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NCT03398824 · ClinicalTrials.gov registry record · Phase 2
Pilot Study of Metformin for Patients With Fanconi Anemia
A Phase 2 study, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT03398824: Completed Phase 2 study, sponsored by Boston Children's Hospital.
NCT03398824 is a Phase 2 study that has completed, run by Boston Children's Hospital. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03398824, a Phase 2 study, has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
This is a single institution, open-label, single arm pilot study of Metformin in patients with Fanconi Anemia (FA) and cytopenias with the primary endpoint of hematologic response. This study will also assess safety, tolerability, and the biologic effects of Metformin in patients with FA.
Primary Outcome
Hematologic response is defined by specific increases in erythroid, platelet, and neutrophil counts. Erythroid response: Hemoglobin (Hgb) increase by \>1.5g/dL for non-transfusion dependent patients and for patients who are transfusion dependent: Transfusion independence Only transfusions given for Hgb ≤8g/dL or for symptoms will be counted in the response evaluation Platelet response: If initially \<20k/uL to start, then must increase to \>20k/UL with an absolute increase of 100%. If initiall
Interventions
- DRUG metformin HCl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2018-03-29 |
| Est. Completion | 2020-10-09 |
| Phase | Phase 2 |
What the finished NCT03398824 record still lists
NCT03398824 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which metformin HCl is the first listed.
NCT03398824 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03398824 about?
NCT03398824 is a clinical study titled "Pilot Study of Metformin for Patients With Fanconi Anemia". This is a single institution, open-label, single arm pilot study of Metformin in patients with Fanconi Anemia (FA) and cytopenias with the primary endpoint of hematologic response. This study will also assess safety, tolerability, and the biologic effects of Metformin in patients with FA.
What is the current status of trial NCT03398824?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2018-03-29. Estimated completion is 2020-10-09.
What interventions are being tested in trial NCT03398824?
The interventions under investigation include: metformin HCl (DRUG).
Who is sponsoring clinical trial NCT03398824?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03398824's enrollment target sits among peer trials
15 1919th of 2000 higher than 60 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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