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Long Term Follow up Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children
NCT02500316 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02500316
The ClinicalTrials.gov registry entry for NCT02500316 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OPKO Health, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02500316 reports 13 study locations spanning 2 distinct geographic areas — top geographies include Other, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02500316?
The interventions under investigation include: MOD-4023 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02500316?
This trial is sponsored by OPKO Health, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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