Adult Growth Hormone Deficiency Clinical Trial
Official title:
A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate the Long-term Safety and Efficacy of Norditropin® Formulation in Patients With AGHD
Verified date | January 2015 |
Source | Novo Nordisk A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Pharmaceuticals and Medical Devices Agency |
Study type | Observational |
This study is conducted in Japan. The aim of this observational study is to collect information about the safety and efficacy of Norditropin® long-term treatment of growth hormone deficiency in adults.
Status | Completed |
Enrollment | 387 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Severe adult growth hormone deficiency Exclusion Criteria: - Known or suspected allergy to study product(s) or related products - Previous participation in the study - Diabetes Mellitus - Presence of malignant tumor(s) - Pregnant or likely to get pregnant |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Novo Nordisk A/S |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number and type of suspected serious adverse drug reactions (SADRs) during the study period | after 5 years | Yes | |
Secondary | Number of impaired glucose tolerance events during the study period | evaluated after 3 months, 6 months, 1 year and between 2-5 years | Yes | |
Secondary | Number of other types of adverse events (AEs) during the study period | evaluated after 3 months, 6 months, 1 year and between 2-5 years | Yes | |
Secondary | Effects on body composition (body fat percentage, lean body weight mass, bone density, bone mineral density) | evaluated after 3 months, 6 months, 1 year and between 2-5 years | No | |
Secondary | Effects of insulin-like growth factor-1 (IGF-I) levels | evaluated after 3 months, 6 months, 1 year and between 2-5 years | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02229851 -
Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.
|
Phase 3 | |
Completed |
NCT01562834 -
Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult Patients
|
Phase 4 | |
Completed |
NCT01822340 -
Safety and Efficacy Study of Recombinant Human Growth Hormone in Adult Growth Hormone Deficiency Patients
|
Phase 2 | |
Completed |
NCT01706783 -
A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone (Somapacitan) Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency
|
Phase 1 | |
Completed |
NCT00184730 -
Long-term Trial on Growth Hormone Deficiency in Adults (GHDA)
|
Phase 3 | |
Completed |
NCT00519558 -
Growth Hormone Deficiency in Adults (GHDA)
|
Phase 3 | |
Terminated |
NCT01698944 -
Cardiovascular Effects on Growth Hormone Therapy in Adults With Growth Hormone Deficiency
|
Phase 4 | |
Completed |
NCT03075644 -
A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency
|
Phase 3 | |
Completed |
NCT02005198 -
Assessing the Minimal Important Difference (MID) of the Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD)
|
N/A | |
Terminated |
NCT01909479 -
A Phase 3, Multicenter Study To Evaluate The Efficacy And Safety Of MOD-4023 In Adults With Growth Hormone Deficiency
|
Phase 3 | |
Completed |
NCT01806298 -
An Open-label Phase 4 Study to Explore Immunogenicity of the Liquid Formulation of Saizen® in Subjects With Adult Growth Hormone Deficiency (AGHD)
|
Phase 4 | |
Completed |
NCT03186495 -
Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function
|
Phase 1 | |
Recruiting |
NCT05979480 -
The Effects of Growth Hormone Treatment Discontinuation in Adults on Metabolic Profile, Body Composition and Quality Of Life (GAMBOL Study)
|
||
Completed |
NCT02526420 -
Versartis International Trial in Adults With Long-Acting Growth Hormone
|
Phase 2 | |
Completed |
NCT00934063 -
An Observational Study Validating a Score That Quantifies the Therapeutic Response to Treatment With Norditropin®
|
N/A | |
Completed |
NCT00715689 -
Dose Study in Growth Hormone Deficient Adults Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083
|
Phase 2 | |
Completed |
NCT00297713 -
Study of an Extended-Release, Crystalline Formulation of Recombinant Human Growth Hormone (ALTU-238) in Growth Hormone Deficient Adults to Determine Pharmacokinetics, Pharmacodynamics, and Drug Safety
|
Phase 2 | |
Completed |
NCT01543880 -
Safety and Efficacy of Long-term Somatropin Treatment in Adults
|
N/A | |
Completed |
NCT01580605 -
French National Registry of Adults With Growth Hormone Deficiency Treated With Somatropin
|
||
Not yet recruiting |
NCT04867317 -
Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
|
Phase 3 |