Hyperthyroidism

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.

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 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 how well multiparametric ultrasound mpUS imaging can examine and provide information about cancerous and non-cancerous tissues. This study compares mpUS, which combines different ultrasound methods to show detailed tissue structure and blood flow, with standard ultrasound and other tests. The goal is to see if mpUS can offer a more accurate assessment, especially for pancreatic cancer and thyroid nodules. Participants will receive additional mpUS imaging during their standard ultrasound procedures, which adds about 5 to 15 minutes of scan time. There are three groups patients at high risk for pancreatic cancer undergoing endoscopic ultrasound, patients with pancreatic ductal adenocarcinoma receiving endoscopic ultrasound-guided biopsies, and patients having thyroid nodule biopsies. Healthy volunteers without cancer or thyroid nodules may also join. During the study, participants will undergo mpUS imaging alongside their usual care scans. Researchers will collect the extra ultrasound data to evaluate the feasibility of mpUS imaging. The main outcome is assessing how well mpUS works during the imaging procedures. This study is non-randomized, has no masking, and will continue until November 2027. Participants may be followed up as agreed, and the total added scan time is brief.

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 how efgartigimod affects thyroid function in adults with Graves Disease GD. This study aims to assess the safety, tolerability, and immune response of efgartigimod, including its effects on antibody levels and how the body processes the drug. The trial is a Phase 3 study designed to understand the treatments impact on controlling GD symptoms and improving thyroid hormone levels. Participants are assigned to different groups in a randomized, parallel design. During the first part part A, participants receive either efgartigimod PH20 SC via prefilled syringe or a placebo in a double-blinded manner. The second part part B continues with either efgartigimod or placebo treatment and observation. In the third part part C, all participants receive open-label efgartigimod treatment. The total participation time ranges from 63 to 135 weeks, depending on individual responses. Throughout the study, participants undergo regular assessments including thyroid hormone levels fT3, fT4, TSH, antibody measurements, and safety monitoring. Researchers will track how many participants achieve normal thyroid function without antithyroid drugs by week 24 and over longer periods. The study also evaluates changes in quality of life and immune system markers. Participants receive ongoing monitoring to observe treatment effects and any adverse events during the extended study duration.

Researchers are evaluating the effects of efgartigimod on thyroid function in adults with Graves Disease, focusing on its safety, how it is processed in the body, and its impact on antibody levels and the immune system. This Phase 3 study involves a randomized, double-masked, placebo-controlled design to better understand treatment outcomes for participants whose disease is not well controlled with antithyroid drugs. Participants may receive efgartigimod PH20 SC or a placebo via subcutaneous injection using a prefilled syringe during the first two parts of the study, which include a double-blinded treatment period and a treatmentobservation period. In the third part, participants receive open-label efgartigimod treatment. The study spans between 63 and 135 weeks depending on each participants response to treatment. Throughout the study, participants undergo regular assessments of thyroid hormone levels, antibody levels, and immune response markers. Safety is monitored continuously, including tracking adverse events. The primary outcome measures focus on the percentage of participants achieving normal thyroid hormone levels without antithyroid drugs at 24 weeks. Additional evaluations include quality of life questionnaires and long-term monitoring of treatment effects and tolerability.

Researchers are conducting a multicenter, Phase 3, randomized, double-blinded, placebo-controlled trial to study the effects of ZL-1109 on Chinese participants with active Thyroid Eye Disease TED. This study aims to assess the efficacy, safety, and tolerability of ZL-1109 in improving symptoms of TED, a condition that affects the eyes. The trial is sponsored by Zai Lab Shanghai Co., Ltd. and focuses on participants aged 18 to 75 years with moderate to severe and active TED. Participants will be randomly assigned to receive either ZL-1109 or a matching placebo through subcutaneous injections. The study includes a screening period of up to 28 days, followed by a 24-week double-blinded treatment period. After this, participants may enter an extension phase, lasting either up to 52 weeks for those who decline open-label treatment or up to 70 weeks for those who agree to receive open-label ZL-1109 if they do not respond initially. Dosing regimens vary, with ZL-1109 given every 4 or 8 weeks during the randomized period and every 4 weeks during the open-label extension. Throughout the trial, participants will undergo assessments including measurement of proptosis eye bulging, Clinical Activity Score CAS, and diplopia double vision responses at Week 24. Researchers will monitor treatment safety and tolerability, with follow-up visits during the extension period. The total participation duration depends on response status and consent to open-label treatment, ensuring detailed evaluation of outcomes and safety over an extended timeframe.

Researchers are evaluating IMVT-1402 in a global, randomized, double-blind, placebo-controlled Phase 2b study for adults with Graves disease GD who remain hyperthyroid despite antithyroid drug ATD treatment. The study aims to assess the efficacy, safety, and tolerability of IMVT-1402 in this population. Participants will receive one of two doses of IMVT-1402 or a placebo for 26 weeks. The study includes two experimental groups with different doses of IMVT-1402 and a placebo comparator group. Treatments are given over the same 26-week period to evaluate their effects. During the study, participants will be monitored to see if they become euthyroid and are able to stop ATD by Week 26. Researchers will measure thyroid hormone levels such as triiodothyronine T3 and free thyroxine FT4 at various time points, including Weeks 2, 4, and 26. Safety and tolerability will also be assessed throughout the trial, which is expected to complete in May 2027.