At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 7 enrolled
Drug / intervention
Increlexdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Treatment With Recombinant Human Insulin-like Growth Factor 1 (rhIGF-1) in Patients With Pappalysin-2 (PAPP-A2) Gene Mutation.
Children's Hospital Medical Center, Cincinnati·interventional·Posted Dec 21, 2015·Updated Feb 28, 2024
In Brief
A Phase 2 clinical trial evaluating Increlex for Short Stature. Completed, enrolled 7 participants.
Detailed Summary
With this study we want to investigate the pharmacokinetic (PK) effect of a single injection of rhIGF-1 in patients with PAPP-A2 mutations compared to heterozygous carriers and healthy controls. This will be followed by treatment of PAPP-A2 deficient patients with IGF-1 for a period of one-year to assess growth velocity. Additionally, we want to further describe the phenotypic characteristics of patients with PAPP-A2 deficiency.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsShort Stature
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 2015
Enrollment StartDec 2015
Primary CompletionOct 2022
Study CompletionDec 2022
TodayJul 2026
First PostedDec 21, 2015
Enrollment StartDec 21, 2015
Primary CompletionOct 14, 2022
Study CompletionDec 1, 2022
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 10.5 years ago
Interventions
Increlexdrug
Treat PAPP-A2 deficient patients with Increlex