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NCT02453334 · ClinicalTrials.gov registry record · Phase 3
Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Study to Investigate the Efficacy and Safety of Injectafer®
A Phase 3 study, sponsored by American Regent.
- Completed
- Registry status
- Phase 3
- Development phase
- 244
- Enrollment target
NCT02453334: Completed Phase 3 study, sponsored by American Regent.
NCT02453334 is a Phase 3 study that has completed, run by American Regent. The registered enrollment target is 244 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02453334, a Phase 3 study, has completed, sponsored by American Regent.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 244 participants
- Enrollment target
Study Summary
Phase III, multicenter, randomized, double-blinded, prospective study with two parallel treatment groups. Patients who present to the hematologist/oncologist and satisfy all inclusion and exclusion criteria will be eligible for participation in this 18-week study.
Primary Outcome
The following participants will be considered to have met the primary endpoint: * Participants with observed Hgb decrease from baseline between 0.5 g/dL to 1.0 g/dL on two consecutive visits between Weeks 3 and 18. * Participants with observed Hgb decrease from baseline ≥1.0 g/dL at one visit. * Participants who have a non-study intervention prior to Week 18. * Participants who discontinue prior to Week 18 for lack of efficacy or adverse events.
Interventions
- OTHER Normal Saline
- DRUG Injectafer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 244 participants |
| Start Date | 2015-05-23 |
| Est. Completion | 2018-01-04 |
| Phase | Phase 3 |
What the finished NCT02453334 record still lists
NCT02453334 is an interventional study that assigns participants to a tested intervention. The registered 244 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Normal Saline is the first listed.
NCT02453334 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02453334 about?
NCT02453334 is a clinical study titled "Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Study to Investigate the Efficacy and Safety of Injectafer®". Phase III, multicenter, randomized, double-blinded, prospective study with two parallel treatment groups. Patients who present to the hematologist/oncologist and satisfy all inclusion and exclusion criteria will be eligible for participation in this 18-week study.
What is the current status of trial NCT02453334?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 244 participants. The study started on 2015-05-23. Estimated completion is 2018-01-04.
What interventions are being tested in trial NCT02453334?
The interventions under investigation include: Normal Saline (OTHER), Injectafer (DRUG).
Who is sponsoring clinical trial NCT02453334?
This trial is sponsored by American Regent, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02453334's enrollment target sits among peer trials
244 1269th of 2000 higher than 732 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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