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Clinical Trials/EUCTR2018-001989-42-DE
EUCTR2018-001989-42-DE
Active, not recruiting
Phase 1

Multicenter, open label trial to investigate the efficacy and safety of a single oral dose of 1.0 mg/kg macimorelin acetate as growth hormone stimulation test (GHST) in pediatric patients with suspected growth hormone deficiency (GHD) - the DETECT Trial

Aeterna Zentaris GmbH0 sites100 target enrollmentMay 7, 2021
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ConditionsDiagnosis of growth hormone deficiency in pediatric subjectsTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
DrugsMacimorelin Consilient HealthR-Gene 10Catapresan 75

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Diagnosis of growth hormone deficiency in pediatric subjects
Sponsor
Aeterna Zentaris GmbH
Enrollment
100
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 7, 2021
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Subjects are eligible to be included in the trial only if all of the following criteria apply:
  • •1\. Informed consent of subject, parent(s) or legally acceptable representative (LAR) of subject and child assent, if appropriate, must be obtained before any trial\-related activities. Trial\-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
  • •2\. Male and female pediatric subjects from 2 to less than 18 years of age at the time of signing informed consent.
  • •3\. Indication for the performance of growth hormone stimulation test.
  • •4\. Presence of a height measurement minimum 6 and maximum 18 months prior to screening.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 100
  • •F.1\.2 Adults (18\-64 years) no
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) no

Exclusion Criteria

  • •Subjects are excluded from the trial if any of the following criteria apply:
  • •Lack of suitability for the trial:
  • •1\. Established diagnosis of a disease that is sufficient to explain growth deficiency or metabolic disorders that are also associated with short stature (e.g., Turner syndrome, skeletal dysplasia’s, celiac disease, etc.).
  • •2\. Ongoing growth hormone therapy.
  • •3\. Presence of hypothyroidism and/or adrenal insufficiency without adequate and stable replacement therapy treatment for at least 30 days prior to first GHST.
  • •4\. Treatment with drugs directly affecting the pituitary secretion of somatotropin (e.g., somatostatin analogues, clonidine, levodopa and dopamine agonists) or provoking the release of somatostatin (antimuscarinic agents e.g., atropine).
  • •5\. Medical history of ongoing clinically symptomatic psychiatric disorders.
  • •6\. 2nd or 3rd degree atrioventricular\-block, prolongation of the QRS complex over 120 milliseconds, prolongation of the QTc interval over 450 milliseconds, or any
  • •other clinically significant abnormal electrocardiogram results at the screening
  • •ECG as judged by the investigator.

Outcomes

Primary Outcomes

Not specified

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