Evaluation of Overall Compliance and Duration of Zomacton® Treatment With the Zomajet® Needle-free Device (ZOMAJET)

Ferring

Status: Completed

Conditions: Turner's Syndrome; Human Growth Hormone Deficiency

Treatments: Drug: Somatropin

Study type: Observational

Funder types: Industry

Identifiers

NCT01306357

RZO 01

Details and patient eligibility

About

The purpose of this strictly observational, prospective, longitudinal study is to evaluate with sufficient precision the rate of overall treatment compliance from one year to 3 years of follow-up of the patients.

Somatotropin is indicated in the long-term treatment of children with growth retardation related to a deficiency in secretion of growth hormone and in the long-term treatment of growth retardation related to Turner's syndrome confirmed by chromosomal analysis. These are the two indications of Zomacton® 4 mg and 10 mg injection solution.

The use of the Zomajet® needle-free device (Zomajet® 2 Vision, reserved for the administration of Zomacton® 4 mg or of the Zomajet® Vision X needle-free device, reserved for the administration of Zomacton® 10 mg), allows the product to be administered by percutaneous transjection (needle-free) and can be used by the child directly or by the family after an initial training.

In April 2004, the CEPP (Commission for the Evaluation of Products and Services) requested a follow-up of the cohort of patients using the Zomajet® 2 Vision system measuring the compliance and duration of use of the device.

The number of patients initiated on Zomacton treatment using the Zomajet® needle-free device is estimated to 30. Over a period of inclusion of 3 years, we therefore estimate that 90 patients will be treated. In the cohort studied the patients will be followed-up for 1 year at least and for 3 years at the maximum.

The rate of treatment compliance will be evaluated according to the ratio of the actual duration of administration over the total duration recommended by the physician during the observation period.

Enrollment: 87 patients

Sex: All

Ages: 1 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Growth hormone deficiency
• Turner's syndrome

Exclusion criteria

• Patients who do not meet the criteria in the treatment Information Sheet

Trial design

87 participants in 1 patient group

Zomacton® with Zomajet® needle-free device

Description:

Zomacton® 4 mg delivered by percutaneous transjection (needle-free) using the Zomajet® 2 Vision device or Zomacton® 10 mg delivered by percutaneous transjection (needle-free) using the Zomajet® Vision X needle-free device.

Treatment:

Drug: Somatropin