NCT00038909

Brief Summary

To identify the causative mutations in previously untreated patients with hemophilia A enrolled in the ReFacto® clinical safety and efficacy study CTN 93-R833-0XX/C9741-28, using two established hemophilia mutation testing laboratories (one in Europe and one in North America).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 1994

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1994

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2001

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 7, 2002

Completed
Last Updated

February 8, 2013

Status Verified

February 1, 2013

Enrollment Period

6.7 years

First QC Date

June 5, 2002

Last Update Submit

February 7, 2013

Conditions

Hemophilia A

Interventions

BDDrFVIIDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who were or are enrolled in Study CTN 93-R833-0XX/C9741-28, and have been treated with ReFacto® during this study are eligible for participation.
  • The patient (or legal guardian) must be willing to give written informed consent before any study-related procedures are performed.
  • A blood sample will be collected from each patient for the purpose of this study and will be analyzed at one or both of the designated central laboratories.

You may not qualify if:

  • Any condition which, in the investigator's opinion, places the patient at undue risk.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Medical Monitor, MD

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2002

First Posted

June 7, 2002

Study Start

September 1, 1994

Primary Completion

May 1, 2001

Study Completion

May 1, 2001

Last Updated

February 8, 2013

Record last verified: 2013-02