Health TrialsbyHealthPanel

Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children

ConditionsGrowth DisordersGrowth FailureGrowth Hormone TreatmentGrowth
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age5-15
SponsorNorthwell Health

About this trial

A prospective, randomized, open-label single-blinded study of 50 subjects with growth hormone deficiency, ages 5 to 15 years in which 25 subjects will initiate rhGH therapy at 0.3mg/kg/week and the remaining 25 subjects will initiate their rhGH treatment at 0.2 mg/kg/week for the first 12 months of treatment. Safety parameters, height velocity, and adult height prediction by bone age determination will be assessed at 4-month intervals for 1 year following the initiation of rhGH therapy.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

Male or female, aged 5-15 years

In good general health as evidenced by medical history or diagnosed with growth hormone deficiency

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Somatropin

    Drug

    The treatment of children with subcutaneous recombinant human growth hormone (rhGH) is the current gold standard of care for children with diagnosed GHD. This study will serve only to investigate the optimal dose of treatment in the first year of treatment with rhGH.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Arm 1: Growth hormone 0.2 mg/kg/weekActive comparator 1 intervention
Group B: Arm 2: Growth hormone 0.3 mg/kg/weekActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Annualized Growth Velocity (GV) in the first year after treatment

Height (cm) at 0- month visit; height (cm) at 12-month visit

Time frame
I year

Secondary outcomes

1

IGF1- 0,4,8,12 months

IGF-1 will be collected at timepoints - 0,4,8,12 months

Time frame
12 Months
2

IGFBP3 - 0,4,8,12 months

IGFBP3 will be collected at timepoints - 0,4,8,12 months

Time frame
12 Months
3

HbA1c - 4,8,12 months

HbA1c will be collected at timepoints 4,8,12 months

Time frame
12 Months
4

Total T4 or Free T4 - 0,12 months

Total T4 or Free T4 will be collected at timepoints 0,12 months

Time frame
12 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwell Health

Lead sponsor

Source ClinicalTrials.gov
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