Overview Study details Eligibility Things to know Research Study plan

Simplify with AI

Overview Study details Eligibility Things to know Research Study plan

Simplify with AI

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

PHASE2PHASE3ACTIVE_NOT_RECRUITING

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.

Study details:

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.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

Study type

TREATMENT

Phase

PHASE2PHASE3

Study ID

NCT06907290

Intervention or treatment

DRUG: Brelovitug 300 mg

DRUG: Brelovitug 900 mg

DRUG: Delayed Treatment with Brelovitug 300mg

Conditions

Chronic Hepatitis D Infection

Condition: Chronic Hepatitis D Infection
DRUG: Brelovitug 300 mg and other drugs
Camperdown, Australia and more
Sponsor: Bluejay Therapeutics, Inc.

Save

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

101 Camperdown

Select from list below to view details:

101 Camperdown
Camperdown, Australia
104 Liverpool
Liverpool, Australia

Loading map...

Who is running the clinical trial?

BTI

Bluejay Therapeutics, Inc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Brelovitug 300mg Dose - brelovitug 300 mg Frequency- once weekly	Drug: Brelovitug 300 mg
EXPERIMENTAL: Brelovitug 900mg Dose - brelovitug 900 mg Frequency- once every 4 weeks	Drug: Brelovitug 900 mg
ACTIVE_COMPARATOR: Delayed Treatment with brelovitug 300mg Dose - brelovitug 300 mg Frequency- 24 weeks of delayed treatment, then once weekly	Drug: Delayed Treatment with Brelovitug 300mg

What is the study measuring?

Primary Outcome

Measure	Description	Time Frame
Percentage of participants with a composite endpoint	Achieving composite endpoint defined as virologic response (undetectable HDV RNA or decline in HDV RNA ≥2 log10 IU/mL) and ALT normalization	Week 24

Secondary Outcome

Measure	Description	Time Frame
Percentage of participants with treatment-emergent adverse events (TEAE) as assessed by DAIDS	Frequency and severity of TEAEs and serious AEs	Weeks 24, 48, 96, and 120, if applicable
Percentage of participants that achieve that achieve virologic response and ALT normalization	Change from baseline in HDV RNA and ALT normalization	Weeks 24, 48, 96, and 120, if applicable
Percentage of participants with a composite endpoint by treatment regimen	Compare the composite endpoint response (change from baseline HDV RNA and ALT normalization) between weekly versus every 4-week regimen of brelovitug	Weeks 24, 48, 96, and 120, if applicable
Percentage of participants with HDV associated liver disease progression	Determined by an independent data monitoring committee based on changes in liver stiffness, APRI, CPT/MELD score (cirrhotic), and TEAEs.	Weeks 24, 48, 96, and 120, if applicable

Are you running this trial?If you're a clinic or sponsor, you can claim this study.

Claim this trial

References

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

Other trials to consider

Loading suggested trials...