The Safety and Effectiveness of rhTSH in Radioiodine Treatment for Patients With Differentiated Thyroid Cancer.

• Status: Recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Treatments: Hormones; Iodine

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.