on ClinicalTrials.gov ↗ ← All trials in Israel