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NCT02500316 · ClinicalTrials.gov registry record · Phase 2
Long Term Follow up Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children
A Phase 2 study of Growth Hormone Deficiency (GHD), sponsored by OPKO Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
- 13
- Study locations
NCT02500316: Completed Phase 2 study of Growth Hormone Deficiency (GHD), sponsored by OPKO Health.
NCT02500316 is a Phase 2 study of Growth Hormone Deficiency (GHD) that has completed, run by OPKO Health. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). The trial reports 13 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02500316, a Phase 2 study of Growth Hormone Deficiency (GHD), has completed, sponsored by OPKO Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
- 13
- Study locations
Study 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.
Primary Outcome
A summary of the annualized HV at the end of each year for Periods III/IV (OLE Years 1 - 4) and V (PEN Years 1 - 5).
Conditions Studied
Interventions
- DRUG MOD-4023
Study Locations (13)
Other
- 2DKB - Minsk
- Children's Hospital "P. A. Kyriakou" - Athens
- Buda Children's Hospital - Budapest
- Endocrinology Scientific Centre, Institute of Child Endocrinology - Moscow
- Russian Medical Academy of Postgraduate Education - Moscow
- SPGPMA - Saint Petersburg
- SamGMU - Samara
- SBEIHPE - Ufa
- Donetsk Regional Children Clinical Hospital - Donetsk
- Institute of Endocrinology - Kiev
- Ukrainian Scientific Center of Endocrine Surgery Moh of Ukraine - Kiev
- Odessa Regional Children'S Clinical Hospital - Odesa
Florida
- Nemours Children's Clinic - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2014-02 |
| Est. Completion | 2023-11 |
| Phase | Phase 2 |
What the finished NCT02500316 record still lists
NCT02500316 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 1 condition, with Growth Hormone Deficiency (GHD) appearing as the primary indexed condition, and to 1 intervention - of which MOD-4023 is the first listed.
NCT02500316 lists 13 locations in 2 states (Other, Florida).
Frequently Asked Questions
What is clinical trial NCT02500316 about?
NCT02500316 is a clinical study titled "Long Term Follow up Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children". 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.
What is the current status of trial NCT02500316?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2014-02. Estimated completion is 2023-11.
What conditions does trial NCT02500316 study?
This clinical trial studies the following conditions: Growth Hormone Deficiency (GHD).
What interventions are being tested in trial NCT02500316?
The interventions under investigation include: MOD-4023 (DRUG).
Who is sponsoring clinical trial NCT02500316?
This trial is sponsored by OPKO Health, which has 32 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02500316 being conducted?
This trial has 13 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Growth Hormone Deficiency (GHD)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02500316's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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