Recruiting NCT06980649
Study of BHV-1300 in Graves' Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BHV-1300.
- Who it may be relevant to
- Registry conditions: Graves Disease. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-Label Biomarker Study of BHV-1300 in Graves' Disease
Overview
The purpose of this study is to determine if BHV-1300 is a safe treatment in participants with Graves' Disease and to explore its effect on disease-specific biomarkers.
Interventions
- Drug BHV-1300
BHV-1300 is delivered subcutaneously (SC)
Primary outcome measures
- Number of participants with Serious AEs (SAEs), AEs leading to discontinuation, deaths [Time frame: Baseline to Week 52]
- Number of participants with Grade 3-4 (CTCAE/DAIDS) treatment-emergent laboratory abnormalities [Time frame: Baseline to Week 52]
Eligibility criteria
Inclusion criteria
1\. Participants must have serologically confirmed Graves' Disease.
Exclusion criteria
- 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.
- History of treatment with radioactive iodine or thyroid surgery.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 10 centers
- Site-103 — South Gate
- Site-100 — Miami
- Site-104 — Columbus
- Site-108 — Greenville
- Site-110 — Canton
- Site-107 — Memphis
- Site-109 — Dallas
- Site-106 — Houston
- … and 2 more centers
Australia · 8 centers
- Site-004 — Fitzroy
- Site-011 — Herston
- Site-001 — Kotara
- Site-003 — Melbourne
- Site-010 — Oaklands Park
- Site-008 — Parkville
- Site-006 — St Leonards
- Site-002 — Torquay
Identifiers
NCT: NCT06980649 · BHV1300-202