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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BHV-1300 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BHV-1300 | Drug | BHV-1300 is delivered subcutaneously (SC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Serious AEs (SAEs), AEs leading to discontinuation, deaths | To assess the safety and tolerability of BHV-1300. This objective will be measured by assessing the number of unique subjects with SAEs, AEs leading to discontinuation or deaths that are observed during the Open-label Treatment Phase (up to 52 weeks). | Baseline to Week 52 |
| Number of participants with Grade 3-4 (CTCAE/DAIDS) treatment-emergent laboratory abnormalities | To assess the safety and tolerability of BHV-1300. This objective will be measured by assessing the number of unique subjects with Grade 3 or 4 treatment-emergent laboratory abnormalities. | Baseline to Week 52 |
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Key Inclusion Criteria:
1. Participants must have serologically confirmed Graves' Disease.
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Contact | 203-404-0410 | clinicaltrials@biohavenpharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site-103 | Recruiting | South Gate | California | 90280 | United States | |
| Site-100 |
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| ID | Term |
|---|---|
| D006111 | Graves Disease |
| D006980 | Hyperthyroidism |
| D013959 | Thyroid Diseases |
| D001327 | Autoimmune Diseases |
| D004700 | Endocrine System Diseases |
| ID | Term |
|---|---|
| D005094 | Exophthalmos |
| D009916 | Orbital Diseases |
| D005128 | Eye Diseases |
| D006042 | Goiter |
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| Recruiting |
| Miami |
| Florida |
| 33126 |
| United States |
| Site-104 | Recruiting | Columbus | Georgia | 31904 | United States |
| Site-108 | Recruiting | Greenville | North Carolina | 27834 | United States |
| Site-110 | Recruiting | Canton | Ohio | 44718 | United States |
| Site-107 | Recruiting | Memphis | Tennessee | 38119 | United States |
| Site-109 | Recruiting | Dallas | Texas | 75246 | United States |
| Site-106 | Recruiting | Houston | Texas | 77054 | United States |
| Site-101 | Recruiting | Houston | Texas | 77095 | United States |
| Site-105 | Recruiting | Shavano Park | Texas | 78231 | United States |
| Site-004 | Recruiting | Fitzroy | 3065 | Australia |
| Site-001 | Recruiting | Kotara | 2289 | Australia |
| Site-003 | Recruiting | Melbourne | 3128 | Australia |
| Site-010 | Recruiting | Oaklands Park | 5046 | Australia |
| Site-008 | Recruiting | Parkville | 3050 | Australia |
| Site-006 | Recruiting | St Leonards | 2065 | Australia |
| Site-002 | Recruiting | Torquay | 3228 | Australia |
| D007154 |
| Immune System Diseases |