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Safety Study of Alphanate in Previously Treated Patients With Severe Hemophilia A

NCT00323856 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2025-01-16

Study results available
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Summary

The purpose of this study is to determine the immunologic and overall safety associated with long-term use of Alphanate in subjects diagnosed with severe hemophilia A (Factor VIII:C less than 0.01 IU/ml), who have been previously treated with plasma-derived Factor VIII products other than Alphanate and who have no history of developing either antibody inhibitors to Factor VIII or nonspecific inhibitors of coagulation.

Conditions

  • Severe Hemophilia A

Interventions

DRUG

Alphanate SD/HT

Plasma-derived preparation of Factor VIII

Sponsors & Collaborators

  • Grifols Biologicals, LLC

    lead INDUSTRY

Principal Investigators

  • Michael Ken Woodward · Instituto Grifols SA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-08
Primary Completion
2018-12-11
Completion
2018-12-14
FDA Drug
Yes

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00323856 on ClinicalTrials.gov