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Somatropin

Phase 3

Growth Hormone Deficiency | Small molecule | Endocrine |Pfizer, Inc.|Last Updated: Feb 21, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials2
Total Enrollment112
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00163189Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By GenotonormPHASE3 COMPLETED 98 — — Jan 1, 2005Dec 1, 2014Feb 21, 202419 France
NCT00174278Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature SecondaryPHASE3 COMPLETED 14 — — Feb 1, 1997Oct 1, 2006Aug 5, 20081 France
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Study Endpoints
Primary Endpoints
Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36: Full Analysis Population
Baseline, Month 36

Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement-Date of birth)/365.25\*12.

Change From Baseline in Height Standard Deviation Score (SD) for Chronological Age (CA) at Month 36: Per Protocol (PP) Population
Baseline, Month 36

Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement-Date of birth)/365.25\*12.

The main efficacy variable is the height SDS (SEMPE) before and after treatment.
The standing height of the patients is measured during the inclusion visit and at each follow-up visit.
The height measurements are always performed at the same time of the day by
use of a wallmounted device (e.g. Harpenden Stadiometer).
Each child has to be measured three times, the mean of these measurements is recorded in the Case Report Form as the present height.
The body weight is measured by use of a balance scale.
Puberty stage is assessed (according to Tanner´s cotation) at the same visits as height is measured.
Secondary Endpoints
Mean Height
Baseline, Month 12, 24, 36, 48, 60
Mean Height Standard Deviation Score (SDS) for Bone Age (BA)
Baseline, Month 12, 24, 36, 48, 60
Annual Growth Rate (AGR)
Baseline, Month 12, 24, 36, 48, 60
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SomatropinEXPERIMENTAL -
Interventions
NameTypeDescription
SomatropinDRUGLiquid, daily, during 3 years and extended to 5 years Dosage: 0,46 mg/kg/week - the maximum dose should not exceed 50 µg/kg/day
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Eligibility Criteria
Age Range6 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * Glucocorticosteroid treatment for 12 months at least * Bone age \< 15 years for a boy and \< 13 years for a girl * Child measured height \< - 2 SD, Child currently treated by GH Exclusion Criteria: * Known diabetes (type 1 or type 2) * A previous history of intolerance or hy...

Countries:France
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