Safety, Tolerability and PK/PD Study in Young Adult Patients With Childhood Onset Growth Hormone Deficiency (GHD).
NCT ID: NCT00778518
Last Updated: 2009-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
36 participants
INTERVENTIONAL
2008-07-31
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
low dose
ARX201
Reconstituted lyophilized drug product at 2.5 mg/wk; 3 periods over six months.
2
Medium dose
ARX201
Reconstituted lyophilized drug product at 5.0 mg/wk; 3 periods over six months.
3
High Dose
ARX201
Reconstituted lyophilized drug product at 10.0 mg/wk; 3 periods over six months.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* GHD of childhood onset
* completed growth
* IGF-1 \<=2SDS
* rhGH treatment naive
* hGH levels below cut-off
Exclusion Criteria
* ECG abnormality
* ICH
* hepatic dysfunction
* renal impairment
* major medical conditions
* inadequate T4
* positive for HBV, HCV, or HIV
* alcohol or drug abuse
18 Years
30 Years
MALE
No
Sponsors
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Merck Serono International SA
INDUSTRY
Ambrx, Inc.
INDUSTRY
Responsible Party
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Clinical Research and Development, Ambrx, Inc.
Principal Investigators
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Mihaly Juhasz, MD
Role: STUDY_DIRECTOR
Accelsiors CRO & Consultancy Services
Locations
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Accelsiors CRO and Consultancy Services
Budapest, , Hungary
Countries
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Other Identifiers
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EudraCT: 2007-001746-40
Identifier Type: -
Identifier Source: secondary_id
PRO-ARX201-701
Identifier Type: -
Identifier Source: org_study_id
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