Study to Define Optimal IGF-1 Monitoring in Children Treated With NutropinAq (OPTIMA)

Ipsen

Status and phase: Completed; Phase 3

Conditions: Pituitary Diseases; Turner Syndrome; Dwarfism; Renal Insufficiency, Chronic

Treatments: Drug: Somatropin (rDNA origin)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00234533

2004-000356-17 (EudraCT Number)

2-79-58035-700

Details and patient eligibility

About

The main purpose of this study is to establish an optimal monitoring regimen in NutropinAq treated children, using newly developed capillary blood spot IGF-1 measurement technology.

Enrollment: 251 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children under 18 with growth failure associated with inadequate growth hormone secretion, or Turner syndrome or chronic renal insufficiency.

Exclusion criteria

• Children with closed epiphyses
• Children with active neoplasm
• Children with acute critical illness

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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251 participants in 1 patient group

NutropinAq 10 mg/2 mL (30 IU)

Experimental group

Description:

Patients received daily subcutaneous (s.c.) injections of NutropinAq 10 milligrams (mg)/2 milliliters (mL) for 6 months. The therapeutic daily doses administered were as follows: * GHD patients: 0.025 - 0.035 mg/ kilogram (kg) bodyweight * TS patients: up to 0.05 mg/kg bodyweight * CRI patients: up to 0.05 mg/kg bodyweight Patients visited the study clinic for a baseline visit and for 2 other visits every 3 months (Weeks 12 and 24). Additional home assessments were made at Weeks 21, 22 and 23. The investigator determined the dose administered to each patient, and it was recommended to perform the injection in the evening.

Treatment:

Drug: Somatropin (rDNA origin)