Effect of MAXOMAT ® on the Growth of Small Children to NOONAN's Syndrome

Sanofi

Status and phase: Completed; Phase 3

Conditions: Noonan Syndrome

Treatments: Drug: MAXOMAT ®, biosynthetic growth hormone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00452725

MAX08

Details and patient eligibility

About

1. Clinical Objective : To improve the growth of these children
2. Genetic objective : A study of the genetics of the syndrome

Enrollment: 36 patients

Sex: All

Ages: 3 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children and adolescents with Noonan's syndrome with a height < -2 SD and no progressive cardiopathy

Exclusion criteria

• Age < 3 years
• Height ≥ -2 SD

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)