Transition Study: Growth Hormone Therapy In Partial Growth Hormone Deficient Adolescents (TAUBER)

Pfizer

Status and phase: Completed; Phase 3

Conditions: Growth Hormone Deficiency

Treatments: Procedure: Radiography; Procedure: Blood sample

Study type: Interventional

Funder types: Industry

Identifiers

NCT00156143

A6281018

307-MET-9002-016

Details and patient eligibility

About

To evaluate in boys and girls the improvement in body composition under GH treatment in adolescents with CO-GHD who remain partially GHD after GH discontinuation.

Sex: All

Ages: 15 to 20 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or females : Chronological age > or = 15 years and < or = 20 years for females
• Chronological age > or = 17 years and < or = 20 years for males
• GHD of childhood onset treated for at least 2 years
• Last GH injection at least 12 months before baseline visit

Exclusion criteria

• Turner's syndrome
• Chronic hepatic impairment as shown by GGT and / or ASAT and / or ALAT > 2 X ULN

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)