ESTUDIO AUXOGROWTH - Estudio Exploratorio para la Utilización del Programa de Crecimiento AuxoLog en Pacientes con Déficit de Hormona de Crecimiento tratados con Hormona de Crecimiento Recombinante Biosimilar

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/13146
• EU PAS number:
  EUPAS7654
• Study ID:
  13146
• Official title and acronym:
  ESTUDIO AUXOGROWTH - Estudio Exploratorio para la Utilización del Programa de Crecimiento AuxoLog en Pacientes con Déficit de Hormona de Crecimiento tratados con Hormona de Crecimiento Recombinante Biosimilar
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  The auxological parameters of GHD children treated with rhGH are compared with the countries specific growth standards and charts. Those are standardized and regular applied to all children in a unified manner, not attending to specific differences and allocation in differentiated growth groups.Nevertheless the development of children is not homogeneous and especially at the time of puberty, differences arise particularly in the age of pubertal onset, the time of pubertal growth spur and the rate of pubertal growth. Therefor the classification of children according to their pubertal group is of major importance, since children with a late or very late pubertal growth spur onset may be misdiagnosed as non-responders to rhGH and prematurely suspend their treatment, preventing them from reaching their full potential height.The Auxogrowth study intends to include the date of pubertal/post pubertal Spanish children treated with Omnitrope® on the AuxoLog program in order to evaluate their growth.It will include pubescent or post-pubescent children with GHD treated with Omnitrope® for at least two years before the onset of puberty with data available from at least one GH production stimulation test.Its objectives are to assess the increase in stature and growth rate in pubertal/post pubertal GHD children treated with Omnitrope® for a minimum of two years and to classify them according to time of pubertal development. The study will use the online AUXOLOG database program to conduct the work.AUXOLOG is a program that facilitates assessment of auxological parameters data and determination of growth patterns in children.
• Study status:
  Finalised

Research institutions and networks

Institutions

University Hospital Vall d’Hebron (HUVH)

Spain

Hospital Universitario Virgen del Rocío

Hospital Universitario Virgen del Rocío Seville, Spain, Hospital universitario Puerta del Mar Cádiz, Spain, Hospital San Pedro Logroño, Spain

Study timelines

Date when funding contract was signed

Planned: 17/03/2014

Actual: 17/03/2014

Study start date

Planned: 01/09/2014

Actual: 10/10/2014

Data analysis start date

Planned: 01/10/2015

Date of final study report

Planned: 01/04/2016

Actual: 14/04/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sandoz Farmacéutica

Study protocol

Initial protocol

Protocolo Auxogrowth v4

Regulatory

• Was the study required by a regulatory body?:
  No