A Phase 3 interventional study of rhTSH and Radioiodine (131I) in Differentiated Thyroid Cancer, sponsored by Suzhou Zelgen Biopharmaceuticals Co.,Ltd. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Phase 3, Interventional, and Treatment
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.
Suzhou Zelgen Biopharmaceuticals Co.,Ltd is the lead sponsor of 82 studies on the registry; 31 are open to participants now.
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Patients received thyroid hormone suppression therapy (Euthyrox) . rhTSH (0.9 mg) was administered intramuscularly (IM) once daily (qd) for 2 days. Twenty-four hours following the second dose of rhTSH, an ablative activity of 131I (30 mCi±1.5 mCi) was administered.
Biological: rhTSH · Radiation: Radioiodine (131I)
After randomization, patients with thyroid hormone withdrawal therapy(i.e. Stop taking thyroid hormone for 14 days, and then monitor the level of thyroid-stimulating hormone every week). When TSH\>30mU/L, an ablative activity of 131I (30 mCi±1.5 mCi) was administered.
Radiation: Radioiodine (131I)
rhTSH (0.9 mg) was administered intramuscularly (IM) once daily (qd) for 2 days. Twenty-four hours following the second dose of rhTSH
Also known as: Recombinant human thyroid-stimulating hormone
Patients were given an ablative dose of 131I (30 mCi±1.5 mCi).
The rate of successful postoperative thyroid ablation
Patients were considered successfully ablated if there was no visible thyroid bed uptake on the scan
Time frame: 8 months later by a rhTSH stimulated radioiodine scan
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Suzhou Zelgen Biopharmaceuticals Co.,Ltd