Study Evaluating ReFacto AF in Severe Hemophilia A

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

ReFacto AF

About this trial

This is an interventional treatment trial for Hemophilia A focused on measuring Severe, Hemophilia, A

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00037544

First Posted

May 17, 2002

Last Updated

April 18, 2008

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00037544

Brief Title

Study Evaluating ReFacto AF in Severe Hemophilia A

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2008

Overall Recruitment Status

Completed

Study Start Date

undefined (undefined)

Primary Completion Date

August 2004 (Actual)

Study Completion Date

August 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemophilia A

Keywords

Severe, Hemophilia, A

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

ReFacto AF

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor, MD

Organizational Affiliation

Wyeth is now a wholly owned subsidiary of Pfizer

Official's Role

Study Director

Hemophilia A

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial