Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00778518
Other study ID # PRO-ARX201-701
Secondary ID EudraCT: 2007-00
Status Completed
Phase Phase 2
First received October 22, 2008
Last updated October 9, 2009
Start date July 2008
Est. completion date October 2009

Study information

Verified date October 2009
Source Ambrx, Inc.
Contact n/a
Is FDA regulated No
Health authority Belarus: Ministry of HealthHungary: National Institute of PharmacyRomania: National Medicines AgencySerbia and Montenegro: Agency for Drugs and Medicinal DevicesUkraine: State Pharmacological Center - Ministry of Health
Study type Interventional

Clinical Trial Summary

Study to find the optimal dose of Growth Hormone Replacement in young adult patients suffering from childhood onset growth hormone deficiency (GHD).


Description:

The primary objective of this study is to evaluate the safety, tolerability and pharmacodynamic response of three different ARX201 doses (PEG-ahGH) when administered repeatedly to young adult patients with childhood onset growth hormone deficiency (GHD).


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date October 2009
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria:

- 18-30 years old

- GHD of childhood onset

- completed growth

- IGF-1 <=2SDS

- rhGH treatment naive

- hGH levels below cut-off

Exclusion Criteria:

- History of malignancy or intracranial tumors

- ECG abnormality

- ICH

- hepatic dysfunction

- renal impairment

- major medical conditions

- inadequate T4

- positive for HBV, HCV, or HIV

- alcohol or drug abuse

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Intervention

Drug:
ARX201
Reconstituted lyophilized drug product at 2.5 mg/wk; 3 periods over six months.
ARX201
Reconstituted lyophilized drug product at 5.0 mg/wk; 3 periods over six months.
ARX201
Reconstituted lyophilized drug product at 10.0 mg/wk; 3 periods over six months.

Locations

Country Name City State
Hungary Accelsiors CRO and Consultancy Services Budapest

Sponsors (2)

Lead Sponsor Collaborator
Ambrx, Inc. Merck Serono International SA

Country where clinical trial is conducted

Hungary, 

Outcome

Type Measure Description Time frame Safety issue
Primary Temporal profiling of circulating IGF-1 levels. 3 period Yes
Secondary Body composition measurements at start of study and end of study 6 months No
See also
  Status Clinical Trial Phase
Recruiting NCT02243852 - Effects of Growth Hormone (GH) Deficiency and Growth Hormone Replacement on Serum Fibroblast Growth Factor 21 (FGF21) N/A
Completed NCT01440686 - Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male Volunteers Phase 1
Completed NCT00990340 - Comparison of a Needle-free Injection Method With a Needle-syringe Injection Method Phase 4
Completed NCT00149708 - Consequence of Lifetime Isolated Growth Hormone Deficiency N/A
Completed NCT00235599 - The IGFBP-3 Stimulation Test: A New Tool for the Diagnosis of Growth Hormone Deficiency in Children. N/A
Completed NCT00459940 - The Effects of TZD on Fat Metabolism and Insulin Sensitivity in GH-Replaced GHD Patients N/A
Completed NCT01157793 - A Multicentre, Randomised, Open-label, Controlled Study to Evaluate the Effects of Saizen® on Cardiac Function in Growth Hormone Deficient(GHD) Subjects During the Transition Phase From Childhood to Adulthood Phase 4
Completed NCT00004365 - Study of Pituitary Size and Function in Familial Dwarfism of Sindh N/A
Recruiting NCT00227253 - Chromosome 18 Clinical Research Center
Recruiting NCT04121780 - Growth Hormone Replacement Therapy for Retried Professional Football Players Phase 2
Completed NCT02934399 - Dynamic Hormone Diagnostics in Endocrine Disease
Completed NCT01090778 - Diurnal Variation of Exogenous Peptides (GH Puls/Jurgita I) Phase 2
Completed NCT01062529 - Peripheral Metabolic Effects of Somatostatin N/A
Completed NCT00965484 - Genotropin Study Assessing Use of Injection Pen Phase 3
Completed NCT00616278 - National Cooperative Growth Study in CKD N/A
Completed NCT02693522 - Evaluation of Efficacy and Safety of Recombinant Somatroipn in Patients With Growth Hormone Deficiency Phase 3
Recruiting NCT02908958 - Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency Phase 4
Terminated NCT01243892 - A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device N/A
Withdrawn NCT00638287 - Inter-Assay Growth Hormone and IGF-I Variability N/A
Completed NCT00957671 - Anterior Pituitary Hormone Replacement in Traumatic Brain Injury Phase 4