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rhTSH for Radioactive Iodine Remnant Ablation in Participants With Differentiated Thyroid Cancer (DTC)
Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Summary
This study was conducted in patients with differentiated thyroid cancer who had undergone total/near-total thyroidectomy. After surgery patients were randomized to one of two methods of performing thyroid remnant ablation. One 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 rhTSH (0.9 mg daily on two consecutive days) followed by oral radioiodine. The second group of patients did not take thyroid hormone medicine so that they were hypothyroid (i.e. their TSH levels were high), and were given oral radioiodine.
Official title: A Phase 3, Randomized, Open-Label, Multicenter, Parallel-Group Study to Evaluate the Efficacy and Safety of Recombinant Human Thyrotropin (rhTSH) for Radioactive Iodine (RAI) Remnant Ablation in Postoperative Participants With Differentiated Thyroid Cancer (DTC)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
390
Start Date
2021-10-06
Completion Date
2026-01-31
Last Updated
2026-09-08
Healthy Volunteers
No
Conditions
Interventions
rhTSH
rhTSH (0.9 mg) was administered intramuscularly (IM) once daily (qd) for 2 days. Twenty-four hours following the second dose of rhTSH
Radioiodine (131I)
Patients were given an ablative dose of 131I (30 mCi±1.5 mCi).
Locations (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China