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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
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