Clinical Trials

Over the years, Genzyme has maintained its commitment to patients with thyroid cancer and other endocrine disorders. One of the ways this commitment is shown is through clinical trials with Thyrogen^®(thyrotropin alfa for injection).The uses described in these preliminary studies are investigational, and not currently approved by the FDA. For more information, please see the important safety information below.

Phase 1 Study: Thyrogen in patients with nontoxic multinodular goiter

Genzyme is running a multicenter phase I clinical study to determine a safe dose of Thyrogen when used to increase the effectiveness of radioiodine therapy in patients with nontoxic multinodular goiter.

Nontoxic multinodular goiter (NT-MNG) is a common condition that involves the enlargement of the thyroid gland. Enlarged glands can grow and can potentially lead to a variety of complications such as neck swelling, compression of local structures — resulting in difficulty breathing or swallowing — neck pain, and thyrotoxicosis, if the glands become autonomously functioning.

Indications for treatment of NT-MNG include cosmetic reasons, relief of compressive symptoms, and prevention of thyrotoxicosis. Treatments for NT-MNG include surgical resection of the thyroid gland, radioablative therapy, and thyroid hormone suppression therapy.^[1] These treatment options can be associated with unwanted side effects and can be very costly.

Radioiodine therapy has been shown to be effective in reducing the size of the enlarged gland. However, in some patients, the thyroid gland does not take up sufficient radioiodine for this treatment to be effective. In the follow-up of well-differentiated thyroid cancer patients, Thyrogen has been shown to stimulate the thyroid gland to take up radioiodine. This phase 1 trial is designed to evaluate the safety of using Thyrogen to stimulate radioiodine uptake in patients with NT-MNG.

For more information, please see the full prescribing information (PDF).

Phase 1 Study: Pharmacokinetics and safety profile in healthy subjects of Thyrogen and a new modified-release rhTSH formulation

A Phase I study began in 2005 to compare the pharmacokinetics and safety of modified release thyroid stimulating hormone with Thyrogen in healthy normal subjects. The clinical plan is intended to investigate whether the new formulation of rhTSH will have characteristics that would be favorable for its use in patients with nodular goiters.

Nodular goiters are clinically palpable enlargements of the thyroid gland resulting from excessive growth and/or structural changes in thyroid tissue. Nodular goiter patients may be euthyroid, hypothyroid, or hyperthyroid; gradual onset of hyperthyroidism is common.

If you have questions about clinical trials, please contact Medical Information by phone at 800.745.4447, by fax at 800.737.3642, or by email.

References

1. Henneman G. Multinodular goiter. In DeGroot LJ, Henneman G, eds. Thyroid and its Diseases, Chapter 17. Available at: www.thyroidmanager.org/Chapter17/17-frame.htm. Accessed July 27, 2005.