Nodular 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. MedDRA version: 9.1 Level: LLT Classification code 10043808 Term: Thyrotropin
Conditions
Interventions
Trade Name: Thyrogen (thyrotropin alfa)
Product Code: MRrhTSH
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: thyrotropin alfa
Other descriptive name: modified release huma
Sponsors
Genzyme Europe BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to determine the dose-response and safety of 2 doses of 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): Primary endpoint: •Change from baseline to 6 months in goiter size by recent-generation CT scan. Secondary endpoints: •Change from baseline to 6 months in smallest cross-sectional area of the trachea (SCAT). •Change in 24 hour (h) and either 72 or 96 h radioiodine uptake from baseline to post-treatment. •Thyroid Quality of Life Questionnaire (ThyQoL). •TSH, free thyroxine (FT4), total thyroxine (T4), FTI, free T3, total T3. •The percentage of patients in each group that attained a goiter volume shrinkage at 6 months of 28% or greater. Safety Endpoints: •Routine labs, serial thyroid function tests, EKG, medical history, and physical exam. •Thyroid ultrasound and tracheal diameter measurements after treatment compared to initial measurement. •EKG findings (12 lead, 2 minute rhythm strip) in all patients. •Tachyarrhythmia Assessment (Directed Questions). •Respiratory Symptoms (Directed Questions). •AEs / Serious adverse events (SAEs). •Vital signs. •Treatment-emergent hyperthyroidism (HSS score = 20). | — |
Countries
Denmark, France, Germany, Italy, Netherlands
Outcome results
None listed