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Thyrogen · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | OTHER | - |
| Name | Type | Description |
|---|---|---|
| Thyrogen (thyrotropin alfa for injection) | DRUG | No reference therapy was given. All patients in this follow-up study received Thyrogen. Thyrogen 0.9 mg was administered intramuscularly (IM) in the buttock on 2 consecutive days. For WBS and static neck imaging, each patient received 4 mCi (148 MBq) ± 0.4 mCi 131I PO. |
Inclusion Criteria: * Committed to follow the protocol requirements, as evidenced by providing written informed consent before any study-related procedures are performed and within 28 days prior to Day 1; * Completed the THYR-008-00 study; * A negative serum pregnancy test within 8 days prior to th...
Thyrogen is used in the treatment of differentiated thyroid cancer and thyroid neoplasms. It is administered to patients following thyroidectomy to enable the successful ablation of thyroid remnant tissue when combined with radioactive iodine (131I) therapy. The drug is given to euthyroid patients as an alternative to the hypothyroid state typically required for this procedure.
Thyrogen is a small molecule that works by stimulating thyroid-stimulating hormone (TSH) receptors. This stimulation allows for the uptake of radioactive iodine by thyroid remnant tissue, facilitating its destruction. By mimicking the effects of TSH, Thyrogen enables effective ablation without the need for patients to become hypothyroid.
Thyrogen is developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol SNY. Sanofi is responsible for the research, development, and commercialization of this drug for the treatment of differentiated thyroid cancer and thyroid neoplasms.
Thyrogen is in Phase 3 clinical development. It has completed Phase 3 trials, including a study comparing the safety and successful ablation of thyroid remnant in post-thyroidectomized euthyroid patients versus hypothyroid patients. The drug is investigational and has not been approved by regulatory authorities based on the available data.
Thyrogen has been studied in two Phase 3 clinical trials. The first, NCT00196729, compared the safety and successful ablation of thyroid remnant in euthyroid patients administered Thyrogen versus hypothyroid patients following 131I administration, enrolling 63 participants. The second, NCT00295763, was a follow-up study of thyroid cancer patients who participated in the previous trial, enrolling 61 participants.
Thyrogen is the brand name for the drug known generically as thyrotropin alfa. It is a recombinant form of human thyroid-stimulating hormone (TSH) used in the management of differentiated thyroid cancer. The drug is also referred to by its chemical name, but Thyrogen is the primary brand name used in clinical practice.