Graves' Disease

This research aims to study children with hyperthyroidism by collecting information on their diagnosis, treatment, and long-term follow-up. The study focuses on understanding the clinical features, treatment effects, side effects, remission, and relapse of hyperthyroidism in children. It also investigates factors that predict the response to antithyroid drug treatment and explores risks linked to adverse reactions from these drugs. The study observes children treated with methimazole (MMI), a drug given initially at 0.2-0.8 mg per kilogram per day. The dose is gradually reduced and adjusted based on thyroid hormone test results to maintain normal thyroid function. This observational study includes both retrospective and prospective data collection without any intervention. Participants will be monitored over time to assess remission, defined as normal thyroid function without methimazole for at least 12 months, and adverse effects such as neutropenia, liver dysfunction, rash, and muscle or joint pain. Relapse after stopping methimazole will also be tracked. The study involves clinical evaluations, biochemical tests, and long-term follow-up lasting up to 10 years to understand treatment outcomes and safety.

Researchers are evaluating the efficacy and safety of IBI311, also known as Teprotumumab N01 injection, in adults with inactive thyroid eye disease (TED). This multicenter, randomized, double-masked, placebo-controlled Phase III clinical trial involves approximately 111 participants to assess how well IBI311 works compared to a placebo. The study aims to better understand treatment effects on eye protrusion and other disease symptoms over a long follow-up period. Participants will be randomly assigned to receive either IBI311 or a placebo in a 2:1 ratio. The study has two parts lasting about 64 weeks in total. Part 1 includes a screening and treatment phase lasting around 28 weeks with masked treatment. Part 2 is an open follow-up or treatment period lasting up to 36 weeks. The treatments are given by injection, and participants will be monitored closely throughout both parts. During the trial, participants will undergo regular assessments including eye examinations measuring proptosis (eye protrusion), diplopia (double vision), and clinical activity scores. Safety and tolerability of IBI311 will be evaluated through laboratory tests, imaging, and questionnaires such as the Graves' Ophthalmopathy Quality of Life survey. The primary outcome is the proptosis response rate at 24 weeks. Participants will be followed for safety and disease activity for up to about one year after treatment.

Researchers are evaluating microwave ablation (MWA) as a minimally invasive treatment option for patients with relapsed Graves' disease who have previously been treated with anti-thyroid drugs but experienced a return of symptoms. Graves' disease is the most common cause of hyperthyroidism, and conventional treatments include anti-thyroid drugs, radioiodine, and surgery. However, these treatments have drawbacks such as side effects, risk of worsening eye symptoms, or surgical complications, which has led to interest in alternative therapies like MWA. In this study, all participants will receive ultrasound-guided MWA treatment using a device that inserts a microwave antenna into the thyroid gland to apply thermal energy and ablate the tissue. The procedure targets the entire thyroid gland, including both lobes, the isthmus, and the pyramidal lobe. This approach avoids surgical scars and preserves the organ, and it is performed as an outpatient procedure. The study does not involve comparison groups but focuses on evaluating this treatment. During the study, participants will be monitored for remission of Graves' disease six months after the procedure. Researchers will also measure changes in quality of life and thyroid gland volume at six months. The study includes follow-up assessments to evaluate treatment outcomes and safety. Participants can expect clinical evaluations and ultrasound examinations as part of their involvement. The total participation duration extends at least six months post-treatment.

Researchers are studying the use of a diagnostic device called ISAR-M THYRO to detect bleeding early after thyroid surgery. Postoperative bleeding occurs in 0.6 to 4% of patients, with most cases happening within the first 48 hours and potentially leading to serious complications or death. The study aims to improve early detection by continuously measuring neck pressure, which may indicate bleeding earlier than current symptom-based methods. Participants will have the ISAR-M THYRO device applied after thyroid surgery to continuously measure and digitally document neck pressure for up to 48 hours. The device includes alarms and a display that can be turned off. This observational study focuses on collecting data to assess the device's ability to detect bleeding early through pressure monitoring during the critical postoperative period. During the study, participants will be monitored for neck pressure changes using the device, and researchers will evaluate the sensitivity and specificity of bleeding detection within 48 hours after surgery. Safety of the device will be assessed for one month. The study helps understand if continuous pressure monitoring can provide timely alerts to reduce serious complications after thyroid surgery.

This research aims to evaluate the effects of thyroid hormone supplementation in patients undergoing hemodialysis who have elevated thyrotropin (TSH) levels, a common complication in chronic kidney disease. Previous studies have shown that higher TSH levels are linked to poorer quality of life and increased cardiovascular risks in these patients. The trial seeks to clarify whether levothyroxine treatment can improve patient-centered outcomes and cardiovascular health, as well as its metabolic effects in this population. Participants will be randomly assigned to receive either levothyroxine or a matching placebo for 24 weeks. Initial doses depend on their TSH levels, with adjustments after 8 and 16 weeks based on follow-up TSH measurements, aiming to maintain TSH within a target range. Both groups undergo similar pill titration schedules to maintain study balance. The trial is double-blind and placebo-controlled to ensure unbiased results. During the study, participants will have assessments of quality of life, coronary artery calcification, physical performance, endothelial function, vascular markers, body fat, muscle strength, heart function, and energy expenditure at baseline and after 24 weeks. These evaluations help researchers determine the impact of levothyroxine on health-related quality of life and cardiovascular parameters. The total study participation spans approximately six months with regular monitoring.

Researchers are evaluating the safety, tolerability, and effectiveness of AMG 732 in both healthy individuals and people with moderate-to-severe active Thyroid Eye Disease (TED). The study is divided into two parts: Part A focuses on single subcutaneous doses to assess safety, while Part B investigates multiple doses to evaluate efficacy in improving eye symptoms related to TED. This study includes participants aged 18 to 65 years and is sponsored by Amgen. Participants in Part A receive single ascending doses of AMG 732 or placebo through subcutaneous injections in six different groups. Part B participants receive either low, medium, or high doses of AMG 732 or placebo, also by subcutaneous injection, over approximately six months. The study involves randomized assignment to treatment groups and uses a double-masked design to ensure unbiased results. Throughout the study, participants undergo various assessments including monitoring of adverse events, blood tests to measure AMG 732 levels and antibodies, eye examinations measuring proptosis, and quality of life questionnaires related to visual function and appearance. Safety and treatment effects are followed for up to 36 weeks in Part A and up to 48 weeks in Part B. The total duration and detailed evaluations aim to provide comprehensive data on AMG 732’s impact on TED and healthy subjects.

Researchers are evaluating the safety and tolerability of single and multiple increasing doses of GenSci098 given under the skin in patients with active thyroid eye disease (TED) related to Graves' disease. This Phase 1 clinical trial aims to understand how the body processes this drug and to monitor for any side effects. The study is sponsored by Changchun GeneScience Pharmaceutical Co., Ltd. Participants will receive subcutaneous injections of GenSci098 at one of five dose levels (15mg, 45mg, 90mg, 180mg, or 270mg) or a matching placebo. The study includes two parts: a single ascending dose (SAD) phase where participants receive one dose, and a multiple ascending dose (MAD) phase where participants receive repeated doses. The study uses a randomized and quadruple-blind design to compare GenSci098 and placebo. During the study, participants will be monitored for adverse events through physical exams, vital signs, laboratory tests, and ECGs over periods of up to 169 days in the SAD part and 281 days in the MAD part. Researchers will also measure how GenSci098 moves through and acts in the body, including antibody responses. Participants will be asked to comply with study treatments and assessments until the study ends.

Researchers are evaluating GenSci098, a drug given as single ascending subcutaneous doses, in adults with Graves' Disease to study its safety and tolerability. This phase 1 clinical trial aims to understand the effects of GenSci098 on patients with confirmed diffuse toxic goiter and abnormal thyroid function. The study is sponsored by Changchun GeneScience Pharmaceutical Co., Ltd. and focuses on monitoring adverse events and drug behavior in the body. Participants will receive only one dose of GenSci098 injected under the skin at one of several dose levels. The study includes a follow-up period lasting 141 days, during which safety and tolerability will be assessed. There is no placebo or control group, and the trial is not blinded. The focus is on careful monitoring after the single dose administration. Throughout the study, participants will undergo physical exams, vital sign checks, laboratory tests, and 12-lead electrocardiograms to detect any adverse effects. Researchers will track the incidence and severity of adverse events during the 141-day observation window. Participants must comply with the follow-up schedule and study requirements to ensure accurate safety monitoring and data collection.

Researchers are evaluating the use of online outpatient follow-up compared to traditional offline follow-up for patients who have undergone surgery for papillary thyroid cancer. This randomized controlled trial aims to assess the adherence to outpatient procedures over a 12-month period. The study includes adults between 18 and 90 years old who have had thyroid surgery and are able to communicate in Chinese and use the internet for visits. Participants are randomly assigned to one of two groups: one group uses the Huayitong app for their post-operative follow-up, while the other group attends standard in-person outpatient clinics. The study will monitor participants through three follow-up visits at 1, 3, and 6 months after surgery. Participants assigned to online visits may switch to offline visits or withdraw from the trial if technical issues arise or additional medical care is needed. During the study, investigators collect demographic and medical information, details of symptoms and treatment, patient satisfaction, and other relevant data through questionnaires and electronic medical records. Safety is monitored through a review of medical records and participant surveys 30 days after the final follow-up. The main outcome measured is adherence to outpatient procedures, with secondary outcomes including general quality of life.

Researchers are evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GenSci136 in healthy adult volunteers. This randomized, double-blind, placebo-controlled Phase 1 trial aims to study a single subcutaneous injection of GenSci136. The study focuses on how the drug behaves in the body and its effects, while monitoring for any adverse reactions over time. Participants will receive single ascending doses of GenSci136 or a placebo administered under the skin. The study is designed with dose escalation to evaluate different amounts of the drug. Both the experimental drug and placebo are given through subcutaneous injections in a controlled setting. During the study, participants will be closely observed from Day 1 through Day 113. Researchers will monitor for treatment-emergent adverse events and serious adverse events to assess safety. Blood samples will be collected to measure drug concentration, its maximum level, time to reach maximum level, elimination half-life, and other pharmacokinetic parameters. In addition, changes in specific biomarkers related to immune response will be measured. The trial involves regular visits and assessments over approximately 16 weeks to ensure thorough monitoring and data collection.