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NCT01190644 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate Effect of a Single Dose of Sotatercept (ACE-011) on Red Blood Cell Mass and Plasma Volume in Participants With Solid Tumors
A Phase 2 study, sponsored by Merck Sharp & Dohme.
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT01190644: Clinical Trial Phase 2 study, sponsored by Merck Sharp & Dohme.
NCT01190644 is a Phase 2 study that was terminated before completion, run by Merck Sharp & Dohme. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01190644, a Phase 2 study, was terminated before completion, sponsored by Merck Sharp & Dohme.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
What hematopoietic precursor compartments as well as hemoglobin subtypes are affected by dosing with sotatercept (ACE-011)? Based upon a similar prior study with Procrit, Celgene has determined that all of these goals could be obtained by an intense 10-patient sotatercept (ACE-011) pharmacodynamic study, completed by two well-known experts in the red cell production field.
Primary Outcome
Blood samples were to be collected at baseline (Day 1, pre-dose) and at one timepoint between Day 14 and Day 28, and isotope dilution techniques used, to measure the change from baseline in red blood cell mass following a single dose of sotatercept.
Interventions
- DRUG Sotatercept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2010-06-01 |
| Est. Completion | 2012-10-29 |
| Phase | Phase 2 |
Why NCT01190644 stopped before completion
NCT01190644 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Sotatercept is the first listed.
NCT01190644 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01190644 about?
NCT01190644 is a clinical study titled "Study to Evaluate Effect of a Single Dose of Sotatercept (ACE-011) on Red Blood Cell Mass and Plasma Volume in Participants With Solid Tumors". What hematopoietic precursor compartments as well as hemoglobin subtypes are affected by dosing with sotatercept (ACE-011)? Based upon a similar prior study with Procrit, Celgene has determined that all of these goals could be obtained by an intense 10-patient sotatercept (ACE-011) pharmacodynamic s...
What is the current status of trial NCT01190644?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2010-06-01. Estimated completion is 2012-10-29.
What interventions are being tested in trial NCT01190644?
The interventions under investigation include: Sotatercept (DRUG).
Who is sponsoring clinical trial NCT01190644?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01190644's enrollment target sits among peer trials
5 2000th of 2000 the lowest 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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