CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 44 enrolled
Drug / intervention
Palifermin +1 moredrug
Likely dose
Palifermin 40 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01163097
NCT01163097Phase 1Completed
CompareCT.gov

An Open-label, Randomized, Parallel-Design Study to Characterize the Effect of Heparin on Palifermin Activity in Healthy Adult Subjects

Swedish Orphan Biovitrum·interventional·Posted Jul 15, 2010·Updated Nov 6, 2014

In Brief

A Phase 1 clinical trial evaluating Palifermin and Heparin for Oral Mucositis. Completed, enrolled 44 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOral Mucositis
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 15, 2010
Enrollment StartJul 1, 2010
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 16.0 years ago

Interventions

Palifermindrug

40 µg/kg IV bolus injections for three consecutive days

Heparindrug

Heparin continuous IV infusion