NCT04964284CompletedPhase 3
rhTSH for Radioactive Iodine Remnant Ablation in Participants With Differentiated Thyroid Cancer (DTC)
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)
Source: ClinicalTrials.gov · Last updated 8 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 390 (actual)
- First submitted
- 6 Jul 2021
- Start date
- 6 Oct 2021
- Primary completion date
- 31 Jan 2026
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Diseases
- Thyroid cancer
- NCT number
- NCT04964284
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 390
- From 6 Oct 2021 to the primary completion date, 31 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- patients with recent history of 131I whole body scan within 2 weeks prior to randomized.
- Subjects who have participated in another clinical trial of a new drug or medical instrument within 1 months before screening.
Other illness
- patients with other malignancies (exception for in situ cervix uterine cancer, baso cellular skin cancer or breast cancer in remission)
- Subjects who are unsuitable to the trial in combination with other serious diseases, as identified by the investigator.
Other
- Pregnant or breast feeding women.
Who the study is looking for
- Subjects voluntarily sign the informed consent form (ICF).
- Age ≥ 18 years old, either male or female.
- Patients with diagnosed differentiated papillary or follicular thyroid carcinoma, including papillary-follicular variant, characterized as pT 1-3, N 0-1or Nx, and M0.
- Eastern Cooperative Oncology Group (ECOG) score of 0-2;
- Expected life expectancy is greater than 12 weeks;
- Patients with a total or near-total thyroidectomy within 12 months prior to randomized.
- Low iodine diet for two weeks prior to randomized.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.