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A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled Study of RVT-1401 for the Treatment of Patients with Active, Moderate to Severe Graves’ Ophthalmopathy
Rochester, Minn.
The purpose of this study is to examine the effects of RVT-1401 versus placebo on proptosis responder rate at week 7, and to assess the safety and tolerability of RVT-1401 in patients with active, moderate to severe Graves' Ophthalmopathy (GO).
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A Phase 2b, Randomized, Double-Mask, Placebo-Controlled, Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Linsitinib in Subjects with Active, Moderate to Severe Thyroid Eye Disease (TED) (VGN-TED-301)
Rochester, Minn.
The purpose of this study is to evaluate the safety and tolerability of linsitinib. Study drug is administered twice daily for six-months (24 weeks) in approximately 75 men and women (25 of which will be randomized to placebo) with active, moderate-to-severe Thyroid Eye Disease (TED).
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A Phase 3b/4, Double-masked, Randomized, International, Parallel-assignment, Multicenter Trial in Patients with Thyroid Eye Disease to Evaluate the Safety and Tolerability of Different Dosing Durations of Teprotumumab (HZNP-TEP-402)
Rochester, Minn.
The purpose of this study is to evaluate the safety, effectiveness and need for re-treatment of 3 different teprotumumab treatment durations for thyroid eye disease (TED). In addition, serum samples from patients with a Baseline Clinical Activity Score (CAS) ≥ 3 will be evaluated for biomarkers of disease.
Teprotumumab was approved by the United States Food and Drug Administration on 21 January 2020 for the treatment of TED under the name TEPEZZA® (teprotumumab-trbw).
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A Phase 4, Randomized, Double-masked, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of TEPEZZA® in Treating Patients with Chronic (Inactive) Thyroid Eye Disease (HZNP-TEP-403)
Rochester, Minn.
The primary purpose of this study is to investigate the effectiveness, safety and tolerability of TEPEZZA® (teprotumumab-trbw) in comparison to placebo in treating patients with chronic (inactive) TED.
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An Open Label Study to Evaluate the Safety and Efficacy of 12 Week Treatment with CFZ533 in Patients with Graves' Disease
Rochester, Minn.
The purpose of this study is to evaluate the safety and effectiveness of CFZ533 following 12 weeks of treatment in patients with Graves' disease.
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Characterization of Thyroid Hormones in Patients Undergoing Radiofrequency Ablation for Thyroid Nodules (RFA-BD)
Rochester, Minn.
The purpose of this pilot study is to evaluate the effects of Radiofrequency Ablation (RFA) on thyroid hormones to treat thyroide nodules.
Radiofrequency ablation (RFA) of thyroid nodules would locally destroy follicular thyroid cells and could possibly impart conformational changes to the chemistry of thyroid hormones, thus altering their bioactive profiles. To evaluate this phenomenon, in vitro investigations to characterize qualitative and quantitve Mass Spectrometric chromatographic profile for thyroid hormones will be performed before and after RFA from patients undergoing ablation for thyroid nodules. {If there is a blood draw for clinical tests, we would request left over specimen from clinical laboratory for research purpose and consider this pre RFA draw; only if otherwise we would have a research preRFA blood draw; for post RFA we would have exclusive research blood draw}.
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Evaluation of New Thyroid Stimulating Immunoglobulin (TSI) Assay (MVSS Study OTP001-17 ENDO)
Rochester, Minn.
This study is being done to see if better therapies can be developed to treat Graves’ disease, using new laboratory assays
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Pilot Study for the Treatment of Papillary Thyroid Carcinoma With Radiofrequency Ablation
Rochester, Minn.
The purpose of this study is to evaluate the efficiency of Radiofrequency ablation (RFA) therapy to treat papillary thyroid carcinoma.
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Pilot Study for Treatment of Amiodarone-Induced Thyroiditis with Radiofrequency Ablation
Rochester, Minn.
The purpose of this study is to analyze the changes in serum thyroid hormone levels in amiodone-induced thyroiditis (AIT) patients after radiofrequency ablation (RFA) therapy on a portion of thyroid parenchyma in order to safely decrease thyroid hormone levels into the normal range with resolution of thyrotoxicosis.
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Pilot Study of Teriparatide for Postsurgical Hypoparathyroidism
Rochester, Minn.
Will teriparatide ( Forteo) shorten the length of hospitalization post thyroidectomy in patients with symptomatic hypoparathyroidism
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Placental Deiodinase Activity in Thyroid Hormone Resistance
Rochester, Minn.
The purpose of this study is to determine the placental D3 activity in a woman with RTH and compare to women without RTH because we believe this may be a potential mechanism which limits fetal thyroid hormone exposure.
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Prevention of Overt Hypothyroidism Following Radioactive Iodine Therapy for Graves' Disease
Rochester, Minn.
The study will try to answer the question of whether early treatment with levothyroxine at 4 weeks after radioactive iodine for Graves' disease will prevent overt hypothyroidism (low thyroid hormone levels).
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Thyroid Autoimmunity Biobank
Rochester, Minn.
We plan to create a databank of serum and tissue samples from patients with thyroid autoimmunity, mainly focusing on Graves’ disease and Graves’ orbitopathy, respectively. This set of samples will allow us to study these disorders better in the laboratory as well as test potential agents that can be used as therapies.
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