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Trial record 1 of 1 for:    NCT00927992
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Study Evaluating Liver Transplantation in Haemophilia Patients in Spain

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ClinicalTrials.gov Identifier: NCT00927992
Recruitment Status : Completed
First Posted : June 25, 2009
Results First Posted : January 30, 2013
Last Update Posted : January 30, 2013
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Cross-Sectional
Conditions Hemophilia
Hemophilia B
Intervention Other: Epidemiological Non interventional
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Hemophiliac Participants With Liver Transplant
Hide Arm/Group Description Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
Period Title: Overall Study
Started 11
Completed 11
Not Completed 0
Arm/Group Title Hemophiliac Participants With Liver Transplant
Hide Arm/Group Description Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants
45.45  (15.38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
0
   0.0%
Male
11
 100.0%
Number of participants with Type A and B Hemophilia  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11 participants
Type A 9
Type B 2
1.Primary Outcome
Title Number of Participants Requiring Immunosuppressive Therapy After Liver Transplantation
Hide Description Cyclosporine, corticosteroids, tacrolimus, mycophenolate mofetil, everolimus were considered as immunosuppressive therapy after liver transplantation.
Time Frame Post liver transplantation up to Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population included all the participants who met the eligibility criteria.
Arm/Group Title Hemophiliac Participants With Liver Transplant
Hide Arm/Group Description:
Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: Participants
Cyclosporine 7
Corticosteroids 6
Tacrolimus 4
Mycophenolate Mofetil 3
Everolimus 1
2.Primary Outcome
Title Number of Participants With Acute Rejection of Liver Transplant
Hide Description Any acute rejection of the liver transplant was clinically suspected and biopsy proven by central pathologist.
Time Frame Post liver transplantation up to Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population included all the participants who met the eligibility criteria.
Arm/Group Title Hemophiliac Participants With Liver Transplant
Hide Arm/Group Description:
Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: Participants
0
3.Primary Outcome
Title Number of Participants With Hepatitis C Viral Infection Recurrence After Liver Transplantation
Hide Description Number of participants who had liver transplantation after cirrhosis due to hepatitis C virus (HCV) infection and experienced recurrence of HCV infection post liver transplantation.
Time Frame Post liver transplantation up to Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population included all the participants who met the eligibility criteria.
Arm/Group Title Hemophiliac Participants With Liver Transplant
Hide Arm/Group Description:
Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: Participants
4
4.Primary Outcome
Title Number of Participants Who Survived After Liver Transplantation
Hide Description Number of participants who survived after liver transplantation was reported. The death reported was a result of acute-related transplantation complications and end-stage liver disease.
Time Frame Post liver transplantation up to Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population included all the participants who met the eligibility criteria.
Arm/Group Title Hemophiliac Participants With Liver Transplant
Hide Arm/Group Description:
Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: Participants
10
5.Secondary Outcome
Title Number of Participants Requiring Exogenous Clotting Factor Infusion During Liver Transplantation
Hide Description Exogenous clotting factors administered post liver transplant included Prothromplex; platelets, fibrinogen and fresh frozen plasma (FFP) combination; FFP and platelets combination. Clotting factors were administered either as bolus or as continuous infusion.
Time Frame Up to Day 5 post liver transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population included all the participants who met the eligibility criteria.
Arm/Group Title Hemophiliac Participants With Liver Transplant
Hide Arm/Group Description:
Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: Participants
Bolus 5
Continuous infusion 3
6.Secondary Outcome
Title Dose of Exogenous Clotting Factors Used During Liver Transplantation
Hide Description Exogenous clotting factors administered post liver transplant included Prothromplex; platelets, fibrinogen and fresh frozen plasma (FFP) combination; FFP and platelets combination. Clotting factors were administered either as bolus or as continuous infusion.
Time Frame Up to Day 5 post liver transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population included all the participants who met the eligibility criteria.
Arm/Group Title Hemophiliac Participants With Liver Transplant
Hide Arm/Group Description:
Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: International Unit/kilogram (IU/kg)
62.88  (30.09)
7.Secondary Outcome
Title Number of Participants With and Without Hemophilia Requiring Immunosuppressive Therapy, Had Acute Rejection, Hepatitis C Viral Infection Recurrence and Who Survived After Liver Transplantation
Hide Description [Not Specified]
Time Frame Post liver transplantation up to Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed as only hemophiliac participants were enrolled in the study.
Arm/Group Title Hemophiliac Participants With Liver Transplant
Hide Arm/Group Description:
Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description There were no adverse events collected in this retrospective study.
 
Arm/Group Title Hemophiliac Participants With Liver Transplant
Hide Arm/Group Description Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
All-Cause Mortality
Hemophiliac Participants With Liver Transplant
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Hemophiliac Participants With Liver Transplant
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Hemophiliac Participants With Liver Transplant
Affected / at Risk (%)
Total   0/0 
No outcomes were specified in the study protocol. Designation of outcomes as primary and secondary was based on study team’s input as study neither specifies nor prioritizes the outcomes.
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00927992     History of Changes
Other Study ID Numbers: B1831011
3082B1-4436 ( Other Identifier: Wyeth )
First Submitted: June 24, 2009
First Posted: June 25, 2009
Results First Submitted: December 20, 2012
Results First Posted: January 30, 2013
Last Update Posted: January 30, 2013