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

NCT04447183 | Unknown Phase 2

• 1 other identifier: ZGTSH002
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Differentiated Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• Ablation success rate by Diagnostic Whole Body Scan (DxWBS)

  In the THW state (TSH≥30mU/L), DxWBS showed the proportion of subjects who did not see radioactive iodine uptake in the thyroid gland.

  at week 36

Secondary Outcomes (2)

• Serum thyroglobulin (Tg) levels

  at week 36

• Adverse Event

  up to week 40 ± 7 day

Study Arms (2)

Test group

EXPERIMENTAL

The test group of patients who took thyroid hormone medicine and were euthyroid \[i.e. their thyroid stimulating hormone (TSH) levels are normal\], and received injections of Thyrogen (0.9 mg daily on two consecutive days) followed by oral radioiodine.

Drug: Recombinant Human Thyroid Stimulating Hormone for Injection(rhTSH); Other: radioactive iodine

Control group

EXPERIMENTAL

The control group of patients did not take thyroid hormone medicine so that they were hypothyroid (i.e. their TSH levels were high,TSH≥30mU/L), and were given oral radioiodine.

Other: radioactive iodine

Interventions

Recombinant Human Thyroid Stimulating Hormone for Injection(rhTSH) DRUG

rhTSH: 0.9 mg IM daily on two consecutive days;radioactive iodine: 30mCi±1.5mCi or 1.11GBq of 131I oral

Also known as: radioactive iodine

Test group

radioactive iodine OTHER

radioactive iodine: 30mCi±1.5mCi or 1.11GBq of 131I oral

Control group; Test group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Interventions

Thyrotropin Alfa; Injections

Intervention Hierarchy (Ancestors)

Thyrotropin; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Yansong Lin, PhD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomized, open, parallel controlled, multi-center clinical trial

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 25, 2020
• Study Start: November 23, 2020
• Primary Completion: August 1, 2024
• Study Completion: October 1, 2024
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)