A Phase II Study of the Safety and Effectiveness of rhTSH in Radioiodine Treatment for Patients With Differentiated Thyroid Cancer. (DTC)

NCT04447183 Phase 2 UNKNOWN

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.

Details

Lead sponsor	Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Phase	Phase 2
Status	UNKNOWN
Enrolment	120
Start date	2020-11-23
Completion	2024-10

Conditions

• Differentiated Thyroid Cancer

Interventions

• Recombinant Human Thyroid Stimulating Hormone for Injection(rhTSH)
• radioactive iodine

Primary outcomes

• Ablation success rate by Diagnostic Whole Body Scan (DxWBS) — at week 36
  In the THW state (TSH≥30mU/L), DxWBS showed the proportion of subjects who did not see radioactive iodine uptake in the thyroid gland.

Countries

China