At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 48 enrolled
Drug / intervention
MOD-4023drug
Likely dose
MOD-4023 50 mgfrom 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.
Safety and Dose Finding Study of Different MOD-4023 Dose Levels Compared to Daily R-human Growth Hormone (hGH) Therapy in Pre-pubertal Growth Hormone Deficient Children
In Brief
A Phase 2 clinical trial evaluating MOD-4023 for Growth Hormone Deficiency (GHD). Completed, enrolled 48 participants across 13 sites in 6 countries.
Detailed Summary
Protocol CP-4-004-OLE (Open Label Extension) is designed as a long-term, open-label extension using single patient use, multi-dose, disposable pre-filled pen.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGrowth Hormone Deficiency (GHD)
CountriesBelarus, Greece, Hungary, Russia, Ukraine, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2014
First PostedJul 2015
Primary CompletionNov 2023
TodayJul 2026
First PostedJul 16, 2015
Enrollment StartFeb 1, 2014
Primary CompletionNov 1, 2023
TodayJul 2, 2026
Enrollment to primary: 9.8 yearsPosted 11.0 years ago
Interventions
MOD-4023drug
Once weekly injection of long acting r-hGH (MOD-4023) provided as a solution for injection containing 20 or 50 mg/mL MOD-4023 in a single patient use, multi-dose, disposable pre-filled pen (PEN).