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NCT01163097 · ClinicalTrials.gov registry record · Phase 1
Study to Characterize the Effect of Heparin on Palifermin Activity
A Phase 1 study, sponsored by Swedish Orphan Biovitrum.
- Completed
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
NCT01163097: Completed Phase 1 study, sponsored by Swedish Orphan Biovitrum.
NCT01163097 is a Phase 1 study that has completed, run by Swedish Orphan Biovitrum. The registered enrollment target is 44 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01163097, a Phase 1 study, has completed, sponsored by Swedish Orphan Biovitrum.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effect of a continuous intravenous infusion of unfractionated heparin on the multiple-dose pharmacodynamics of palifermin in healthy adult subjects.
Primary Outcome
This outcome is a measure of the palifermin effect on the buccal mucosal cells. Ki67 is a measure of proliferation of cells in the buccal mucosa. This measure assess the number of cells per millimeter (mm) before and after palifermin treatment.
Interventions
- DRUG Palifermin
- DRUG Heparin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2010-07 |
| Est. Completion | 2011-01 |
| Phase | Phase 1 |
What the finished NCT01163097 record still lists
NCT01163097 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 2 interventions - of which Palifermin is the first listed.
NCT01163097 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01163097 about?
NCT01163097 is a clinical study titled "Study to Characterize the Effect of Heparin on Palifermin Activity". The purpose of this study is to evaluate the effect of a continuous intravenous infusion of unfractionated heparin on the multiple-dose pharmacodynamics of palifermin in healthy adult subjects.
What is the current status of trial NCT01163097?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2010-07. Estimated completion is 2011-01.
What interventions are being tested in trial NCT01163097?
The interventions under investigation include: Palifermin (DRUG), Heparin (DRUG).
Who is sponsoring clinical trial NCT01163097?
This trial is sponsored by Swedish Orphan Biovitrum, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01163097's enrollment target sits among peer trials
44 1086th of 2000 higher than 901 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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