HemophiliaNCT00927992

Study Evaluating Liver Transplantation in Haemophilia Patients in Spain

An observational study of Hemophilia and Hemophilia B, run by Wyeth is now a wholly owned subsidiary of Pfizer.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Any age
Conditions the study is for: Hemophilia, Hemophilia B
What is being tested?: Epidemiological Non interventional
How many people: 11 participants
Where: No sites listed yet
Study dates: Jul 2009to Jun 2010
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

Patients without informed consent form.

About this study

Official title: Liver Transplantation in Haemophilia Patients in Spain

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

Read the detailed description

Probability Sample

Conditions: Hemophilia, Hemophilia B
Being tested: Epidemiological Non interventional
Medical subject headings: Hemophilia A, Hemophilia B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Epidemiological Non interventionalOther
Epidemiological Non interventional

Study groups in NCT00927992
Study group	Role	What they receive
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. Receives: Other: Epidemiological Non interventional

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Requiring Immunosuppressive Therapy After Liver Transplantation
Cyclosporine, corticosteroids, tacrolimus, mycophenolate mofetil, everolimus were considered as immunosuppressive therapy after liver transplantation.
Measured: Post liver transplantation up to Month 3
Number of Participants With Acute Rejection of Liver Transplant
Any acute rejection of the liver transplant was clinically suspected and biopsy proven by central pathologist.
Measured: Post liver transplantation up to Month 3
Number of Participants With Hepatitis C Viral Infection Recurrence After Liver Transplantation
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.
Measured: Post liver transplantation up to Month 3
Number of Participants Who Survived After Liver Transplantation
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.
Measured: Post liver transplantation up to Month 3

Secondary outcomes (3)

Number of Participants Requiring Exogenous Clotting Factor Infusion During 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.
Measured: Up to Day 5 post liver transplantation
Dose of Exogenous Clotting Factors Used During 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.
Measured: Up to Day 5 post liver transplantation
Number of Participants With and Without Hemophilia Requiring Immunosuppressive Therapy, Had Acute Rejection, Hepatitis C Viral Infection Recurrence and Who Survived After Liver Transplantation
Measured: Post liver transplantation up to Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2009Jun 2010

First posted25 Jun 2009 (estimated)
Study startJul 2009
Primary completionJun 2010
Study completionJun 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HemophiliaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00927992
Sponsor's protocol ID: B1831011
Other IDs: 3082B1-4436
Status last verified: Dec 2012
First submitted: 24 Jun 2009
Last updated: 30 Jan 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
Active, not recruitingObservational study
A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.
Hemophilia A or B
RecruitingPhase 1/2
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A
Hemophilia A
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B
Hemophilia B
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B

All Hemophilia trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Liver Transplantation in Haemophilia Patients in Spain
ClinicalTrials.gov ID: NCT00927992
Acronym / sponsor ID: B1831011
Conditions: Hemophilia, Hemophilia B
Study type: Observational
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
Study start: Jul 2009
Primary completion: Jun 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 25 Jun 2009 (estimated)
Results: Posted 30 Jan 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Probability Sample

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
Patients with haemophilia who undergo liver transplantation	–	Other: Epidemiological Non interventionalPatients with haemophilia who underwent liver transplantation and who have been followed up at any site in Spain.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients with haemophilia who underwent liver transplantation and who have been followed-up at any site in Spain.

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

Patients without informed consent form.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Epidemiological Non interventionalEpidemiological Non interventional	Other	Patients with haemophilia who undergo liver transplantation

Primary outcome

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.

3 secondary outcomes

Number of Participants Requiring Exogenous Clotting Factor Infusion During Liver Transplantation
Time frame: Up to Day 5 post liver transplantation
Dose of Exogenous Clotting Factors Used During Liver Transplantation
Time frame: Up to Day 5 post liver transplantation
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

Results and safety

Results posted to the registry on 30 Jan 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hemophiliac Participants With Liver Transplant	11	11

Primary outcome: Number of Participants Requiring Immunosuppressive Therapy After Liver Transplantation

Time frame: Post liver transplantation up to Month 3. Number. Unit: Participants

Measure	Hemophiliac Participants With Liver Transplant n = 11
Cyclosporine	7
Corticosteroids	6
Tacrolimus	4
Mycophenolate Mofetil	3
Everolimus	1

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

Primary outcome: Number of Participants With Acute Rejection of Liver Transplant

Time frame: Post liver transplantation up to Month 3. Number. Unit: Participants

Measure	Hemophiliac Participants With Liver Transplant n = 11
Value	0

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

Primary outcome: Number of Participants With Hepatitis C Viral Infection Recurrence After Liver Transplantation

Time frame: Post liver transplantation up to Month 3. Number. Unit: Participants

Measure	Hemophiliac Participants With Liver Transplant n = 11
Value	4

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

Primary outcome: Number of Participants Who Survived After Liver Transplantation

Time frame: Post liver transplantation up to Month 3. Number. Unit: Participants

Measure	Hemophiliac Participants With Liver Transplant n = 11
Value	10

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

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hemophiliac Participants With Liver Transplant	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Hemophilia

RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
Active, not recruitingObservational study
A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.
Hemophilia A or B
RecruitingPhase 1/2
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A
Hemophilia A
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B
Hemophilia B
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

Questions about this trial

What is this clinical trial studying?

An observational study of Hemophilia and Hemophilia B, run by Wyeth is now a wholly owned subsidiary of Pfizer.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Requiring Immunosuppressive Therapy After Liver Transplantation (time frame: Post liver transplantation up to Month 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00927992.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2013.