Adult Growth Hormone Deficiency Clinical Trial
Official title:
Dose Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC126-0083 in Growth Hormone Deficient Adults (GHDA)
Verified date | February 2017 |
Source | Novo Nordisk A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of NNC126-0083 in growth hormone deficient adults
Status | Completed |
Enrollment | 33 |
Est. completion date | March 2009 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility |
Inclusion Criteria: - GHDA subjects as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II - Fertile females must agree to use appropriate contraceptive methods and have a negative pregnancy test at inclusion - GH replacement therapy for more than 3 months - Body Mass Index (BMI, kg/m2) of 22.0 to 35.0 kg/m2, both inclusive Exclusion Criteria: - Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods - Malignant disease - Proliferative retinopathy judged by retina-photo within the last year - only with concomitant diabetes - Heart insufficiency, NYHA class greater than 2 - Subjects with diabetes with an HbA1C above 8.0% - Diabetic receiving insulin treatment - Stable pituitary replacement therapy for less than 3 months - Impaired liver function - Impaired kidney function |
Country | Name | City | State |
---|---|---|---|
Denmark | Novo Nordisk Investigational Site | Århus C | |
Denmark | Novo Nordisk Investigational Site | København Ø | |
Denmark | Novo Nordisk Investigational Site | Odense |
Lead Sponsor | Collaborator |
---|---|
Novo Nordisk A/S |
Denmark,
Søndergaard E, Klose M, Hansen M, Hansen BS, Andersen M, Feldt-Rasmussen U, Laursen T, Rasmussen MH, Christiansen JS. Pegylated long-acting human growth hormone possesses a promising once-weekly treatment profile, and multiple dosing is well tolerated in — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and tolerability (adverse events, local tolerability, physical examination) | 0 to 10 days after third dosing, (day 15-25 after first dose) | ||
Secondary | Cmax, maximum concentration of IGF-I | after trial product administration |
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 |
NCT01109017 -
Observational Study of the Safety and Efficacy of Norditropin® in Adult Patients With Growth Hormone Deficiency
|
N/A | |
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 |
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 |