Clinical trial · Interventional

Study Evaluating ReFacto AF in Severe Hemophilia A

An Open-Label Study to Characterize the Safety and Efficacy of BDDrFVIII Manufactured by the Albumin Free Process (ReFacto AF) in the Treatment of Previously Treated Patients (PTP) With Severe Hemophilia A

NCT00037544CI-TRIAL-00001421completedPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

To characterize the safety and efficacy of ReFacto AF in treating acute bleeding episodes during prophylaxis treatment, including neoantigenicity.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Hemophilia A	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
ReFacto AF	Drug	—	UNRESOLVED

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 12 Years

Show eligibility criteria text

Inclusion Criteria:

* Severe hemophilia A (FVIII:C less than or equal to 2% at local laboratory)
* Previously treated patients with greater than or equal to 250 exposure days to any Factor VIII product
* Age greater than or equal to 12 years
* History of prophylaxis dosing at least twice per week on any Factor VIII product for at least 3 consecutive months within the 2 years prior to study enrollment unless the patient completed the previous pharmacokinetic study
* Adequate laboratory results

Exclusion Criteria:

* Presence of any bleeding disorder in addition to hemophilia A
* Concomitant therapy with immunosuppressive drugs
* Current or historical Factor VIII inhibitor
* Treatment with any investigational drug or device within the past 30 days

References

Publications (0)

Data not yet available

No reference posted for this study.