Trial Outcomes & Findings for Study Evaluating Liver Transplantation in Haemophilia Patients in Spain (NCT NCT00927992)

NCT ID: NCT00927992

Last Updated: 2013-01-30

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 11 participants
• Primary outcome timeframe: Post liver transplantation up to Month 3
• Results posted on: 2013-01-30

Participant Flow

Participant milestones

Measure	Hemophiliac Participants With Liver Transplant Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study Evaluating Liver Transplantation in Haemophilia Patients in Spain

Baseline characteristics by cohort

Measure	Hemophiliac Participants With Liver Transplant n=11 Participants Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
Age Continuous	45.45 years STANDARD_DEVIATION 15.38 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Number of participants with Type A and B Hemophilia Type A	9 participants n=5 Participants
Number of participants with Type A and B Hemophilia Type B	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Post liver transplantation up to Month 3

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

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

Outcome measures

Measure	Hemophiliac Participants With Liver Transplant n=11 Participants Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
Number of Participants Requiring Immunosuppressive Therapy After Liver Transplantation Cyclosporine	7 Participants
Number of Participants Requiring Immunosuppressive Therapy After Liver Transplantation Corticosteroids	6 Participants
Number of Participants Requiring Immunosuppressive Therapy After Liver Transplantation Tacrolimus	4 Participants
Number of Participants Requiring Immunosuppressive Therapy After Liver Transplantation Mycophenolate Mofetil	3 Participants
Number of Participants Requiring Immunosuppressive Therapy After Liver Transplantation Everolimus	1 Participants

PRIMARY outcome

Timeframe: Post liver transplantation up to Month 3

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

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

Outcome measures

Measure	Hemophiliac Participants With Liver Transplant n=11 Participants Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
Number of Participants With Acute Rejection of Liver Transplant	0 Participants

PRIMARY outcome

Timeframe: Post liver transplantation up to Month 3

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

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.

Outcome measures

Measure	Hemophiliac Participants With Liver Transplant n=11 Participants Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
Number of Participants With Hepatitis C Viral Infection Recurrence After Liver Transplantation	4 Participants

PRIMARY outcome

Timeframe: Post liver transplantation up to Month 3

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

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.

Outcome measures

Measure	Hemophiliac Participants With Liver Transplant n=11 Participants Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
Number of Participants Who Survived After Liver Transplantation	10 Participants

SECONDARY outcome

Timeframe: Up to Day 5 post liver transplantation

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

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.

Outcome measures

Measure	Hemophiliac Participants With Liver Transplant n=11 Participants Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
Number of Participants Requiring Exogenous Clotting Factor Infusion During Liver Transplantation Bolus	5 Participants
Number of Participants Requiring Exogenous Clotting Factor Infusion During Liver Transplantation Continuous infusion	3 Participants

SECONDARY outcome

Timeframe: Up to Day 5 post liver transplantation

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

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.

Outcome measures

Measure	Hemophiliac Participants With Liver Transplant n=11 Participants Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
Dose of Exogenous Clotting Factors Used During Liver Transplantation	62.88 International Unit/kilogram (IU/kg) Standard Deviation 30.09

SECONDARY outcome

Timeframe: Post liver transplantation up to Month 3

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

Outcome measures

Outcome data not reported

Adverse Events

Hemophiliac Participants With Liver Transplant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER