Trial Review

Please note that the ANZCTR will be unattended on Monday 9th June due to an Australian public holiday.

Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06980649




Registration number
NCT06980649
Ethics application status
Date submitted
12/05/2025
Date registered
20/05/2025
Date last updated
28/05/2025

Titles & IDs
Public title
Study of BHV-1300 in Graves' Disease
Scientific title
An Open-Label Biomarker Study of BHV-1300 in Graves' Disease
Secondary ID [1] 0 0
BHV1300-202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Graves Disease 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BHV-1300

Experimental: BHV-1300 -


Treatment: Drugs: BHV-1300
BHV-1300 is delivered subcutaneously (SC)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants with normalization of T3 and T4
Timepoint [1] 0 0
Baseline to Week 12
Secondary outcome [1] 0 0
Number of participants with Serious AEs (SAEs), AEs leading to discontinuation, deaths
Timepoint [1] 0 0
Baseline to Week 12
Secondary outcome [2] 0 0
Number of participants with Grade 3-4 (CTCAE/DAIDS) treatment-emergent laboratory abnormalities.
Timepoint [2] 0 0
Baseline to Week 12

Eligibility
Key inclusion criteria
Key

1. Participants must have serologically confirmed Graves' Disease.
2. Participants must have active hyperthyroidism due to Graves' Disease.

Key
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of hyperthyroidism not caused by Graves' Disease (e.g., toxic adenoma or toxic multinodular goiter) and/or history of thyroid storm within six weeks of the Baseline visit.
2. History of treatment with radioactive iodine or thyroid surgery.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2026
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Site-001 - Kotara
Recruitment postcode(s) [1] 0 0
2289 - Kotara

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biohaven Therapeutics Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Chief Medical Officer
Address 0 0
Country 0 0
Phone 0 0
203-404-0410
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06980649