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Last Updated: February 25, 2024

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 Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 2 2003-02-07 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.
NCT00005905 ↗ Leptin to Treat Lipodystrophy Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 2 2000-06-01 This study will evaluate the safety and effectiveness of the leptin replacement therapy in treating lipoatrophy or lipodystrophy-a condition in which there is a total or partial loss of fat cells. Patients with lipodystrophy lack sufficient leptin, because this hormone is produced by fat cells. The leptin deficiency usually causes high blood lipid (fat) levels and insulin resistance that may lead to diabetes. Patients may have hormone imbalances, fertility problems, uncontrolled appetite, and liver disease due to fat accumulation. Patients 15 years and older with lipodystrophy are eligible for this study. Candidates are screened with a medical history and physical examination, and fasting blood tests. Those enrolled undergo the following additional procedures: - Ultrasound of the liver and, if abnormalities are found, possibly a liver biopsy - Resting metabolic rate measurement - measures the amount of oxygen breathed at rest in order to calculate how many calories are required to maintain resting body functions - Magnetic resonance imaging of the liver and other organs, and of muscle and fat - Estimation of body fat - measurements of height, weight, hip size, and skin folds over the arms and abdomen to estimate body fat content - Insulin tolerance test - measures blood glucose levels after administration of insulin. Insulin is given through an intravenous (IV) catheter (a thin tube placed in a vein) and blood is drawn 5 minutes before the test begins, when the test begins, and 5, 10, 15, 20 and 30 minutes into the test - Oral glucose tolerance test - measures blood glucose and insulin levels after drinking a glucose (sugar) solution. Blood samples are drawn through an IV catheter 15 minutes before the test begins, at the time the test begins, and 30, 60, 90 and 180 minutes into the test - Intravenous glucose tolerance test - measures tissue response to insulin and glucose after glucose is injected into a vein. The glucose injection is followed by a short infusion of insulin and then blood samples are taken over 3 hours to measure insulin and glucose levels - Appetite level and food intake - measures hunger level and caloric intake. Patients are questioned about their hunger level, given a variety of foods they may choose to eat and questioned again at various intervals about hunger level. On another day, patients are given breakfast (usually a milkshake) and when they want to eat again, the appetite level and caloric intake study is repeated. - Hormone function tests - the function of three hormones influenced by leptin (corticotropin-releasing hormone, thyrotropin-releasing hormone and luteinizing hormone-releasing hormone) are assessed. The hormones are injected intravenously and then blood samples are drawn. When all the tests are completed, leptin therapy begins. The drug is injected under the skin twice a day for 4 months by the patient or a caregiver (similar to self-administered insulin injections for diabetes). Blood is drawn once a month to monitor the effects of treatment and drug side effects. At clinic visits scheduled 1, 2 and 4 months after therapy starts, patients have a physical examination and meet with a dietitian. Medication dosage is also increased at these visits. At the end of 4 months, all baseline studies described above are repeated. Throughout the study, all patients complete a form once a week, in which they record their symptoms. Patients with diabetes also measure their blood glucose levels at home before each meal and at bedtime.
NCT00027456 ↗ Leptin to Treat Severe Insulin Resistance - Pilot Study Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 2 2001-11-01 This pilot study will evaluate the safety and effectiveness of leptin therapy in two children with severe insulin resistance syndrome. Patients with this condition often have high blood sugar levels and may have hormone imbalances, a constant feeling of warmth, fertility problems, large appetite, and enlarged liver due to fat accumulation. Leptin is a hormone produced by fat cells. It influences appetite, affects levels of reproductive hormones, and possibly manages how the body reacts to insufficient food. Certain people with severe insulin resistance syndromes have decreased amounts of fat tissue and make little or no leptin. A 13-year-old male and an 11-year-old female with severe insulin resistance will participate in this study. They will have the following tests and procedures before beginning 4 months of leptin therapy: - Insulin tolerance test - measures blood sugar levels after intravenous (IV) administration of insulin. Blood samples are collected through the IV tube at various intervals during the 1-hour test. - Ultrasound of the liver and, if abnormalities are found, possibly liver biopsies. - Fasting blood tests - to measure blood count, blood lipids, and various hormones and assess liver function. - Resting metabolic rate - to measure the amount of oxygen breathed at rest in order to calculate how many calories are required to maintain resting body functions. - Magnetic resonance imaging of the liver and other organs, and of muscle and fat. - Pelvic ultrasound in female patient - to detect ovarian cysts. - Estimation of body fat - measurements of height, weight, waist, hip size, and skin folds over the arms and abdomen to estimate body fat content. - Oral glucose tolerance test - measures blood sugar and insulin levels. The patient drinks a very sweet drink containing glucose (sugar), after which blood samples are collected through an IV tube in an arm vein at various intervals during the 3-hour test. - Intravenous glucose tolerance test - measures tissue response to insulin and glucose after glucose injection and insulin infusion. Blood is collected over 3 hours to measure insulin and glucose levels. - Appetite level and food intake - to measure hunger level and caloric intake. Patients are questioned about their hunger level, given a variety of foods they may choose to eat and questioned again at various intervals about hunger level. On another day, patients are given breakfast (usually a milkshake) and when they want to eat again, the appetite level and caloric intake study is repeated. - Hormone function tests - the function of three hormones influenced by leptin (corticotropin-releasing hormone, thyrotropin-releasing hormone and luteinizing hormone-releasing hormone) are assessed. The hormones are injected intravenously and then blood samples are drawn. - Questionnaire - patients complete a questionnaire about their activities and how they feel. - 24-hour urine collections - to measure specific hormones, proteins and sugars excreted in the urine. When the above tests are completed, leptin therapy will start. The drug is injected under the skin twice a day for 4 months. Patients will record their symptoms weekly throughout the study. Those with diabetes will measure their blood glucose levels daily before each meal and at bedtime. Follow-up visits at 1, 2 and 4 months after therapy will include a physical examination, blood tests and a meeting with a dietitian. At the 4-month visit, the tests done at the beginning of the study will be repeated.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Thyrotropin Alfa

Condition Name

Condition Name for Thyrotropin Alfa
Intervention Trials
Thyroid Cancer 3
Hypothyroidism 2
Respiratory Distress Syndrome 2
Thyroid Disease 2
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Condition MeSH

Condition MeSH for Thyrotropin Alfa
Intervention Trials
Thyroid Diseases 9
Thyroid Neoplasms 5
Hypothyroidism 4
Graves Disease 3
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Clinical Trial Locations for Thyrotropin Alfa

Trials by Country

Trials by Country for Thyrotropin Alfa
Location Trials
United States 17
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
California 2
Connecticut 1
Minnesota 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 18
Unknown status 3
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
Children's Hospital of Philadelphia 2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 2
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Sponsor Type

Sponsor Type for Thyrotropin Alfa
Sponsor Trials
Other 28
NIH 14
Industry 4
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