Chronic Hepatitis D Infection
Conditions
Keywords
Hepatitis Delta virus, HDV, Hepatitis D infection, Hepatitis D virus
Brief 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.
Detailed 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.
Interventions
Route of administration- Subcutaneous Injection
Route of administration- Subcutaneous Injection
Route of administration- Subcutaneous Injection
Sponsors
Mirum Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with a composite endpoint | Week 24 | Achieving composite endpoint defined as virologic response (undetectable HDV RNA or decline in HDV RNA ≥2 log10 IU/mL) and ALT normalization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with treatment-emergent adverse events (TEAE) as assessed by DAIDS | Weeks 24, 48, 96, and 120, if applicable | Frequency and severity of TEAEs and serious AEs |
| Percentage of participants that achieve that achieve virologic response and ALT normalization | Weeks 24, 48, 96, and 120, if applicable | Change from baseline in HDV RNA and ALT normalization |
| Percentage of participants with a composite endpoint by treatment regimen | Weeks 24, 48, 96, and 120, if applicable | Compare the composite endpoint response (change from baseline HDV RNA and ALT normalization) between weekly versus every 4-week regimen of brelovitug |
| Percentage of participants with HDV associated liver disease progression | Weeks 24, 48, 96, and 120, if applicable | Determined by an independent data monitoring committee based on changes in liver stiffness, APRI, CPT/MELD score (cirrhotic), and TEAEs. |
Countries
Australia, Bulgaria, Canada, Georgia, Israel, Moldova, New Zealand, Pakistan, Serbia, Turkey (Türkiye), Ukraine, United States
Outcome results
None listed