Skip to content

The Growth Hormone Deficiency Reversal Trial: Effect on final height of discontinuation vs continuation of growth hormone treatment in pubertal children with isolated growth hormone deficiency – A non-inferiority randomised controlled trial

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502008-62-00
Acronym
NIHR127468
Enrollment
40
Registered
2023-03-20
Start date
2023-05-17
Completion date
2024-12-04
Last updated
2023-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth Hormone Deficiency (GHD)

Brief summary

Final Height in Standard Deviation Score (FH SDS)

Detailed description

Growth Related: The proportion of children reaching normal adult height (- 2SD) The proportion reaching mid-parental Target Height (- 2SD) Difference in child's Target Height minus Final Height (in Standard Deviation Score and centimetres) Bone Related: Bone age delay at Final Height Bone age acceleration between enrolment and Final Height Bone health index at Final Height Biochemistry: Serum IGF-1 and lipid profiles (fasting lipids - serum triglyceride and total serum cholesterol) at Final Heig

Interventions

DRUGNutropinAq 10 mg/2 ml (30 IU) solution for injection.
DRUGSaizen 8 mg/ml Injektionslösung in einer Patrone
DRUGOmnitrope 5 mg/1.5 ml solution for injection in cartridge
DRUGHUMATROPE 6 mg - Pulver und Lösungsmittel zur Herstellung einer Injektionslösung
DRUGNorditropin FlexPro 15 mg/1
DRUG5 ml Injektionslösung in einem Fertigpen
DRUGGenotropin® MiniQuick 0
DRUG2 mg - Pulver und Lösungsmittel zur Herstellung einer Injektionslösung

Sponsors

University College London
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Final Height in Standard Deviation Score (FH SDS)

Secondary

MeasureTime frame
Growth Related: The proportion of children reaching normal adult height (- 2SD) The proportion reaching mid-parental Target Height (- 2SD) Difference in child's Target Height minus Final Height (in Standard Deviation Score and centimetres) Bone Related: Bone age delay at Final Height Bone age acceleration between enrolment and Final Height Bone health index at Final Height Biochemistry: Serum IGF-1 and lipid profiles (fasting lipids - serum triglyceride and total serum cholesterol) at Final Heig

Countries

Austria

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026