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Clinical Trials/EUCTR2018-004729-97-NL
EUCTR2018-004729-97-NL
Active, not recruiting
Phase 1

Randomized, controlled growth hormone study in children and adolescents with a Prader-Willi-like phenotype, followed by a two year open-label growth hormone study - effects on body composition, growth, psychosocial development and quality of life

Dutch Growth Research Foundation0 sites64 target enrollmentJune 6, 2019
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ConditionsPrader-Willi-like phenotypeMedDRA version: 20.0Level: LLTClassification code 10018747Term: Growth hormoneSystem Organ Class: 100000004848Therapeutic area: Diseases [C] - Hormonal diseases [C19]
DrugsGENOTROPIN (Somatropin)

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Prader-Willi-like phenotype
Sponsor
Dutch Growth Research Foundation
Enrollment
64
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 6, 2019
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Dutch Growth Research Foundation

Eligibility Criteria

Inclusion Criteria

  • •\- Prader\-Willi\-like phenotype, according to the PWL criteria (see below), or with a proven molecular diagnosis of a uniparental disomy of chromosome 14 (mUPD14\), or a mutation or duplication in the 15q11\.2\-q13 region (PWS\-critical region).
  • •\- Absence of a molecular diagnosis of PWS. This includes a type 1 (from breakpoint 1 to breakpoint 4\) or type 2 (from breakpoint 2 to breakpoint 4\) deletion, a uniparental disomy or imprinting center defect of the 15q11\.2\-q13 region.
  • •o Boys: 4 to 16 years
  • •o Girls: 4 to 14 years.
  • •\- Written informed consent.
  • •PWL criteria:
  • •The PWL phenotype is present in case of the following symptoms:
  • •Hyperphagia and/or rapid weight gain between the ages of 1 and 8 years
  • •Developmental/psychomotor delay (IQ\<85 and/or enrolment in a school for children with special needs)
  • •One or more of the following symptoms:

Exclusion Criteria

  • •\- Non\-cooperative behavior
  • •\- Extremely low dietary intake of less than the minimally required intake according to WHO
  • •\- Use of medication to reduce weight
  • •\- BMI \> \+4SD

Outcomes

Primary Outcomes

Not specified

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