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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

Tracking Information
First Submitted Date June 24, 2009
First Posted Date June 25, 2009
Results First Submitted Date December 20, 2012
Results First Posted Date January 30, 2013
Last Update Posted Date January 30, 2013
Study Start Date July 2009
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 20, 2012)
  • Number of Participants Requiring Immunosuppressive Therapy After Liver Transplantation [ Time Frame: Post liver transplantation up to Month 3 ]
    Cyclosporine, corticosteroids, tacrolimus, mycophenolate mofetil, everolimus were considered as immunosuppressive therapy after liver transplantation.
  • Number of Participants With Acute Rejection of Liver Transplant [ Time Frame: Post liver transplantation up to Month 3 ]
    Any acute rejection of the liver transplant was clinically suspected and biopsy proven by central pathologist.
  • Number of Participants With Hepatitis C Viral Infection Recurrence After Liver Transplantation [ Time Frame: Post liver transplantation up to Month 3 ]
    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.
  • Number of Participants Who Survived After Liver Transplantation [ Time Frame: Post liver transplantation up to Month 3 ]
    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.
Original Primary Outcome Measures
 (submitted: June 24, 2009)
Survival and outcome of patients with severe haemophilia who undergo liver transplantation [ Time Frame: 3 months ]
Change History Complete list of historical versions of study NCT00927992 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 20, 2012)
  • Number of Participants Requiring Exogenous Clotting Factor Infusion During Liver Transplantation [ Time Frame: Up to Day 5 post liver transplantation ]
    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.
  • Dose of Exogenous Clotting Factors Used During Liver Transplantation [ Time Frame: Up to Day 5 post liver transplantation ]
    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.
  • Number of Participants With and Without Hemophilia Requiring Immunosuppressive Therapy, Had Acute Rejection, Hepatitis C Viral Infection Recurrence and Who Survived After Liver Transplantation [ Time Frame: Post liver transplantation up to Month 3 ]
Original Secondary Outcome Measures
 (submitted: June 24, 2009)
  • To estimate the treatment, dosage, units and infusion used during surgery [ Time Frame: 3 months ]
  • To compare the outcomes of liver transplantation for people with and without haemophilia [ Time Frame: 3 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study Evaluating Liver Transplantation in Haemophilia Patients in Spain
Official Title Liver Transplantation in Haemophilia Patients in Spain
Brief Summary This study will analyze survival and outcome of patients with severe haemophilia who undergo liver transplantation in Spain
Detailed Description Probability Sample
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with haemophilia who underwent liver transplantation and who have been followed-up at any site in Spain.
Condition
  • Hemophilia
  • Hemophilia B
Intervention Other: Epidemiological Non interventional
Epidemiological Non interventional
Study Groups/Cohorts Patients with haemophilia who undergo liver transplantation
Patients with haemophilia who underwent liver transplantation and who have been followed up at any site in Spain.
Intervention: Other: Epidemiological Non interventional
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 22, 2010)
11
Original Estimated Enrollment
 (submitted: June 24, 2009)
10
Actual Study Completion Date June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with haemophilia who underwent liver transplantation and who have been followed-up at any site in Spain.

Exclusion Criteria:

  • Patients without informed consent form.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries Spain
 
Administrative Information
NCT Number NCT00927992
Other Study ID Numbers B1831011
3082B1-4436 ( Other Identifier: Wyeth )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2012