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A Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection
Sponsor: Mirum Pharmaceuticals, Inc.
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.
Official title: A Global, Randomized, Open-label, Multicenter, Phase 2b/3 Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-1)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2025-03-25
Completion Date
2029-09
Last Updated
2026-03-02
Healthy Volunteers
No
Conditions
Interventions
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
Locations (38)
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
231 Toronto
Toronto, Ontario, Canada
235 Montreal
Montreal, Quebec, Canada
181 Tbilisi
Tbilisi, Georgia
183 Tbilisi
Tbilisi, Georgia
182 Tbilisi
Tbilisi, Georgia
212 Haifa
Haifa, Haifa District, Israel
211 Israel
Beersheba, Israel
901 Chisinau
Chisinau, Moldova
001 Auckland
Auckland, New Zealand
221 Karachi City
Karachi, Karachi, Pakistan
291 Belgrade
Belgrade, Belgrade, Serbia
191 Istanbul
Istanbul, Istanbul, Turkey (Türkiye)
110 Kyiv
Kyiv, Ukraine