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NCT03288103

Growth Hormone Treatment in Patients With Aggrecan (ACAN) Deficiency

Completed Phase 1, PHASE2 Results posted Last updated 30 July 2024
What this trial tests

Phase 1, PHASE2 trial testing Norditropin in Short Stature in 22 participants. Completed in 31 August 2023.

Timeline
1 February 2018
Primary endpoint
31 March 2023
31 August 2023

Quick facts

Lead sponsorChildren's Hospital Medical Center, Cincinnati
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment22
Start date1 February 2018
Primary completion31 March 2023
Estimated completion31 August 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Children's Hospital Medical Center, Cincinnati

Who can join

2 and older, any sex, with Short Stature. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Height Standard Deviation Score Primary · Annually through three years of treatment

Height Standard Deviation Score is the standard deviation above or below the mean the height is for age and gender. Values were obtained by plotting heights on Centers for Disease Control and Prevention growth charts. An increase in Height Standard Deviation Score correlates with increase in height. Results are reported for 10 patients treated with recombinant human growth hormone.

Baseline
GroupValue95% CI
Growth Hormone Treatment for Participants With ACAN Deficiency-2.52-4.27 – -1.07
Year 1
GroupValue95% CI
Growth Hormone Treatment for Participants With ACAN Deficiency-1.57-3.89 – -0.46
Year 2
GroupValue95% CI
Growth Hormone Treatment for Participants With ACAN Deficiency-1.19-3.55 – -0.08
Year 3
GroupValue95% CI
Growth Hormone Treatment for Participants With ACAN Deficiency-1.09-3.45 – -0.02
Height Velocity After Three Years of Treatment With Recombinant Human Growth Hormone (rhGH) Primary · Annually through three years of treatment

A participants calculated height velocity derived from height measurements taken over a period of 36 months (baseline visit to 36 month visit). Only those in the treatment arm were treated with growth hormone and observed for response.

Baseline
GroupValue95% CI
Growth Hormone Treatment for Participants With ACAN Deficiency5.23.8 – 7.1
Year 1
GroupValue95% CI
Growth Hormone Treatment for Participants With ACAN Deficiency8.37.3 – 11.2
Year 2
GroupValue95% CI
Growth Hormone Treatment for Participants With ACAN Deficiency7.75.9 – 8.8
Year 3
GroupValue95% CI
Growth Hormone Treatment for Participants With ACAN Deficiency6.84.9 – 7.2
Number of Participants With Clinical Features of ACAN Deficiency - Osteochondritis Dissecans Secondary · Baseline

Evidence of osteochondritis dissecans on MRI (in those who could cooperate to perform such unsedated between the ages of 6 years-old and 20 years-old) or radiograph examination of affected participant's knees.

GroupValue95% CI
Pediatric Phenotype Group3
Adult Phenotype Group1
Number of Participants With Clinical Features of ACAN Deficiency - Osteoarthritis Secondary · Baseline

Evidence of early joint pathology evident (osteoarthritis) on MRI (in those who could cooperate to perform such unsedated between the ages of 6 years-old and 20 years-old) or radiograph examination of affected participant's knees, performed in those who were age appropriate and would cooperate.

GroupValue95% CI
Pediatric Phenotype Group0
Adult Phenotype Group8

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected for treatment group participants from the time of enrollment until 3 months post treatment discontinuation. Adverse event data for phenotype participants was collected from time of enrollment until one week after the completion of their one-time study visit.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment Group
Serious: 0/10 (0%)
Deaths: 0/10
Phenotype Group
Serious: 0/12 (0%)
Deaths: 0/12
Other adverse events (34 terms — click to expand)

ReactionSystemTreatment GroupPhenotype Group
Knee PainMusculoskeletal and connective tissue disorders
HeadacheGeneral disorders
FeverInfections and infestations
Ankle PainMusculoskeletal and connective tissue disorders
ConjunctivitisEye disorders
Ear InfectionEar and labyrinth disorders
VomitingGeneral disorders
Sore ThroatEar and labyrinth disorders
Stomach pain/discomfortGastrointestinal disorders
Foot painMusculoskeletal and connective tissue disorders
Significant behavioral changesGeneral disorders
Hip painMusculoskeletal and connective tissue disorders
Injection site reaction (hives)Skin and subcutaneous tissue disorders
Face tinglingVascular disorders
Pes planusMusculoskeletal and connective tissue disorders
Injection site reaction (bruising)General disorders
ScoliosisMusculoskeletal and connective tissue disorders
COVID-19Infections and infestations
Dog bite on right earInjury, poisoning and procedural complications
Root CanalSurgical and medical procedures
Tooth ExtractionSurgical and medical procedures
BronchitisInfections and infestations
Lipohypertrophy of upper arms (bilateral)Skin and subcutaneous tissue disorders
Leg PainMusculoskeletal and connective tissue disorders
Contusion right legInjury, poisoning and procedural complications
Laceration above left eyeInjury, poisoning and procedural complications
PneumoniaRespiratory, thoracic and mediastinal disorders
Medication for injection was cloudyProduct Issues
Paronychia (big toe)Skin and subcutaneous tissue disorders
Vaginal Yeast InfectionInfections and infestations
Eyelid ErythemaEye disorders
Idiopathic UticariaSkin and subcutaneous tissue disorders
MolluscumSkin and subcutaneous tissue disorders
Right Knee Injury (Abnormal ACL)Injury, poisoning and procedural complications

Data from ClinicalTrials.gov NCT03288103 adverse events section.

Sponsor's own description

This is an open-label, single-arm prospective pilot study to study the effects of a single dose regimen of daily growth hormone medication (Norditropin) on pre-pubertal children with Aggrecan deficiency. The growth response will be tracked over a 12 month period. A protocol extension has been approved to continue subjects on treatment for an additional 2 years.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Treatment of Short Stature in Aggrecan-deficient Patients With Recombinant Human Growth Hormone: 1-Year Response.
    Muthuvel G, Dauber A, Alexandrou E, Tyzinski L, et al · · 2022 · cited 12× · PMID 34922359 · DOI 10.1210/clinem/dgab904
  2. Treatment of Short Stature in Aggrecan-deficient Patients With Recombinant Human GH: 3-year Response.
    Muthuvel G, Dauber A, Alexandrou E, Tyzinski L, et al · · 2024 · cited 3× · PMID 39502477 · DOI 10.1210/jendso/bvae177

Verify or expand the search:

Other trials of Norditropin

Trials testing the same drug.

Other recruiting trials for Short Stature

Currently open trials in the same condition.

Other Children's Hospital Medical Center, Cincinnati trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03288103.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing