IGF1 Generation Test (CAREL)

Pfizer

Status and phase: Completed; Phase 4

Conditions: Growth Hormone Deficiency

Treatments: Procedure: Blood sample; Procedure: Radiography

Study type: Interventional

Funder types: Industry

Identifiers

NCT00145457

A6281023

307-MET-9002-040

Details and patient eligibility

About

To assess the predictive value of the short term IGF-1 stimulation test, based on IGF-1 changes, on the 24 months growth response to 2 different doses of GH in patients with conventional GH deficiency.

Sex: All

Ages: 4 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female aged of more than 4 years.
• GHD defined as a peak GH level < 20 mUI/ml at two different pharmacological GH provocative tests including one done with two pharmacological agents and both performed within the year before the inclusion, according to the current recommendations of the French Health Authorities

Exclusion criteria

• Previous treatment with GH
• Ongoing pharmacological treatment with steroids except if corresponding to substitutive therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)