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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Multinod

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 Summary:
Sponsor: Genzyme, a Sanofi Company

Current Primary Outcome:

  • Change from baseline to 6 months in goiter size by computer tomography (CT) scan. [ Time Frame: Duration of core study ]
  • Extension Phase: Change in goiter size by CT scan at 36 months versus baseline, Months 6, 12 and 24 [ Time Frame: Duration of extension phase ]


Original Primary Outcome: Change from baseline to 6 months in goiter size by recent CT scan.

Current Secondary Outcome:

  • Change in goiter size from baseline to 6 months in smallest cross sectional area of the trachea (SCAT). [ Time Frame: Duration of core study ]
  • The percentage of patients in each group who attained a goiter volume shrinkage at 6 months of 28% or greater. [ Time Frame: Core Study ]
  • Extension Phase: Change in goiter size from baseline to 6, 12, 24 and 36 months by SCAT and neck ultrasound. [ Time Frame: Duration of extension phase ]
  • Thyroid Quality of Life Questionnaire [ Time Frame: Core Study and Extension Phase ]
  • Thyroid Stimulating Hormone (TSH), free thyroxine (FT4), total thyroxine (TT4), FT1, free triiodothyronine (FT3), total T3 (TT3). [ Time Frame: Core Study and Extension Phase ]
  • Physical Exams, Vitals, Adverse Events, Respiratory symptoms [ Time Frame: Core Study and Extension Phase ]
  • Routine labs, serial thyroid function tests, antibodies to MRrhTSH, antibodies against the thyroid stimulating hormone receptor, and physical exam. [ Time Frame: Core study and extension phase ]
  • Tracheal diameter measurements determined by ultrasound at Visit 3 compared to baseline measurement. [ Time Frame: core study - Visit 3 ]
  • Electrocardiogram (ECG) [ Time Frame: Duration of core study ]
  • Treatment-emergent hyperthyroidism (Hyperthyroid Symptom Scale (HSS) score ≥ 20). [ Time Frame: Core study ]


Original Secondary Outcome: Change from baseline to 6 months in smallest cross-sectional area of the trachea (SCAT).

Information By: Sanofi

Dates:
Date Received: March 28, 2007
Date Started: July 2007
Date Completion:
Last Updated: October 27, 2014
Last Verified: October 2014