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โ† Trials
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Study to Determine if BHV-1300 is Effective and Safe in Adults With Graves' Disease

RecruitingPhase 3Ages 18 Years - 70 YearsAllBiohaven Therapeutics Ltd.
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to evaluate the efficacy and safety of BHV-1300 in adult participants with Graves' disease who are actively hyperthyroid

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Key Inclusion Criteria: 1. Participants must have serologically confirmed Graves' disease as documented by presence of elevated autoantibodies 2. Participants must have active hyperthyroidism due to Graves' disease Key Exclusion Criteria: 1. History of hyperthyroidism not caused by Graves' Disease (e.g., toxic adenoma or toxic multinodular goiter) 2. History of treatment with radioactive iodine or thyroid surgery. 3. Have received levothyroxine, desiccated thyroid extract, or T3 at any dose within six weeks of the Baseline/Day 1 Visit. 4. Thyroid storm, i.e. severe thyrotoxicosis with evidence of systemic decompensation (e.g., Burch-Wartkofsky Point Scale of โ‰ฅ 45 or Japanese Thyroid Association category 1 or 2, with accompanying manifestations including hyperpyrexia, tachycardia, arrhythmias, congestive heart failure, agitation, delirium, psychosis, stupor, and coma, as well as nausea, vomiting, diarrhea, or hepatic failure) within 6 weeks of Screening. 5. Have autoimmune disease other than Graves' disease requiring treatment 6. Have moderate to severe thyroid eye disease (TED) or are expected to require immediate surgical intervention and/or are planning corrective surgery/irradiation or medical therapy for TED during study participation. 7. Are expected to require urgent or emergent thyroid surgery or ablation within six weeks of Baseline/Day 1 or throughout the study.
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What it tests

  • BHV-1300
  • Placebo
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Where

56 sites
Site-044
Tucson, United States
Site-032
Burbank, United States
Site-062
Huntington Beach, United States
Site-048
Oakland, United States
Site-006
San Diego, United States
Site-078
South Gate, United States
Site-067
Walnut Creek, United States
Site-035
Washington D.C., United States

โ€ฆand 48 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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