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Study to Characterize the Effect of Heparin on Palifermin Activity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier:
NCT01163097
First received: July 14, 2010
Last updated: October 31, 2014
Last verified: October 2014
Results First Received: January 17, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Oral Mucositis
Interventions: Drug: Palifermin
Drug: Heparin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This open-label, randomized, parallel-design, Phase I study in healthy adult subjects was performed in 1 center (New Orleans Center for Clinical Research, Knoxville, TN, USA) between July and December 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects randomized to receive palifermin in combination with heparin did first enter a titration period where they received titrated heparin doses to achieve an aPTT of 1.5 to 2.0 × baseline. Subjects who could not be successfully titrated within the heparin titration period were discontinued, and did not enter the palifermin treatment period.

Reporting Groups
  Description
Palifermin - Heparin Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
Palifermin Alone Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
Untreated Control Treatment C: control group without any treatment administered

Participant Flow:   Overall Study
    Palifermin - Heparin     Palifermin Alone     Untreated Control  
STARTED     20 [1]   16     8  
COMPLETED     14     16     8  
NOT COMPLETED     6     0     0  
[1] 15 subjects were successfully titrated and entered the palifermin treatment



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Palifermin - Heparin Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
Palifermin Alone Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
Untreated Control Treatment C: control group without any treatment administered
Total Total of all reporting groups

Baseline Measures
    Palifermin - Heparin     Palifermin Alone     Untreated Control     Total  
Number of Participants  
[units: participants]
  15     16     8     39  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     15     16     8     39  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  25.9  ± 5.29     32.9  ± 7.82     22.8  ± 3.62     28.1  ± 7  
Gender  
[units: participants]
       
Female     0     0     0     0  
Male     15     16     8     39  
Ethnicity (NIH/OMB)  
[units: participants]
       
Hispanic or Latino     1     0     0     1  
Not Hispanic or Latino     14     16     8     38  
Unknown or Not Reported     0     0     0     0  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     0     0     0     0  
Asian     0     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     3     2     1     6  
White     12     14     7     33  
More than one race     0     0     0     0  
Unknown or Not Reported     0     0     0     0  
Region of Enrollment  
[units: participants]
       
United States     15     16     8     39  
Body Mass Index  
[units: kg/m2]
Mean ± Standard Deviation
  24.95  ± 2.144     26.08  ± 2.111     25.98  ± 3.185     25.62  ± 2.5  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Ratio to Baseline of Epithelial Cell Proliferation as Assessed by Ki67 Staining of Buccal Mucosal Tissue.   [ Time Frame: Day 4 ]

2.  Primary:   Incidence of Grade 2 or Higher Specific Skin-related Adverse Events.   [ Time Frame: Day 45 ]

3.  Primary:   Ratio to Baseline of Amylase   [ Time Frame: Day 5 ]

4.  Primary:   Ratio to Baseline of Lipase.   [ Time Frame: Day 5 ]

5.  Primary:   Ratio to Baseline of Protein/Creatinine   [ Time Frame: Day 4 ]

6.  Secondary:   Palifermin Pharmacokinetic (PK) Parameters: Clearance (CL)   [ Time Frame: Day 1 ]

7.  Secondary:   Palifermin PK Parameters: CL   [ Time Frame: Day 3 ]

8.  Secondary:   Palifermin PK Parameters: Area Under the Serum Curve (AUC) (0-24)   [ Time Frame: Day 1 ]

9.  Secondary:   Palifermin PK Parameters: AUC (0-24)   [ Time Frame: Day 3 ]

10.  Secondary:   Palifermin PK Parameters: Estimated Concentration at Time 0 (C0)   [ Time Frame: Day 1 ]

11.  Secondary:   Palifermin PK Parameters: C0   [ Time Frame: Day 3 ]

12.  Secondary:   Palifermin PK Parameters: Apparent Volume of Distribution at Steady State (Vss)   [ Time Frame: Day 1 ]

13.  Secondary:   Palifermin PK Parameters: Vss   [ Time Frame: Day 3 ]

14.  Secondary:   Subject Incidence of Treatment-emergent Adverse Event   [ Time Frame: Day 45 ]

15.  Secondary:   Subject Incidence of Proteinuria   [ Time Frame: Day 4 ]

16.  Secondary:   Ratio to Baseline of Protein/Creatinine   [ Time Frame: Day 1 ]

17.  Secondary:   Ratio to Baseline of Protein/Creatinine   [ Time Frame: Day 2 ]

18.  Secondary:   Ratio to Baseline of Protein/Creatinine   [ Time Frame: Day 3 ]

19.  Secondary:   Ratio to Baseline of Albumin/Creatinine   [ Time Frame: Day 1 ]

20.  Secondary:   Ratio to Baseline of Albumin/Creatinine   [ Time Frame: Day 2 ]

21.  Secondary:   Ratio to Baseline of Albumin/Creatinine   [ Time Frame: Day 3 ]

22.  Secondary:   Ratio to Baseline of Albumin/Creatinine   [ Time Frame: Day 4 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Program Director
Organization: Swedish Orphan Biovitrum
phone: +46 8 697 20 00
e-mail: clinical@sobi.com


No publications provided


Responsible Party: Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier: NCT01163097     History of Changes
Other Study ID Numbers: 20070278
Study First Received: July 14, 2010
Results First Received: January 17, 2012
Last Updated: October 31, 2014
Health Authority: United States: Food and Drug Administration