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NCT01464164 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy Study of Sotatercept in Adults With Transfusion Dependent Diamond Blackfan Anemia
A Phase 1 study, sponsored by Northwell Health.
- Terminated
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT01464164: Clinical Trial Phase 1 study, sponsored by Northwell Health.
NCT01464164 is a Phase 1 study that was terminated before completion, run by Northwell Health. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01464164, a Phase 1 study, was terminated before completion, sponsored by Northwell Health.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety and dosing of drug Sotatercept, as a subcutaneous injection, to stimulate production of red blood cell production. To be given every 28 days for up to four doses.
Primary Outcome
Complete response is transfusion independence with hemoglobin \>9 gm/dl; partial response is transfusion dependence with hemoglobin \< 9gm/dl with an increase in reticulocyte count over baseline
Interventions
- DRUG Sotatercept
- DRUG Sotatercept with prednisone boost
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2012-01 |
| Est. Completion | 2021-04-13 |
| Phase | Phase 1 |
Why NCT01464164 stopped before completion
NCT01464164 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Sotatercept is the first listed.
NCT01464164 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01464164 about?
NCT01464164 is a clinical study titled "Safety and Efficacy Study of Sotatercept in Adults With Transfusion Dependent Diamond Blackfan Anemia". The purpose of this study is to determine the safety and dosing of drug Sotatercept, as a subcutaneous injection, to stimulate production of red blood cell production. To be given every 28 days for up to four doses.
What is the current status of trial NCT01464164?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2012-01. Estimated completion is 2021-04-13.
What interventions are being tested in trial NCT01464164?
The interventions under investigation include: Sotatercept (DRUG), Sotatercept with prednisone boost (DRUG).
Who is sponsoring clinical trial NCT01464164?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01464164's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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