Clinical trial • Phase III • Endocrinology

somatropin for Short predicted height

Phase III trial of somatropin for Short predicted height.

Overview

Trial Therapeutic Area
Endocrinology
Trial Disease
Short predicted height
Trial Stage
Phase III
Drug Modality
Peptide/protein/enzyme|Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
10-12-2024
First CTIS Authorization Date
10-01-2025

Trial design

Omnitrope 10 mg/1.5 ml solution for injection in cartridge (somatropin) — Comparator; route: SUBCUTANEOUS INJECTION; dose unit: µg/Kg; max daily dose amount: 50 (µg/Kg). Letrozole Fair-Med Healthcare 2.5 mg film coated tablets (letrozole) — Test product; route: ORAL; max daily dose amount: 1.25 mg.-controlled Phase III trial across 1 site in Belgium.

Comparator
Omnitrope 10 mg/1.5 ml solution for injection in cartridge (somatropin) — Comparator; route: SUBCUTANEOUS INJECTION; dose unit: µg/Kg; max daily dose amount: 50 (µg/Kg). Letrozole Fair-Med Healthcare 2.5 mg film coated tablets (letrozole) — Test product; route: ORAL; max daily dose amount: 1.25 mg.
Target Sample Size
50
Trial Duration For Participant
1460

Eligibility

Recruits 50 paediatric patients.

Vulnerable Population
Participants are paediatric (boys with bone age 11–13 years). Informed consent is required. Subject information and informed consent form documents are provided for child and parents (L1_SIS and ICF Child and L1_SIS and ICF Parents) in Dutch (DU) and French (FR). The trial form indicates isVulnerablePopulationSelected=false but specific child and parent ICFs are supplied.

Inclusion criteria

  • {"criterion_text":"- Male gender"}
  • {"criterion_text":"- Adult height prediction below or equal to –2.5 SD : < 164.0 cm based on the Vlaamse groeicurve 2004 (vub.ac.be/groeicurven) using the Greulich and Pyle Bayley Pinneau prediction method"}
  • {"criterion_text":"- Pubertal: at least 4 ml of testicular volume for boys"}
  • {"criterion_text":"- Bone age ≥ 11 but ≤ 13 years for boys"}
  • {"criterion_text":"- Signed informed consent"}

Exclusion criteria

  • {"criterion_text":"- Children for whom data on birth length, weight and height of one of the parents are lacking"}
  • {"criterion_text":"- Sex steroid therapy"}
  • {"criterion_text":"- Diabetes mellitus"}
  • {"criterion_text":"- Renal insufficiency (serum creatinine > 1.5 mg/dl)"}
  • {"criterion_text":"- Hepatic disease ( liver test > 4 fold upper limit of normality)"}
  • {"criterion_text":"- Current congestive heart failure"}
  • {"criterion_text":"- Inability to follow the study protocol"}
  • {"criterion_text":"- Treatment with a non-registered drug during the last 90 days before the moment of inclusion."}
  • {"criterion_text":"- Bone dysplasia or sitting height/ total height > 2 SDS on standards by Gerver et al (see appendix)"}
  • {"criterion_text":"- Vertebral anomalies"}
  • {"criterion_text":"- Chronic use of glucocorticoids"}
  • {"criterion_text":"- Previous growth promoting therapy such as GH, sex steroids, oxandrolone, aromatase inhibitors"}
  • {"criterion_text":"- Known GH deficiency"}
  • {"criterion_text":"- Chronic infectious disease"}
  • {"criterion_text":"- Active rheumatic disease"}
  • {"criterion_text":"- Previously diagnosed or currently suspected malignancy"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Adult height gain = Final height minus predicted adult height","definition_or_measurement_approach":"Calculated as final (attained) height minus predicted adult height (i.e. formula provided in endpoint text)."}

Recruitment

Planned Sample Size
50
Recruitment Window Months
161
Consent Approach
Signed informed consent is required. Subject information and ICF documents exist for children (L1_SIS and ICF Child) and for parents (L1_SIS and ICF Parents) in Dutch (DU) and French (FR).

Geography

Total Number Of Sites
1
Total Number Of Participants
50

Belgium

Earliest CTIS Part Ii Submission Date
23-12-2024
Latest Decision Or Authorization Date
10-01-2025
Processing Time Days
18
Number Of Sites
1
Number Of Participants
50

Sites

Site Name
Universitair Ziekenhuis Antwerpen
Department Name
Pediatrics
Contact Person Name
Hilde Dotremont
Number Of Participants
50

Sponsor

Primary sponsor

Full Name
Universitair Ziekenhuis Antwerpen
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Belgium

Third parties

  • {"country":"Belgium","full_name":"Universitair Ziekenhuis Antwerpen","duties_or_roles":"study department","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
Omnitrope 10 mg/1.5 ml solution for injection in cartridge
Active Substance
somatropin
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Authorisation Status
Authorised
Maximum Dose
50 µg/Kg per day
Investigational Product Name
Letrozole Fair-Med Healthcare 2.5 mg film coated tablets
Active Substance
letrozole
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised
Maximum Dose
1.25 mg per day
Combination Treatment
Yes

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