IGF1 Generation Test (CAREL)

Pfizer logo

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)

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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