NCT00454220

Study to Determine the Dose, the Safety and Effectiveness of a New Drug, Modified Release rhTSH, in Patients With Multinodular Goiter

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and effectiveness of 2 different doses of modified-release recombinant human thyroid stimulating hormone (MRrhTSH) when administered with radioiodine in patients with multinodular goiter, a condition that involves the enlargement of the thyroid gland. We will also evaluate the safety and effectiveness of radioiodine therapy alone in these patients. The goal of the treatment is to determine if there was a reduction in the size of the goiter and to study if goiter symptoms have improved after 6 months and after 36 months.

Conditions

• Multinodular Goiter

Interventions

Type	Name	Description
OTHER	Placebo	33 patients to placebo + 131-I arm
DRUG	MRrhTSH	33 patients to 0.01 mg MRrhTSH + 131-I arm
DRUG	MRrhTSH	33 patients to 0.03 mg MRrhTSH + 131-I arm

Timeline

• Start date: 2007-07-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2007-03-30
• Last updated: 2022-06-07

Locations

11 sites across 8 countries: United States, Brazil, Canada, Denmark, France, Germany, Italy, Netherlands