Study Evaluating Liver Transplantation in Haemophilia Patients in Spain

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00927992
• Collaborator: (none)
• Enrollment: 11
• Duration (Months): 11

Study Details

Study Description

Brief Summary

This study will analyze survival and outcome of patients with severe haemophilia who undergo liver transplantation in Spain

Condition or Disease	Intervention/Treatment	Phase
Hemophilia; Hemophilia B	Other: Epidemiological Non interventional

Detailed Description

Probability Sample

Study Design

• Study Type: Observational
• Actual Enrollment: 11 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Liver Transplantation in Haemophilia Patients in Spain
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Jun 1, 2010
• Actual Study Completion Date: Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: Epidemiological Non interventional; Epidemiological Non interventional

Outcome Measures

Primary Outcome Measures

1. Number of Participants Requiring Immunosuppressive Therapy After Liver Transplantation [Post liver transplantation up to Month 3]

   Cyclosporine, corticosteroids, tacrolimus, mycophenolate mofetil, everolimus were considered as immunosuppressive therapy after liver transplantation.

2. Number of Participants With Acute Rejection of Liver Transplant [Post liver transplantation up to Month 3]

   Any acute rejection of the liver transplant was clinically suspected and biopsy proven by central pathologist.

3. Number of Participants With Hepatitis C Viral Infection Recurrence After Liver Transplantation [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.

4. Number of Participants Who Survived After Liver Transplantation [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.

Secondary Outcome Measures

1. Number of Participants Requiring Exogenous Clotting Factor Infusion During Liver Transplantation [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.

2. Dose of Exogenous Clotting Factors Used During Liver Transplantation [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.

3. Number of Participants With and Without Hemophilia Requiring Immunosuppressive Therapy, Had Acute Rejection, Hepatitis C Viral Infection Recurrence and Who Survived After Liver Transplantation [Post liver transplantation up to Month 3]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
• ClinicalTrials.gov Identifier: NCT00927992
• Other Study ID Numbers: B1831011; 3082B1-4436
• First Posted: Jun 25, 2009
• Last Update Posted: Jan 30, 2013
• Last Verified: Dec 1, 2012

• Additional relevant MeSH terms: Hemophilia A; Hemophilia B

Study Results

Participant Flow

Arm/Group Title	Hemophiliac Participants With Liver Transplant
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

Baseline Characteristics

Arm/Group Title	Hemophiliac Participants With Liver Transplant
Arm/Group Description	Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
Overall Participants	11
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.45 (15.38)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	11 100%
Number of participants with Type A and B Hemophilia (participants) [Number]
Type A	9 81.8%
Type B	2 18.2%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Requiring Immunosuppressive Therapy After Liver Transplantation
Description	Cyclosporine, corticosteroids, tacrolimus, mycophenolate mofetil, everolimus were considered as immunosuppressive therapy after liver transplantation.
Time Frame	Post liver transplantation up to Month 3

Outcome Measure Data

Analysis Population Description

Evaluable population included all the participants who met the eligibility criteria.

Arm/Group Title	Hemophiliac Participants With Liver Transplant
Arm/Group Description	Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
Measure Participants	11
Cyclosporine	7 63.6%
Corticosteroids	6 54.5%
Tacrolimus	4 36.4%
Mycophenolate Mofetil	3 27.3%
Everolimus	1 9.1%

2. Primary Outcome

Title	Number of Participants With Acute Rejection of Liver Transplant
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

Outcome Measure Data

Analysis Population Description

Evaluable population included all the participants who met the eligibility criteria.

Arm/Group Title	Hemophiliac Participants With Liver Transplant
Arm/Group Description	Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
Measure Participants	11
Number [Participants]	0 0%

3. Primary Outcome

Title	Number of Participants With Hepatitis C Viral Infection Recurrence After Liver Transplantation
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

Outcome Measure Data

Analysis Population Description

Evaluable population included all the participants who met the eligibility criteria.

Arm/Group Title	Hemophiliac Participants With Liver Transplant
Arm/Group Description	Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
Measure Participants	11
Number [Participants]	4 36.4%

4. Primary Outcome

Title	Number of Participants Who Survived After Liver Transplantation
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

Outcome Measure Data

Analysis Population Description

Evaluable population included all the participants who met the eligibility criteria.

Arm/Group Title	Hemophiliac Participants With Liver Transplant
Arm/Group Description	Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
Measure Participants	11
Number [Participants]	10 90.9%

5. Secondary Outcome

Title	Number of Participants Requiring Exogenous Clotting Factor Infusion During Liver Transplantation
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

Outcome Measure Data

Analysis Population Description

Evaluable population included all the participants who met the eligibility criteria.

Arm/Group Title	Hemophiliac Participants With Liver Transplant
Arm/Group Description	Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
Measure Participants	11
Bolus	5 45.5%
Continuous infusion	3 27.3%

6. Secondary Outcome

Title	Dose of Exogenous Clotting Factors Used During Liver Transplantation
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

Outcome Measure Data

Analysis Population Description

Evaluable population included all the participants who met the eligibility criteria.

Arm/Group Title	Hemophiliac Participants With Liver Transplant
Arm/Group Description	Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
Measure Participants	11
Mean (Standard Deviation) [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
Time Frame	Post liver transplantation up to Month 3

Outcome Measure Data

Analysis Population Description

Data was not analyzed as only hemophiliac participants were enrolled in the study.

Arm/Group Title	Hemophiliac Participants With Liver Transplant
Arm/Group Description	Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
Measure Participants	0

Adverse Events

Adverse Event Reporting Description	There were no adverse events collected in this retrospective study.
Arm/Group Title	Hemophiliac Participants With Liver Transplant
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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Hemophiliac Participants With Liver Transplant
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Hemophiliac Participants With Liver Transplant
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.