Status:
UNKNOWN
The Safety and Effectiveness of rhTSH in Radioiodine Treatment for Patients With Differentiated Thyroid Cancer.
Lead Sponsor:
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Conditions:
Differentiated Thyroid Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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.
Detailed Description
This study was conducted in patients with differentiated thyroid cancer who had undergone near-total thyroidectomy. After surgery patients were randomized to one of two methods of performing thyroid r...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04447183
Start Date
November 23 2020
End Date
October 1 2024
Last Update
October 23 2023
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730