Phase 2 N=56 Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial
Heart Failure · Growth Hormone Deficiency · Ischemic Heart Disease
Primary: Peak VO2 — 14.5; 12.9 ml/kg/min
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=46 Growth Retardation In Children With Special Pathological Conditions Or Disease
Endocrine System Diseases
Primary: Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Intent-to-Treat (ITT) Population — -1.29; 2.36 SDS
Phase 3 N=11 Effects of Growth Hormone on Cognition and Cerebral Metabolism in Adults With Growth Hormone Deficiency
Hypopituitarism
Primary: BOLD Signal Measured by Functional MRI Scan to Functional Connectivity Measured by fMRI
Phase 3 N=136 Prepubertal Children With Growth Failure Associated With Primary Insulin-Like Growth Factor-1 (IGF-1) Deficiency
Growth Disorders · Insulin-Like Growth Factor-1 Deficiency
Primary: Height Velocity During the First Year - Intent to Treat (ITT)Population — 5.2; 6.9; 7.7 cm/yr — p=<0.0001
Phase 2 N=22 Growth Hormone Treatment in Patients With Aggrecan (ACAN) Deficiency
Short Stature
Primary: Height Standard Deviation Score — -2.52; -1.57; -1.19; -1.09 standard deviation score
Phase 3 N=146 A Safety, Tolerability and Efficacy Study of TransCon hGH in Children With Growth Hormone Deficiency
Growth Hormone Deficiency, Pediatric · Endocrine System Diseases · Hormone Deficiency
Primary: Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] — 83; 6; 1; 0 Participants
Phase 4 N=20 Endocrine Dysfunction and Growth Hormone Deficiency in Children With Optic Nerve Hypoplasia
Growth Hormone Deficiency · Septo-Optic Dysplasia · Hypopituitarism
Primary: Change in Anthropometric Measures Over Time — 1.97; -0.61; 1.39; 1.22 Z-score
Phase 3 N=44 Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone Deficiency
Growth Hormone Deficiency
Primary: Annual Height Velocity (HV) After 12 Months — 9.78; 7.78 cm/year
N/A N=25 Effects of Short-term Growth Hormone in HIV-infected Patients
HIV Lipodystrophy
Primary: Overnight Mean Growth Hormone Secretion After 2 Weeks of Study Drug — 0.23; 0.07; 1.24 ng/mL — p=0.01
Phase 3 N=43 Genotropin Treatment In Very Young Children Born Small For Gestational Age
Infant, Small for Gestational Age
Primary: Change From Baseline in Height Standard Deviation Score (SDS) at Month 24. — 1.63; 0.43 SDS — p=<0.001
Phase 4 N=82 A Post-Marketing Study of the Immunogenicity of Somatropin (Ribosomal Deoxyribo Nucleic Acid [rDNA] Origin) Injection (Nutropin AQ®) in Children With Growth Hormone Deficiency
Growth Hormone Deficiency
Primary: Percentage of Participants Who Develop Anti-GH Antibodies After Treatment With Nutropin AQ v1.1 — 3.7 percentage of participants
Phase 4 N=213 Predictive Markers in Chinese Growth Hormone Deficiency (GHD) Children Treated With Saizen®
Dwarfism, Pituitary
Primary: Change From Baseline in Serum Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) Levels at Week 4 — -2.04; -2.22; 1.38; 0.85 nanogram/millilter (ng/mL)…
N/A N=56 Physiologic Growth Hormone Effects in HIV Lipodystrophy
AIDS · HIV Infections
Primary: Change in Visceral Adipose Tissue Area From Baseline to 18 Months — -22; -4 centimeters squared — p=0.049
Phase 2 N=63 Recombinant Human Growth Hormone During Rehabilitation From Traumatic Brain Injury.
Traumatic Brain Injury
Primary: Functional Outcome 6 Months After Injury, as Measured by the Processing Speed Index — 82.5; 82.5 Processing speed index standardized scor
Phase 3 N=162 A Phase 3 Trial of the Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)
Growth Hormone Deficiency, Pediatric · hGH (Human Growth Hormone) · Endocrine System Diseases
Primary: Annualized Height Velocity at 52 Weeks for Weekly Lonapegsomatropin and Daily hGH Treatment Groups — 11.17; 10.31 cm/year — p=0.0088
Phase 3 N=42 Growth Hormone Therapy in Osteogenesis Imperfecta
Osteogenesis Imperfecta
Primary: Proportion of Subjects Who Met Criteria of Increase in Growth Rate Since Baseline. — 25 Participants
N/A N=377 A Prospective Non-Interventional Study Protocol With Primary Data Collection - Assessment Of The Long Term Treatment Outcomes Of Genotropin Treatment In Growth Hormone Deficiency (GHD) Patients
Growth Hormone Deficiency
Primary: Number of Participants Classified According to Insulin-like Growth Factor (IGF-I) Assessments — 11; 2; 4; 63 Participants
N/A N=230 Drug Use Investigation of Somatropin for GHD-ADULTS.
Dwarfism, Growth Hormone Deficiency
Primary: Number of Participants With Treatment Related Adverse Events. — 29 participants
Phase 3 N=98 Growth Hormone Treatment in Children Born Small for Gestational Age (SGA)
Foetal Growth Problem · Small for Gestational Age
Primary: Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 260 - Subjects Received NN220 Treatment for 5 Years — -2.9488; -2.9047; 1.2066; 2.0247…
Phase 3 N=113 Growth Hormone in Neuroendocrine Dysfunction With Severe Fibromyalgia Syndrome
Fibromyalgia
Primary: Percentage of Participants With Less Than 11 Tender Points at Month 6 — 20; 22 Percentage of participants
Phase 3 N=57 Study Aimed At Improving Height With Genotonorm In Children Born Little And/Or Light With Growth Retardation At The Age
Fetal Growth Retardation
Primary: Percentage of Children With Insulin Growth Factor-1 (IGF-1) > 2 Standard Deviation (SD) at 9 and 12 Months — 86.0; 14.0 percentage of participants
Phase 3 N=101 Investigation of a New, Oral Growth Hormone Secretagogue, AEZS-130 as a Growth Hormone Stimulation Test.
Diagnosis of Adult Growth Hormone Deficiency (AGDH)
Primary: Receiver Operating Characteristic (ROC) Analysis on Peak GH (Growth Hormon) Concentrations — 2.36; 17.71 ng/mL
Phase 3 N=298 A Long-Term Trial Investigating Safety and Efficacy of TransCon hGH in Children With Growth Hormone Deficiency Who Have Completed a Prior TransCon hGH Clinical Trial
Growth Hormone Deficiency, Pediatric · Endocrine System Diseases · Hormone Deficiency
Primary: Number of Subjects With Treatment-Emergent Adverse Events [Long-Term Safety and Tolerability] — 226 Participants
N/A N=43 The Glucagon Stimulation Test for Evaluation of Adult Growth Hormone Deficiency and Adrenocorticotropic Axis
Adult Growth Hormone Deficiency · Hypothalamic-pituitary Disorders
Primary: Peak GH Level in Adult Patients With Hypothalamic-pituitary Disorders and 1-2 Pituitary Hormone Deficiency (PHD). — 0.9; 0.6; 0.7 ng/mL
N/A N=77 Study of Growth Hormone and Bone in Obesity
Obesity · Osteopenia
Primary: Bone Mineral Density — -0.015; -0.008 grams/cm^2
Phase 2 N=53 Safety, PK/PD (Pharmacokinetics/Pharmacodynamics) and Efficacy of ACP-001 Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)
Growth Hormone Deficiency (GHD)
Primary: Incidence of Anti-hGH Binding Antibody Formation — 1; 0; 0; 0 participants
Phase 2 N=35 Testosterone and Growth Hormone for Bone Loss in Men
Hypopituitarism · Hypogonadism · Growth Hormone Deficiency
Primary: MicroMRI-derived Structural (Bone Volume Fraction-BVF) of the Distal Tibia at Baseline and After One and Two Years of Treatment. — 0.112; 0.104; 0.119; 0.111 unitless
Phase 3 N=92 Long-Term Treatment With rhIGF-1 in GHIS
Growth Hormone Insensitivity Syndrome
Primary: Annualized Height Velocity Up to 12 Years — 2.6; 8.0; 5.9; 5.5 centimeter per year (cm/y)
Phase 3 N=208 Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation
Growth Disorders · Intrauterine Growth Retardation
Primary: Change From Baseline in Annual Growth Rate Measured at 2 Years Following Treatment With Genotonorm — 3.07; 3.97; 2.84 cm/year — p=0.02922
Phase 3 N=45 Recombinant Human Insulin-Like Growth Factor (rhIGF-1) Treatment of Short Stature Associated With IGF-1 Deficiency
Insulin-Like Growth Factor-1 Deficiency · Growth Disorders
Primary: Height Velocity From Pretreatment (Week 0) to Week 34 — 7.0 centimeters per year (cm/yr)