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Graves Disease clinical trials

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NCT ID: NCT03066076 Recruiting - Graves Disease Clinical Trials

Total Thyroidectomy Versus Thionamides in Patients With Moderate-to-Severe Graves' Ophthalmopathy

Start date: March 1, 2017
Phase: Phase 3
Study type: Interventional

Introduction: Graves disease (GD) is characterized by thyrotoxicosis and goiter, arising through circulating autoantibodies that bind to and stimulate the thyroid hormone receptor (TSHR). Graves' ophthalmopathy (GO) is characterized by inflammation, expansion of the extraocular muscles and an increase in retroorbital fat. There are currently three forms of therapies offered: anti-thyroid drugs (ATD) (thionamides), radioactive iodine (RAI) and total thyroidectomy (Tx). There is currently no consensus on the treatment of Grave's disease and GO. Objective: To examine the difference in the outcome of GO in patients with moderate-to-severe GO, who receive Tx versus further ATD after suffering their first relapse of GO or in which GO stays the same following the initial decrease in ATD therapy after 6 months. Methods: This prospective randomized clinical trial with observer blinded analysis will analyze 60 patients with moderate-to-severe GO who receive Tx versus ATD without surgery. Main outcome variables include: muscle index measurements via ultrasound and thyroid antibody levels. Additional outcome variables include: CAScore/NOSPECS score, superonasal index measurements via ultrasound and quality of life score.

NCT ID: NCT03013257 Completed - Graves Disease Clinical Trials

HIFU vs RAI in the Relapsed Graves' Disease

Start date: April 25, 2017
Phase: N/A
Study type: Interventional

Graves' disease (GD) is an autoimmune thyroid disorder caused by stimulating auto-antibodies to the thyrotrophin (TSH) receptor on thyroid follicular cells. It is the most common cause of hyperthyroidism and approximately 3% of women and 0.5% of men develop GD in their lifetime. RAI has been shown to be a cost-effective and safe therapy in patients with GD but with some disadvantages. In addition, despite its proven efficacy and safety, many patients do not wish to undergo RAI because of radiation fear and prefer to either continue ATDs or have surgery. High-intensity focused ultrasound (HIFU) is a non-invasive procedure that involves the application of a high-energy focused beam for thermal tissue ablation within a targeted zone. Similar to the principle of RAI (i.e. using ionizing radiation to ablate thyroid parenchyma and cause GD remission), we postulated that the heat energy generated from HIFU could also be used to ablate the thyroid parenchyma and cause GD remission. The idea of using heat energy to ablate thyroid parenchyma minimally invasively was recently reported using radiofrequency ablation but to our knowledge, we are one of the first (if not the first) group to propose using HIFU energy to ablate thyroid parenchyma as a definitive treatment for relapsed GD. Having obtained ethical approval, a pilot study was conducted to examine the efficacy and safety of HIFU as a treatment for relapsed GD. In the pilot study, all patients underwent a safe and successful HIFU ablation for relapsed GD. Based on the results of the pilot study, we hypothesize that a single HIFU treatment to the thyroid gland may be as effective as our standard outpatient fixed-dose of RAI (370MBq) in causing remission of GD at 6-month. If our hypothesis turns out to be true, HIFU could become a treatment option for patients who are indicated for RAI but do not wish to have it because of one reason or another. HIFU appears to induce a faster disease remission and lessen the need of deferring pregnancy and radiation precautions because of the absence of radioactivity.

NCT ID: NCT03009357 Completed - Graves Disease Clinical Trials

Clinical Application of Pulse Rate-monitoring Activity Trackers in Thyrotoxicosis

AT-thyro
Start date: November 2016
Phase:
Study type: Observational

The study is a single-center prospective cohort study of clinical application of continuously monitored data by wearable activity trackers in the patients with thyrotoxicosis. The purpose of the study is to evaluate the association between parameters of pulse rate, activity, and sleep from wearable activity trackers and the thyrotoxic status along with the treatment.

NCT ID: NCT02993302 Completed - Graves Disease Clinical Trials

Effects Of Oral Alfacalcidol On Maturation Of Dendritic Cells In Graves' Disease Patients

Start date: July 2014
Phase: Phase 2
Study type: Interventional

Maturity level of dendritic cells (DC) plays a pivotal role in initiating and regulating autoimmunity. In Graves' disease (GD), DCs have more active immune responses than those in healthy subjects. Our previous study demonstrated immunoregulatory effects of in vitro 1,25-D3 on maturation of DC in GD patients. This study aims to evaluate the effect of oral 1α-D3 on DC maturation in GD patients.

NCT ID: NCT02973802 Completed - Graves Disease Clinical Trials

ATX-GD-59 in Patients With Graves Disease Not Treated With Anti-thyroid Therapy

Start date: September 2016
Phase: Phase 1
Study type: Interventional

Phase 1 study to assess the safety and biological activity of ATX-GD-59 in patients with Graves Disease not currently treated with anti-thyroid therapy. This will be an open label dose titration involving injections on 10 occasions, each two weeks apart. After dosing is complete there will be a 12 week follow up period. Blood samples will be drawn throughout the study to monitor safety and the body's response to the injections. Thyroid function will be measured throughout the trial to monitor Graves disease progression.

NCT ID: NCT02904330 Completed - Graves' Disease Clinical Trials

K1-70 - A Study in Subjects With Graves' Disease

Start date: August 2016
Phase: Phase 1
Study type: Interventional

This study is the first time that K1-70 will be administered to humans. The principal aim of this study is to obtain safety and tolerability data when K1-70 is administered as an IM injection or as an IV infusion to subjects with Graves' disease. Current therapy for Graves' disease includes treatment with anti-thyroid drugs, destruction of the thyroid using radioiodine, or total surgical thyroidectomy. Beta-blockers and calcium antagonists may be used to control some of the symptoms of hyperthyroidism. K1-70 is a thyroid stimulating hormone receptor antagonist that may provide new in vivo diagnostic and therapeutic tools for the management of patients with Graves' disease, patients with thyroid cancer and patients who would benefit from controlling receptor activity.

NCT ID: NCT02798965 Completed - Graves Disease Clinical Trials

Prevalence of Circulating Parvovirus Genome in Recently Diagnosed Graves' Disease: a Case-control Study

GPCBasedow
Start date: December 2010
Phase: N/A
Study type: Interventional

Lymphocytic thyroiditis is the most common autoimmune disease, usually affecting young women. Although the aetiology and pathogenesis remain obscure, the most widely accepted hypothesis is an interaction between a genetic predisposition and an environmental trigger factor such as viral infection. Parvovirus infections have been proposed as trigger factors for Hashimoto's thyroiditis and Graves' disease.

NCT ID: NCT02772705 Recruiting - Hyperthyroidism Clinical Trials

Comparison of SUV Using SPECT/CT Between Grave's Disease Patients and Normal Humans

Start date: May 2016
Phase: N/A
Study type: Observational

The purpose of this study is to find out the capacity of standardized uptake value (SUV) using single-photo emission computed tomography and computed tomography (SPECT/CT) in diagnosing Grave's Disease (hyperthyroidism).

NCT ID: NCT02727738 Completed - Graves' Disease Clinical Trials

Treatment of Graves' Hyperthyroidism With Selenium Plus Methimazole

Start date: January 2014
Phase: N/A
Study type: Interventional

Evaluation of the efficacy of the combined treatment (methimazole plus selenium) in the control of hyperthyroidism as compared to methimazole alone in 30 Graves' disease (GD) untreated patients.

NCT ID: NCT02713256 Completed - Graves' Disease Clinical Trials

A Study to Evaluate the Safety and Effect of CFZ533 on Patients With Graves' Disease

Start date: April 19, 2016
Phase: Phase 2
Study type: Interventional

An open label study to evaluate the safety and efficacy of CFZ533 following 12 weeks treatment in patients with Graves' disease