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Completed
NCT04447183
rhTSH for Radioactive Iodine Remnant Ablation in Differentiated Thyroid Cancer
Conditions: Differentiated Thyroid Cancer
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 123
Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Location: Peking Union Medical College Hospital Beijing Beijing Municipality
Summary
This is a randomized, open, parallel controlled, multi-center clinical trial; 120 subjects were randomly assigned to the test group and the control group according to 3:1.
Eligibility Criteria
Inclusion Criteria:
* Pathological diagnosis of differentiated thyroid cancer, including papillary thyroid cancer (including papillary carcinoma follicular subtype), follicular thyroid cancer, and Hurthle cell thyroid cancer;
* Patients who were at 18\~75 years old (male or female).
* Patients with a total or near-total thyroidectomy within 12 weeks prior to enrollment and plan to performing radioactive iodine((131)Ⅰ) thyroid remnant ablation.
* Serum TSH ≤ 0.5 mU/L;
* Women of childbearing age are HCG-negative;
* Low iodine diet before enrollment for more than 4 weeks;
* Patients are voluntarily enrolled, and written informed consent forms can be used for treatment and visits as required by the program.
Exclusion Criteria:
* Any significant clinical and laboratory abnormalities (eg, severe cardiopulmonary disease, hepatic insufficiency, renal function Incomplete, congestive heart failure, advanced lung disease or advanced cardiovascular and cerebrovascular disease, active infection);
* Patients who have used any water-soluble radiographic contrast agent intravenously, underwent intrathecal iodine angiography or gallbladder iodine imaging within 3 months before administration;
* Taken/eaten within 4 weeks prior to administration Drugs/foods that affect iodine uptake or metabolism, such as multivitamins, glucocorticoids, diuretics, lithium, thiouracil, tazobactam, algae, iodine (except thyroid hormone replacement therapy);
* Before administration Stroke, unstable angina (CCS class II or higher), atrial fibrillation or medication (within beta blocker or digoxin) within 6 months Patients with a history of arrhythmia;
* Pregnant or lactating women;
* Patients who are allergic to rhTSH and its excipients;
* Patients with positive infection-related tests : Includes hepatitis C、syphilis and AIDS;
* Participated in any drug or medical device clinical trial within 1 month prior to the trial.
Source: ClinicalTrials.gov (NCT04447183). StuddyBuddy aggregates publicly available trial information.