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Last Updated: November 26, 2020

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CLINICAL TRIALS PROFILE FOR THYROTROPIN ALFA

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505(b)(2) Clinical Trials for Thyrotropin Alfa

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT00054756 Study of Thyrotropin-Releasing Hormone in Normal Volunteers and in Patients With Thyroid or Pituitary Abnormalities Suspended National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 2 2003-02-01 This study will determine the safety and activity of a new formulation of thyrotropin-releasing hormone (TRH), a drug used for diagnosing and evaluating patients with certain thyroid gland abnormalities. Normal thyroid gland function depends on proper chemical signaling between the thyroid gland, the hypothalamus (the part of the brain where TRH is made), and the pituitary (another part of the brain). The TRH test helps assess this interaction. Production of the only FDA-approved preparation of TRH was stopped in July 2002. As a result, to have a continuous source of TRH available for NIH clinical and research purposes, the NIH Clinical Center (CC) Pharmacy Department produced a pharmaceutical grade formulation of TRH for patient use. This study will test the CC formulation in healthy volunteers to show that its activity and side effects are similar to those of the previously available commercial test preparation. It will then be studied in CC patients for whom the diagnostic test is recommended. Healthy volunteers between 18 and 65 years of age and all patients requiring TRH evaluation of hypothalamic-pituitary-thyroid gland interaction may be eligible for this study. Patients include those with pituitary reserve, inconsistent thyroid function test, inappropriate TSH secretion, or pre- and post-operative evaluation of pituitary tumors. Normal volunteers will be screened with a medical history, physical examination, and blood tests. Women of child-bearing potential will be given a pregnancy test; pregnant and breast-feeding women may not participate. The TRH test procedure will be the same for healthy volunteers and patients. All participants fast from midnight before the morning of the test. In the morning, a catheter (flexible plastic tube) is inserted into an arm vein for easy injection of the TRH and collection of blood samples. Blood pressure is monitored before and during the test. A blood sample is drawn, and then TRH is given through the catheter over a 1-minute period. Another nine blood samples are collected over a 3-hour period from the time of the TRH injection for measuring levels of various hormones. A total of less than 4 tablespoons of blood is taken for the test.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Thyrotropin Alfa

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00004778 Phase III Randomized, Double-Blind, Placebo-Controlled Study of Antenatal Thyrotropin-Releasing Hormone in Pregnant Women With Threatened Premature Delivery Completed Children's Hospital of Philadelphia Phase 3 1993-08-01 OBJECTIVES: I. Evaluate the effect of thyrotropin-releasing hormone (TRH) on the severity of initial lung disease and occurrence of chronic lung disease when given antenatally to women with threatened premature delivery. II. Evaluate possible mechanisms for the effects of TRH on the severity and incidence of chronic lung disease. III. Investigate whether a deficiency in endogenous cortisol and/or thyroid hormones after birth influences the severity of lung disease and the development of chronic lung disease.
NCT00004778 Phase III Randomized, Double-Blind, Placebo-Controlled Study of Antenatal Thyrotropin-Releasing Hormone in Pregnant Women With Threatened Premature Delivery Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 3 1993-08-01 OBJECTIVES: I. Evaluate the effect of thyrotropin-releasing hormone (TRH) on the severity of initial lung disease and occurrence of chronic lung disease when given antenatally to women with threatened premature delivery. II. Evaluate possible mechanisms for the effects of TRH on the severity and incidence of chronic lung disease. III. Investigate whether a deficiency in endogenous cortisol and/or thyroid hormones after birth influences the severity of lung disease and the development of chronic lung disease.
NCT00004778 Phase III Randomized, Double-Blind, Placebo-Controlled Study of Antenatal Thyrotropin-Releasing Hormone in Pregnant Women With Threatened Premature Delivery Completed National Center for Research Resources (NCRR) Phase 3 1993-08-01 OBJECTIVES: I. Evaluate the effect of thyrotropin-releasing hormone (TRH) on the severity of initial lung disease and occurrence of chronic lung disease when given antenatally to women with threatened premature delivery. II. Evaluate possible mechanisms for the effects of TRH on the severity and incidence of chronic lung disease. III. Investigate whether a deficiency in endogenous cortisol and/or thyroid hormones after birth influences the severity of lung disease and the development of chronic lung disease.
NCT00004840 Study of Antenatal Thyrotropin-Releasing Hormone in Women in Premature Labor to Prevent Lung Disease in Preterm Infants Completed Children's Hospital of Philadelphia N/A 1998-05-01 OBJECTIVES: I. Assess the efficacy and safety of antenatal administration of thyrotropin-releasing hormone to women in premature labor to improve pulmonary outcomes in preterm infants.
NCT00004840 Study of Antenatal Thyrotropin-Releasing Hormone in Women in Premature Labor to Prevent Lung Disease in Preterm Infants Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) N/A 1998-05-01 OBJECTIVES: I. Assess the efficacy and safety of antenatal administration of thyrotropin-releasing hormone to women in premature labor to improve pulmonary outcomes in preterm infants.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Thyrotropin Alfa

Condition Name

Condition Name for Thyrotropin Alfa
Intervention Trials
Hypothyroidism 2
Subclinical Hypothyroidism 2
Thyroid Disease 2
Respiratory Distress Syndrome 2
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Condition MeSH

Condition MeSH for Thyrotropin Alfa
Intervention Trials
Thyroid Diseases 8
Hypothyroidism 4
Thyroid Neoplasms 4
Graves Ophthalmopathy 3
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Clinical Trial Locations for Thyrotropin Alfa

Trials by Country

Trials by Country for Thyrotropin Alfa
Location Trials
United States 13
Denmark 4
France 2
United Kingdom 1
Taiwan 1
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Trials by US State

Trials by US State for Thyrotropin Alfa
Location Trials
Maryland 5
Texas 2
Connecticut 1
Minnesota 1
Ohio 1
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Clinical Trial Progress for Thyrotropin Alfa

Clinical Trial Phase

Clinical Trial Phase for Thyrotropin Alfa
Clinical Trial Phase Trials
Phase 4 4
Phase 3 2
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Thyrotropin Alfa
Clinical Trial Phase Trials
Completed 15
Recruiting 3
Not yet recruiting 3
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Clinical Trial Sponsors for Thyrotropin Alfa

Sponsor Name

Sponsor Name for Thyrotropin Alfa
Sponsor Trials
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 7
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 2
Children's Hospital of Philadelphia 2
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Sponsor Type

Sponsor Type for Thyrotropin Alfa
Sponsor Trials
Other 27
NIH 14
Industry 2
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