Study Evaluating BDDRFVIII and ReFacto AF in Hemophilia A | NCT00038935

Studies
Study Evaluating BDDRFVIII and ReFacto AF in Hemophilia A

NCT00038935

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Status

Completed

Last Update Posted

Apr 22, 2008Estimated

Enrollment

Not provided

Phase

Phase 3

Conditions

Hemophilia A

Interventions

ReFacto AF

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official Title

A Single Dose, Randomized, Double-Blind, 2-Period Crossover Study in Patients With Hemophilia A to Evaluate the Pharmacokinetics of B-Domain Deleted Recombinant Human Factor VIII (BDDrFVIII) Manufactured by the Current Process (ReFacto) and by an Albumin Free Manufacturing Process (ReFacto AF)

Status Module

Record Verification Date

Apr 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Not provided

Primary Completion Date

Feb 2003Actual

Completion Date

Feb 2003Actual

First Submitted Date

Jun 5, 2002

First Submission Date that Met QC Criteria

Jun 6, 2002

First Posted Date

Jun 7, 2002Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2008

Last Update Posted Date

Apr 22, 2008Estimated

Description Module

Brief Summary

The purpose of this study is to determine the relative bioavailability of ReFacto AF as compared to ReFacto, when each is administered as 2-minute bolus infusions.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
ReFacto AF	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Severe hemophilia A (FVIII:C < 1% at local laboratory)
Previously treated patients (PTP) with at least 250 exposure days to any factor VIII product
Age greater than or equal to 12 years\

Exclusion Criteria:

The presence of any bleeding disorder in addition to hemophilia A
Concomitant therapy with immunosuppressant drugs (e.g., intravenous immunoglobulin (IVIG), routine systemic corticosteroid use)
History of detectable factor VIII inhibitor

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Monitor, MD	Wyeth is now a wholly owned subsidiary of Pfizer	Study Director

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29575770	Derived	Korth-Bradley J, Rupon J, Plotka A, Charnigo R, Rendo P. Assessment of Relative Bioavailability of Moroctocog Alfa and Moroctocog Alfa (AF-CC) in Subjects With Severe Hemophilia A. Clin Transl Sci. 2018 May;11(3):283-288. doi: 10.1111/cts.12544. Epub 2018 Mar 25.

ID	Term
D025861	Blood Coagulation Disorders, Inherited
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Term
D001779	Blood Coagulation Factors
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins