Oral MucositisPhase 1NCT01163097

Study to Characterize the Effect of Heparin on Palifermin Activity

A Phase 1 study testing Palifermin and Heparin in people with Oral Mucositis, run by Swedish Orphan Biovitrum at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Oral Mucositis
What is being tested?: Palifermin and Heparin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 1 siteUnited States
Study dates: Jul 2010to Jan 2011
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy men or postmenopausal or oophorectomized women.
Subjects should have a Body Mass Index between 19 and 30 inclusive.
A negative screen for drug abuse, tobacco use and alcohol breath test.
Subjects should be willing to be resident in the research facility for up to 6 nights and return to the research facility for scheduled study and follow-up procedures.
Men must agree for the duration of the study to use an appropriate method of birth control

Who cannot join

History or evidence of clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
History or evidence of any oral mucosal disease that may affect mucosal keratinocyte proliferation.
Evidence or history of thrombocytopenia, heparin-induced thrombocytopenia or other contraindications to heparin (e.g. recent surgeries).
Known hypersensitivity to heparin or topical or injectable local anesthetic.
Known allergies to Escherichia coli-derived products or allergies to palifermin or its excipients.
Use of medications (except vitamins, hormonal replacement therapy and topical medications) within 10 days of admission to research facility.

Show all 15Show fewer

Blood donation within 8 weeks prior to dosing of investigational drug.
History of hypertension, clinically significant bleeding, gastrointestinal ulcers, arteriovenous malformation (AVM), aneurysm, or other vascular malformation.
History of coagulopathy, bleeding disorders or abnormal platelet counts.
History of malignancy of any type, other than surgically excised non-melanoma skin cancers or in situ cervical cancer.
For males, past history of epididymitis.
Known alcohol abuse or use of illicit drugs within 12 months prior to admission to the research facility.
History of smoking or using smokeless tobacco within the past year before admission to the research facility.
Any other condition that might reduce the chance of obtaining data (eg, known poor compliance) required by the protocol or that might compromise the ability to give informed consent.
Previous participation in a palifermin study.

Trial locations and contacts

1 site in 1 country.

United States1 site

New Orleans Center for Clinical Research (NOCCR)
Knoxville, Tennessee, 37920

Other trials in United States

About this study

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

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.

Read the detailed description

The planned study is designed to characterize the impact of heparin on the biologic activity of palifermin and assess the impact of the combination of palifermin and heparin on tolerability. Approximately forty-three (43) eligible healthy adult men and oophorectomized or postmenopausal women between 18-45 years of age will be assigned to one of three treatment groups where treatment group A will receive a daily dose of palifermin 40 µg/kg for three consecutive days as intravenous (IV) bolus injections and continuous heparin IV infusion, treatment B will receive a daily dose of palifermin 40 µg/kg for three consecutive days as IV bolus injections and treatment C will be a control group without any treatment administered. The subjects will be randomized in a 20:15:8 ratio (Treatment A:B:C).

The study consists of a up to 21-days screening period, a 5-days treatment period and a up to 45-days follow-up period.

Conditions: Oral Mucositis
Being tested: Palifermin, Heparin
Medical subject headings: Stomatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PaliferminDrug
40 µg/kg IV bolus injections for three consecutive days
HeparinDrug
Heparin continuous IV infusion

Study groups in NCT01163097
Study group	Role	What they receive
Palifermin 40 µg/kg and heparin IV infusion	Experimental	Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion Receives: Drug: Palifermin; Drug: Heparin
Palifermin 40 µg/kg	Experimental	Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections Receives: Drug: Palifermin
Control group without any treatment	No intervention	Treatment C: control group without any treatment administered.

What is being measured

The primary outcome is the main question the study is designed to answer.

Ratio to Baseline of Epithelial Cell Proliferation as Assessed by Ki67 Staining of Buccal Mucosal Tissue.
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.
Measured: Day 4
Incidence of Grade 2 or Higher Specific Skin-related Adverse Events.
Incidence of grade 2 or higher specific skin-related treatment emergent adverse events following palifermin administration was calculated for subjects in treatment groups A and B. Incidence was calculated by treatment as number of subjects with grade 2 or higher specific skin-related AEs divided by the total number of subjects.
The Common Terminology Criteria for Adverse Events (CTCAE v3.0) for Dermatology/Skin was used to determine the toxicity grade for a skin-related adverse event. (http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcaev3.pdf)
Measured: Day 45
Ratio to Baseline of Amylase
Ratio to baseline amylase at Day 5 was calculated as Day 5 amylase divided by baseline amylase.
Measured: Day 5
Ratio to Baseline of Lipase.
Ratio to baseline lipase at Day 5 was calculated as Day 5 lipase divided by baseline lipase.
Measured: Day 5
Ratio to Baseline of Protein/Creatinine
Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result.
Ratio to baseline protein/creatinine ratio was calculated as protein/creatinine ratio at specified day divided by baseline protein/creatinine ratio.
Measured: Day 4

Secondary outcomes (17)

Palifermin Pharmacokinetic (PK) Parameters: Clearance (CL)
Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.
Descriptive PK parameters for palifermin CL for subjects assigned to Treatment A and Treatment B was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero.
Measured: Day 1
Palifermin PK Parameters: CL
Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.
Descriptive PK parameters for palifermin CL for subjects assigned to Treatment A and Treatment B was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero.
Measured: Day 3
Palifermin PK Parameters: Area Under the Serum Curve (AUC) (0-24)
Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.
Descriptive pharmacokinetic parameters for palifermin AUC(0-24) was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was deleted from calculation.
Measured: Day 1
Palifermin PK Parameters: AUC (0-24)
Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.
Descriptive pharmacokinetic parameters for palifermin AUC(0-24) was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was deleted from calculation.
Measured: Day 3
Palifermin PK Parameters: Estimated Concentration at Time 0 (C0)
Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.
Descriptive pharmacokinetic parameters for palifermin C0 was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero.
Measured: Day 1
Palifermin PK Parameters: C0
Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.
Descriptive pharmacokinetic parameters for palifermin C0 was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero.
Measured: Day 3
Palifermin PK Parameters: Apparent Volume of Distribution at Steady State (Vss)
Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin (Treatment A and Treatment B only).
Descriptive pharmacokinetic parameters for palifermin Vss was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero.
Measured: Day 1
Palifermin PK Parameters: Vss
Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin (Treatment A and Treatment B only).
Descriptive pharmacokinetic parameters for palifermin Vss was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero.
Measured: Day 3
Subject Incidence of Treatment-emergent Adverse Event
Adverse events (AE) was considered treatment emergent if the AE started after the time of heparin titration (Treatment A), palifermin dosing on Day 1 (Treatment B), or set zero point (Treatment C).
Measured: Day 45
Subject Incidence of Proteinuria
Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result at the specified time point.
Incidence of proteinuria defined as urinary protein/creatinine ratio exceeding 200 mg/g was calculated at Day 4 and overall at any time point. Incidence was calculated by treatment as number of subjects with proteinuria divided by the total number of subjects.
Measured: Day 4
Ratio to Baseline of Protein/Creatinine
Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result.
Ratio to baseline protein/creatinine ratio was calculated as protein/creatinine ratio at specified day divided by baseline protein/creatinine ratio.
Measured: Day 1
Ratio to Baseline of Protein/Creatinine
Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result.
Ratio to baseline protein/creatinine ratio was calculated as protein/creatinine ratio at specified day divided by baseline protein/creatinine ratio.
Measured: Day 2
Ratio to Baseline of Protein/Creatinine
Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result.
Ratio to baseline protein/creatinine ratio was calculated as protein/creatinine ratio at specified day divided by baseline protein/creatinine ratio.
Measured: Day 3
Ratio to Baseline of Albumin/Creatinine
The albumin/creatinine ratio is the urinary albumin (mg) divided by the urinary creatinine (g) result at the specified time point.
Ratio to baseline was calculated as albumin/creatinine ratio at specified day divided by baseline albumin/creatinine ratio.
Measured: Day 1
Ratio to Baseline of Albumin/Creatinine
The albumin/creatinine ratio is the urinary albumin (mg) divided by the urinary creatinine (g) result at the specified time point.
Ratio to baseline was calculated as albumin/creatinine ratio at specified day divided by baseline albumin/creatinine ratio.
Measured: Day 2
Ratio to Baseline of Albumin/Creatinine
The albumin/creatinine ratio is the urinary albumin (mg) divided by the urinary creatinine (g) result at the specified time point.
Ratio to baseline was calculated as albumin/creatinine ratio at specified day divided by baseline albumin/creatinine ratio.
Measured: Day 3
Ratio to Baseline of Albumin/Creatinine
The albumin/creatinine ratio is the urinary albumin (mg) divided by the urinary creatinine (g) result at the specified time point.
Ratio to baseline was calculated as albumin/creatinine ratio at specified day divided by baseline albumin/creatinine ratio.
Measured: Day 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2010Jan 2011

First posted15 Jul 2010 (estimated)
Study startJul 2010
Primary completionJan 2011
Study completionJan 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Oral MucositisStudies of the same condition, open and under way.
More trials run by Swedish Orphan BiovitrumThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01163097
Sponsor's protocol ID: 20070278
Status last verified: Oct 2014
First submitted: 14 Jul 2010
Last updated: 6 Nov 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Yang BB, Gillespie B, Smith B, Smith W, Lissmats A, Rudebeck M, Kullenberg T, Olsson B. Pharmacokinetic and pharmacodynamic interactions between palifermin and heparin. J Clin Pharmacol. 2015 Oct;55(10):1109-18. doi: 10.1002/jcph.516. Epub 2015 May 28.
PubMed 25880826

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Randomized, Parallel-Design Study to Characterize the Effect of Heparin on Palifermin Activity in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT01163097
Acronym / sponsor ID: 20070278
Conditions: Oral Mucositis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Swedish Orphan BiovitrumIndustry (pharma, biotech, devices)
Study start: Jul 2010
Primary completion: Jan 2011 (actual)
Study completion: Jan 2011 (actual)
First posted: 15 Jul 2010 (estimated)
Results: Posted 23 Aug 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

The study consists of a up to 21-days screening period, a 5-days treatment period and a up to 45-days follow-up period.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Palifermin 40 µg/kg and heparin IV infusion	Experimental	Drug: Palifermin, Drug: HeparinTreatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
Palifermin 40 µg/kg	Experimental	Drug: PaliferminTreatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
Control group without any treatment	No intervention	–Treatment C: control group without any treatment administered.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Healthy men or postmenopausal or oophorectomized women.
Subjects should have a Body Mass Index between 19 and 30 inclusive.
A negative screen for drug abuse, tobacco use and alcohol breath test.
Subjects should be willing to be resident in the research facility for up to 6 nights and return to the research facility for scheduled study and follow-up procedures.
Men must agree for the duration of the study to use an appropriate method of birth control

Key exclusion criteria (15 listed)

History or evidence of clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
History or evidence of any oral mucosal disease that may affect mucosal keratinocyte proliferation.
Evidence or history of thrombocytopenia, heparin-induced thrombocytopenia or other contraindications to heparin (e.g. recent surgeries).
Known hypersensitivity to heparin or topical or injectable local anesthetic.
Known allergies to Escherichia coli-derived products or allergies to palifermin or its excipients.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Palifermin40 µg/kg IV bolus injections for three consecutive days	Drug	Palifermin 40 µg/kg, Palifermin 40 µg/kg and heparin IV infusion
HeparinHeparin continuous IV infusion	Drug	Palifermin 40 µg/kg and heparin IV infusion

Primary outcome

Ratio to Baseline of Epithelial Cell Proliferation as Assessed by Ki67 Staining of Buccal Mucosal Tissue.
Time frame: Day 4
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.
Incidence of Grade 2 or Higher Specific Skin-related Adverse Events.
Time frame: Day 45
Incidence of grade 2 or higher specific skin-related treatment emergent adverse events following palifermin administration was calculated for subjects in treatment groups A and B. Incidence was calculated by treatment as number of subjects with grade 2 or higher specific skin-related AEs divided by the total number of subjects. The Common Terminology Criteria for Adverse Events (CTCAE v3.0) for Dermatology/Skin was used to determine the toxicity grade for a skin-related adverse event. (http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcaev3.pdf)
Ratio to Baseline of Amylase
Time frame: Day 5
Ratio to baseline amylase at Day 5 was calculated as Day 5 amylase divided by baseline amylase.
Ratio to Baseline of Lipase.
Time frame: Day 5
Ratio to baseline lipase at Day 5 was calculated as Day 5 lipase divided by baseline lipase.
Ratio to Baseline of Protein/Creatinine
Time frame: Day 4
Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result. Ratio to baseline protein/creatinine ratio was calculated as protein/creatinine ratio at specified day divided by baseline protein/creatinine ratio.

17 secondary outcomes

Palifermin Pharmacokinetic (PK) Parameters: Clearance (CL)
Time frame: Day 1
Palifermin PK Parameters: CL
Time frame: Day 3
Palifermin PK Parameters: Area Under the Serum Curve (AUC) (0-24)
Time frame: Day 1
Palifermin PK Parameters: AUC (0-24)
Time frame: Day 3
Palifermin PK Parameters: Estimated Concentration at Time 0 (C0)
Time frame: Day 1
Palifermin PK Parameters: C0
Time frame: Day 3
Palifermin PK Parameters: Apparent Volume of Distribution at Steady State (Vss)
Time frame: Day 1
Palifermin PK Parameters: Vss
Time frame: Day 3
Subject Incidence of Treatment-emergent Adverse Event
Time frame: Day 45
Subject Incidence of Proteinuria
Time frame: Day 4
Ratio to Baseline of Protein/Creatinine
Time frame: Day 1
Ratio to Baseline of Protein/Creatinine
Time frame: Day 2
Ratio to Baseline of Protein/Creatinine
Time frame: Day 3
Ratio to Baseline of Albumin/Creatinine
Time frame: Day 1
Ratio to Baseline of Albumin/Creatinine
Time frame: Day 2
Ratio to Baseline of Albumin/Creatinine
Time frame: Day 3
Ratio to Baseline of Albumin/Creatinine
Time frame: Day 4

Results and safety

Results posted to the registry on 23 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Palifermin - Heparin	20	14
Palifermin Alone	16	16
Untreated Control	8	8

Primary outcome: Ratio to Baseline of Epithelial Cell Proliferation as Assessed by Ki67 Staining of Buccal Mucosal Tissue.

Time frame: Day 4. Geometric mean (90% Confidence Interval). Unit: ratio

Measure	Palifermin - Heparin n = 14	Palifermin Alone n = 16
Value	0.267 (0.173 to 0.361)	0.414 (0.326 to 0.502)

Palifermin - Heparin vs Palifermin Alone: Geometric mean ratio: 0.863 (90% CI 0.759 to 0.982), ANCOVA

Population analysed: The pharmacodynamic population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B), or who had a set zero point (Treatment C) and had both baseline and Day 4 buccal biopsy samples collected. This analysis was only performed for Treatment A relative to Treatment B as per study plan.

Primary outcome: Incidence of Grade 2 or Higher Specific Skin-related Adverse Events.

Time frame: Day 45. Number. Unit: proportion of participants

Measure	Palifermin - Heparin n = 15	Palifermin Alone n = 16
Value	0	0.0625

Population analysed: The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B), or who had a set zero point (Treatment C). This outcome was assessed for Treatment A and B only as per study plan.

Primary outcome: Ratio to Baseline of Amylase

Time frame: Day 5. Geometric mean (95% Confidence Interval). Unit: ratio

Measure	Palifermin - Heparin n = 15	Palifermin Alone n = 16
Value	0.242 (0.111 to 0.372)	0.547 (0.420 to 0.673)

Palifermin - Heparin vs Palifermin Alone: Geometric mean: 0.737 (95% CI 0.614 to 0.885), ANCOVA

Population analysed: The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment A and B only as per study plan.

Primary outcome: Ratio to Baseline of Lipase.

Time frame: Day 5. Geometric mean (95% Confidence Interval). Unit: ratio

Measure	Palifermin - Heparin n = 15	Palifermin Alone n = 16
Value	-0.487 (-0.873 to -0.100)	0.499 (0.125 to 0.873)

Palifermin - Heparin vs Palifermin Alone: Geometric mean: 0.373 (95% CI 0.216 to 0.645), ANCOVA

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: From signing of informed consent to subject´s end of study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Palifermin - Heparin	0 of 20 (0%)	9 of 20 (45%)	Not reported
Palifermin Alone	0 of 16 (0%)	9 of 16 (56.3%)	Not reported
Untreated Control	0 of 8 (0%)	3 of 8 (37.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25880826Yang BB, Gillespie B, Smith B, Smith W, Lissmats A, Rudebeck M, Kullenberg T, Olsson B. Pharmacokinetic and pharmacodynamic interactions between palifermin and heparin. J Clin Pharmacol. 2015 Oct;55(10):1109-18. doi: 10.1002/jcph.516. Epub 2015 May 28.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Maarten de Chateau, MD PhD study director

Swedish Orphan Biovitrum

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Palifermin and Heparin in people with Oral Mucositis, run by Swedish Orphan Biovitrum at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ratio to Baseline of Epithelial Cell Proliferation as Assessed by Ki67 Staining of Buccal Mucosal Tissue. (time frame: Day 4). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01163097, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2014.