Clinical Trial of Dose-tolerance, Pharmacokinetics and Iodine Uptake For rhTSH In Post-thyroidectomized Patients

Differentiated Thyroid Cancer Clinical Trial

Official title:

Phase I/II Clinical Trial of Dose-tolerance, Pharmacokinetics and Iodine Uptake For Recombinant Human Thyroid Stimulating Hormone In Post-thyroidectomized Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04137185
• Other study ID #: ZGTSH001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 10, 2019
• Est. completion date: December 29, 2020

Study information

• Verified date: March 2024
• Source: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase I/II Clinical Trial of Dose-tolerance, Pharmacokinetics and Iodine Uptake Effects For Recombinant Human Thyroid Stimulating Hormone In Post-thyroidectomized Patients

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) and maximum tolerated dose (MTD).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 29, 2020
• Est. primary completion date: December 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;
• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Differentiated Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• Recombinant Human Thyroid Stimulating Hormone for Injection
rhTSH was dissolved in 1.2 mL of sterile water for injection to obtain a solution containing 0.9 mg/mL rhTSH.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MTD	the maximum tolerated dose	up to 7 days
Secondary	Cmax	maximum serum thyrotropin concentrations	up to 5 days
Secondary	AUC	area under curve of serum thyrotropin concentration	up to 5 days
Secondary	Serum Tg	serum Tg levels	up to 7 days
Secondary	radioiodine uptake	whole body radioiodine imaging after rhTSH administration and after thyroid hormone withdrawal	up to 8 weeks
Secondary	adverse event	classification and degree of adverse events	up to 8 weeks