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

This study is currently recruiting participants.
Verified by Genzyme, December 2007

Sponsored by: Genzyme
Information provided by: Genzyme
ClinicalTrials.gov Identifier: NCT00454220
  Purpose

The purpose of this study is to determine the safety and effectiveness of 2 different doses of modified release rhTSH 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.


Condition Intervention Phase
Multinodular Goiter
Other: Placebo
Drug: MRrhTSH
Phase II

Drug Information available for:   Thyroid    Thyrotropin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Genzyme:

Primary Outcome Measures:
  • Change from baseline to 6 months in goiter size by recent CT scan. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline to 6 months in SCAT. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Estimated Enrollment:   99
Study Start Date:   April 2007
Estimated Study Completion Date:   November 2008

Arms Assigned Interventions
A: Placebo Comparator
Placebo
Other: Placebo
placebo + 131-I
B: Experimental
Dose Group
Drug: MRrhTSH
0.01 mgMRrhTSH + 131-I
C: Experimental
Dose Group
Drug: MRrhTSH
0.03 mg MRrhTSH + 131-I

  Eligibility
Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • 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.
  • Potential patients need to be clinically free of thyroid cancer as determined by their health provider.
  • Women of childbearing potential must have a negative pregnancy test at Screening.
  • Routine blood laboratory values within normal range at Screening, as determined by central lab.
  • Committed to follow all protocol-required study procedures as evidenced by providing written informed consent within 14 days prior to Visit 1.

Exclusion Criteria:

  • Potential candidates that have a history of thyroid cancer, signs or symptoms of thyroid cancer, a history of head or neck irradiation, or a partial or near total thyroidectomy.
  • Within the past 45 days, use of propylthiouracil, methimazole or thyroxine, vitamins or supplements containing kelp or iodine, medications that significantly affect iodine handling such as high dose corticosteroids, high dose diuretics, or lithium.
  • Patient has currently or within the past 60 days used retinoic acid.
  • Use of amiodarone within the prior 2 years.
  • Received iodine-containing contrast agent within the past 3 months.
  • Patients with conditions in which use of beta-blockers are medically contraindicated, such as recently active asthma or clinically significant chronic obstructive pulmonary disease.
  • Within the past 5 years have a history of malignancy, other than squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix.
  • Prior MI, stroke within 6 months; atrial fibrillation or clinically significant arrhythmia within 6 months.
  • A concurrent major medical disorder (e.g., documented cardiac disease, debilitating cardiopulmonary disease, advanced renal failure, advanced liver disease, advanced pulmonary disease, or advanced cerebral vascular disorder) that may have an impact on the capability of the patient to adequately comply with the requirements of this study.
  • Women who are pregnant or lactating.
  • A recent history of alcoholism, drug abuse or other disorder that might affect compliance with the protocol.
  • Patients on anticoagulants except for aspirin.
  • Patients known to be human immunodeficiency virus (HIV) antibody positive or hepatitis B antigen positive.
  • Patients who have received 131I in the past, and have had a lifetime exposure of radioiodine.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454220

Contacts
Contact: Medical Information     800-745-4447     medinfo@genzyme.com    
Contact: Medical Information     617-252-7832     medinfo@genzyme.com    

Locations
United States, Massachusetts
Recruiting
      Boston, Massachusetts, United States
United States, Minnesota
Not yet recruiting
      Rochester, Minnesota, United States
United States, Ohio
Recruiting
      Columbus, Ohio, United States
Brazil
Not yet recruiting
      Curitiba, Brazil
Not yet recruiting
      Sao Paulo, Brazil
Not yet recruiting
      Rio de Janeiro, Brazil
Canada, Ontario
Recruiting
      London, Ontario, Canada
Denmark
Recruiting
      Odense, Denmark
France
Not yet recruiting
      Lille Cedex, France
Germany
Not yet recruiting
      Wurzburg, Germany
Italy
Not yet recruiting
      Sienna, Italy
Not yet recruiting
      Pisa, Italy
Netherlands
Recruiting
      Netherlands, Netherlands

Sponsors and Collaborators
Genzyme

Investigators
Study Director:     James Magner, MD     Genzyme    
  More Information


Responsible Party:   Genzyme ( Medical Monitor )
Study ID Numbers:   MRTSH01505
First Received:   March 28, 2007
Last Updated:   May 20, 2008
ClinicalTrials.gov Identifier:   NCT00454220
Health Authority:   United States: Food and Drug Administration;   Canada: Health Canada;   European Union: European Medicines Agency;   Brazil: National Health Surveillance Agency

Study placed in the following topic categories:
Goiter
Endocrine System Diseases
Endocrinopathy
Thyroid Diseases

ClinicalTrials.gov processed this record on October 21, 2008




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