CompletedPhase 2

Safety, Tolerability and PK/PD Study in Young Adult Patients With Childhood Onset Growth Hormone Deficiency (GHD).

Hungary36 participantsStarted 2008-07

Plain-language summary

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

Who can participate

Age range18 Years – 30 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Temporal profiling of circulating IGF-1 levels.

Timeframe: 3 period

Trial details

NCT IDNCT00778518

SponsorAmbrx, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-10

View on ClinicalTrials.gov More Growth Hormone Deficiency trials