Study to Evaluate the Dose, Safety and Effectiveness of Modified-Release Recombinant Human Thyroid Stimulating Hormone (MRrhTSH) When Used in Conjunction with Radioiodine for the Treatment of Multinodular Goiter

Genzyme Europe BV0 sites99 target enrollmentJune 22, 2007

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: odular goiter are clinically recognizable enlargements of the thyroid gland characterized by excessive growth and structural and or functional transformation of one or several areas within the normal thyroid tissue.
Sponsor: Genzyme Europe BV
Enrollment: 99
Status: Active, not recruiting
Last Updated: 13 years ago

No summary available.

Registry

who.int

Start Date

June 22, 2007

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\.Adults aged 35 – 80 years old, inclusive.
•2\.Clinical diagnosis of multinodular goiter, judged clinically and by ultrasound at Screening to be at least 40 mL, but less than or equal to 140 mL in size.
•3\.Clinically free of thyroid cancer as determined by Fine Needle Aspiration (FNA) of all dominant and/or highly suspicious cold nodules in the goiter and cytology reports as negative for thyroid cancer. (Note: Results of FNA and cytology reports that were performed within 18 months prior to commencing Screening procedures and meet these criteria are acceptable for inclusion).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range

•1\.History of thyroid cancer.
•2\.Previous partial or near total thyroidectomy.
•3\.Clinical history, signs or symptoms that make thyroid cancer a higher than usual probability, such as positive immediate family history of thyroid cancer, history of head or neck irradiation, a stone\-hard nodule or suspicious growth of a nodule in recent months, palpable cervical lymph nodes or nodes that on ultrasound have features suspicious for metastases (unless ruled out by biopsy or FNA).