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NCT02962648 · ClinicalTrials.gov registry record · Phase 3
An Extension Trial to Assess the Safety of Re-dosing of Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®)
A Phase 3 study of Iron Deficiency Anemia and Iron Deficiency Anaemia, sponsored by Pharmacosmos A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 103
- Enrollment target
- 20
- Study locations
NCT02962648 is a Phase 3 study of Iron Deficiency Anemia and Iron Deficiency Anaemia that has completed, run by Pharmacosmos A/S. The registered enrollment target is 103 participants, below the 189-participant average among 24 other Iron Deficiency Anemia trials with a reported enrollment target (46% lower). The trial reports 20 study locations across 7 states.
The verdict
NCT02962648, a Phase 3 study of Iron Deficiency Anemia and Iron Deficiency Anaemia, has completed, sponsored by Pharmacosmos A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 103 participants
- Enrollment target
- 20
- Study locations
Study Summary
Evaluate safety and efficacy of intravenous (IV) iron isomaltoside/ferric derisomaltose re-dosing, in subjects who were previously treated with iron isomaltoside/ferric derisomaltose.
Conditions Studied
Interventions
- DRUG Iron isomaltoside/ferric derisomaltose
Study Locations (20)
Florida
- Pharmacosmos Investigational Site - Doral
- Pharmacosmos Investigational Site - Hialeah
- Pharmacosmos Investigational Site - Miami
- Pharmacosmos Investigational Site - Miami
- Pharmacosmos Investigational Site - Miami
- Pharmacosmos Investigational Site - Miami Lakes
- Pharmacosmos Investigational Site - West Palm Beach
California
- Pharmacosmos Investigational Site - Chula Vista
- Pharmacosmos Investigational Site 1 - La Mesa
- Pharmacosmos Investigational Site 2 - La Mesa
- Pharmacosmos Investigational Site - Northridge
- Pharmacosmos Investigational Site - Porterville
Louisiana
- Pharmacosmos Investigational Site - Baton Rouge
- Pharmacosmos Investigational Site - Metairie
- Pharmacosmos Investigational Site - New Orleans
- Pharmacosmos Investigational Site - Shreveport
New Jersey
- Pharmacosmos Investigational Site - Plainsboro
New Mexico
- Pharmacosmos Investigational Site - Albuquerque
Tennessee
- Pharmacosmos Investigational Site - Chattanooga
Texas
- Pharmacosmos Investigational Site - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2017-01-09 |
| Est. Completion | 2018-06-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02962648
The ClinicalTrials.gov registry entry for NCT02962648 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 189-participant average among 24 other Iron Deficiency Anemia trials with a reported enrollment target (46% lower). The listed sponsor is Pharmacosmos A/S, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Iron Deficiency Anemia appearing as the primary indexed condition, and to 1 intervention - of which Iron isomaltoside/ferric derisomaltose is the first listed.
NCT02962648 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Florida, California, Louisiana.
Frequently Asked Questions
What is clinical trial NCT02962648 about?
NCT02962648 is a clinical study titled "An Extension Trial to Assess the Safety of Re-dosing of Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®)". Evaluate safety and efficacy of intravenous (IV) iron isomaltoside/ferric derisomaltose re-dosing, in subjects who were previously treated with iron isomaltoside/ferric derisomaltose.
What is the current status of trial NCT02962648?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 103 participants. The study started on 2017-01-09. Estimated completion is 2018-06-12.
What conditions does trial NCT02962648 study?
This clinical trial studies the following conditions: Iron Deficiency Anemia, Iron Deficiency Anaemia.
What interventions are being tested in trial NCT02962648?
The interventions under investigation include: Iron isomaltoside/ferric derisomaltose (DRUG).
Who is sponsoring clinical trial NCT02962648?
This trial is sponsored by Pharmacosmos A/S, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02962648 being conducted?
This trial has 20 study locations across California, Florida, Louisiana, New Jersey, New Mexico. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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