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Active (not recruiting) Phase 2/3 NCT06907290

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

Phase 2/3 – combined trial
Conditions: Chronic Hepatitis D Infection

Sponsor: Mirum Pharmaceuticals, Inc.

trial.available_in: БГ
Overview
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.
Description
Study will consist of 3 study arms. Approximately 150 participants will be randomized 2:2:1 to one of the following treatment arms: * Arm 1: Participants randomized to Arm 1 will receive brelovitug 300 mg subcutaneously once weekly. * Arm 2: Participants randomized to Arm 2 will receive brelovitug 900 mg subcutaneously once every 4 weeks. * Arm 3: Participants randomized to Arm 3 will attend study clinic visits and delay treatment with brelovitug. At Week 24, all participants will receive brelovitug 300 mg subcutaneously once weekly.
Who can participate
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.
Locations 12
Australia (1)
102 Melbourne
Melbourne , Victoria
Bulgaria (1)
703 Sliven
Sliven , Silven
Canada (1)
233 Calgary
Calgary , Calgary
Georgia (1)
181 Tbilisi
Tbilisi
Israel (1)
212 Haifa
Haifa , Haifa District
Moldova (1)
901 Chisinau
Chisinau
New Zealand (1)
001 Auckland
Auckland
Pakistan (1)
221 Karachi City
Karachi , Karachi
Serbia (1)
291 Belgrade
Belgrade , Belgrade
Turkey (1)
191 Istanbul
Istanbul , Istanbul
Ukraine (1)
110 Kyiv
Kyiv
United States (1)
247 Garden Grove
Garden Grove , California
Technical details
Status
Active (not recruiting)
Phase
Phase 2/3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
25.03.2025
Completion date
01.09.2029
Registry ID
NCT06907290
Source
anzctr
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