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Clinical Study of rhTSH in the Treatment of Patients With Thyroid Cancer After Resection of Stage I/II

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04137185
Recruitment Status : Recruiting
First Posted : October 23, 2019
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Brief Summary:
Dose-increasing tolerance, pharmacokinetics, and iodine uptake effects of recombinant human thyroid stimulating hormone in patients after thyroidectomy

Condition or disease Intervention/treatment Phase
Differentiated Thyroid Cancer Drug: Recombinant Human Thyroid Stimulating Hormone for Injection Phase 1 Phase 2

Detailed Description:
This phase 1 and 2 study of rhTSH, To observe the safety and tolerability characteristics of different doses of rhTSH in patients after thyroidectomy, and to observe the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) that may occur in the set dose group.The study is a Non-randomized, open, one-arm study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: I/II Clinical Study of Dose-tolerance, Pharmacokinetics, and Iodine Uptake in Recombinant Human Thyroid Stimulating Hormone in Patients After Thyroidectomy
Actual Study Start Date : June 10, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1
0.9mg, q.d., for 1 day.
Drug: Recombinant Human Thyroid Stimulating Hormone for Injection
Each was dissolved in 1.2 mL of sterile water for injection to obtain a solution containing 0.9 mg/mL rhTSH, which was intramuscularly injected according to the dosing schedule.

Experimental: Cohort 2
0.9mg, q.d., for 2 day.
Drug: Recombinant Human Thyroid Stimulating Hormone for Injection
Each was dissolved in 1.2 mL of sterile water for injection to obtain a solution containing 0.9 mg/mL rhTSH, which was intramuscularly injected according to the dosing schedule.

Experimental: Cohort 3
1.8mg, q.d., for 1 day.
Drug: Recombinant Human Thyroid Stimulating Hormone for Injection
Each was dissolved in 1.2 mL of sterile water for injection to obtain a solution containing 0.9 mg/mL rhTSH, which was intramuscularly injected according to the dosing schedule.

Experimental: Cohort 4
1.8mg, q.d., for 2 day.
Drug: Recombinant Human Thyroid Stimulating Hormone for Injection
Each was dissolved in 1.2 mL of sterile water for injection to obtain a solution containing 0.9 mg/mL rhTSH, which was intramuscularly injected according to the dosing schedule.

Experimental: Extension
0.9mg, q.d., for 2 day(predicted).
Drug: Recombinant Human Thyroid Stimulating Hormone for Injection
Each was dissolved in 1.2 mL of sterile water for injection to obtain a solution containing 0.9 mg/mL rhTSH, which was intramuscularly injected according to the dosing schedule.




Primary Outcome Measures :
  1. MTD [ Time Frame: up to 7 days ]
    the maximum tolerathed dose


Secondary Outcome Measures :
  1. Cmax [ Time Frame: up to 5 days ]
    maximum serum thyrotropin concentrations

  2. AUC [ Time Frame: up to 5 days ]
    area under curve of serum thyrotropin concentration

  3. Serum Tg [ Time Frame: up to 7 days ]
    serum Tg levels

  4. radioiodine uptake [ Time Frame: up to 8 weeks ]
    whole body radioiodine imaging after rhTSH administration and after thyroid hormone withdrawal

  5. adverse event [ Time Frame: up to 8 weeks ]
    classification and degree of adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04137185


Contacts
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Contact: Lin Yan Song, MD 13671116837 linys@pumch.cn

Locations
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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China
Contact: Lin Yan Song, MD         
Sponsors and Collaborators
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

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Responsible Party: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier: NCT04137185    
Other Study ID Numbers: ZGTSH001
First Posted: October 23, 2019    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs