Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00454220
Status:
COMPLETED
Last Update Posted:
2022-06-07
First Post:
2007-03-28
Brief Title:
Study to Determine the Dose the Safety and Effectiveness of a New Drug Modified Release rhTSH in Patients With Multinodular Goiter
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
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
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None