Status:
COMPLETED
Clinical Trial of Dose-tolerance, Pharmacokinetics and Iodine Uptake For rhTSH In Post-thyroidectomized Patients
Lead Sponsor:
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Conditions:
Differentiated Thyroid Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
Phase I/II Clinical Trial of Dose-tolerance, Pharmacokinetics and Iodine Uptake Effects For Recombinant Human Thyroid Stimulating Hormone In Post-thyroidectomized Patients
Detailed Description
This phase I/II study of rhTSH, To observe the safety and tolerability characteristics of different doses of rhTSH In Post-thyroidectomized Patients, and to observe the dose-limiting toxicity (DLT) an...
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;
- Screening ages 18-75 (including 18 Age and 75 years old, male or female;
- Weight 45kg-80kg (including 45kg and 80kg, limited to the dose escalation test);
- Complete thyroidectomy or near total resection, and plan to start 131I diagnosis or ablation Patients
- Serum TSH ≤ 0.5 mU/L;
- Women of childbearing age are HCG-negative and must continue contraception until more than 3 months after the end of the trial;
- Subjects (including partners) from 2 weeks prior to dosing to the last study drug There is no pregnancy plan within 3 months after the drug and voluntary effective contraceptive measures are taken. For specific contraceptive measures, see Appendix 3;
- Normal ECG. Intermittent atrial premature beats, supraventricular tachycardia (SVT) or supraventricular block-independent PR interval abnormalities, right bundle branch block, mild sinus bradycardia (asymptomatic, and no treatment required) Can be grouped;
- 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
- Patients who are not eligible for THST withdrawal due to pituitary disease or other diseases;
- Patients not eligible for 131I diagnosis or treatment;
- 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);
- Hypertensive patients who cannot be reduced to the following range due to medical treatment (systolic blood pressure \<140 mmHg, diastolic blood pressure \<90 mmHg);
- Patients who have used any water-soluble radiographic contrast agent intravenously within 4 weeks before administration;
- Patients who underwent intrathecal iodine angiography or gallbladder iodine imaging within 3 months prior to 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;
- a history of drug use and/or alcohol abuse within 3 months prior to dosing;
- patients who are allergic to rhTSH and its excipients;
- patients with positive infection-related tests : Includes hepatitis C and AIDS;
- Participated in any drug or medical device clinical trial within 1 month prior to the trial;
- Those who were unable to participate in the trial as judged by the investigator.
Key Trial Info
Start Date :
June 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 29 2020
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04137185
Start Date
June 10 2019
End Date
December 29 2020
Last Update
March 6 2024
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730