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 - ND
- Conditions
- Multinodular goiterMedDRA version: 6.1Level: PTClassification code 10018498
- Registration Number
- EUCTR2005-004451-35-IT
- Lead Sponsor
- Genzyme Europe BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 99
1. Adults aged 40 ? 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 110 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 signing informed consent 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) no
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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the dose-response and safety of 2 doses of modified-release rhTSH (MRrhTSH) with radioiodine (131I) therapy to achieve goiter shrinkage and improve goiter symptoms compared with 131I therapy alone in an adult population with small to moderate-sized multinodular goiter.;Secondary Objective: Reduction of goiter by 28% volume shrinkage;Primary end point(s): Change from baseline to 6 months in goiter size by recent-generation CT scan.
- Secondary Outcome Measures
Name Time Method