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Dose-Response Study of Recombinant Factor VIII Manufactured Protein-Free (rAHF-PFM) in Patients With Hemophilia A

Information source: Baxter Healthcare Corporation
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hemophilia A

Intervention: Antihemophilic factor, recombinant, manufactured protein-free (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Baxter Healthcare Corporation

Official(s) and/or principal investigator(s):
Deborah Brown, MD, Principal Investigator, Affiliation: The University of Texas Health Science Center, Houston
Ralph Gruppo, MD, Principal Investigator, Affiliation: Cincinnati Children´s Hospital Medical Center
Michael Tarantino, MD, Principal Investigator, Affiliation: Comprehensive Bleeding Disorders Center
Jorge Di Paola, MD, Principal Investigator, Affiliation: University of Iowa
Claire Philipp, MD, Principal Investigator, Affiliation: University of Medicine & Dentistry of NJ, Robert Wood Johnson Medical School
Kapil Saxena, MD, Principal Investigator, Affiliation: University of Oklahoma HSC
Doris V Quon, MD, Principal Investigator, Affiliation: Los Angeles Orthopaedic Hospital
Kimo Stine, MD, Principal Investigator, Affiliation: Arkansas Children´s Hospital

Summary

The purpose of this study is to determine the effect of 3 doses of ADVATE rAHF-PFM on initial recovery (% increase [IU/dL] per IU/kg infused) and major single-infusion pharmacokinetic parameters. The 3 doses are 15, 30, and 50 IU/kg. Prior to each infusion, subjects will not have received treatment with a factor VIII concentrate for at least 3 days. Blood samples will be drawn within 30 minutes pre-infusion and at 0. 25, 0. 5, 1, 3, 6, 9, 24, 28, 32 and 48 hours post-infusion. A washout period of at least 3 days, but no more than 30 days between the last blood draw and the next infusion will be observed. During participation, subjects will maintain their preexisting treatment regimens with ADVATE rAHF-PFM or other factor VIII concentrate.

A secondary objective is to investigate the relationship between pharmacokinetic parameters at each dose level and the levels of von Willebrand factor ristocetin cofactor activity and von Willebrand factor antigen at baseline.

Clinical Details

Official title: Advate Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method (ADVATE rAHF-PFM): A Phase 4 Study to Determine the Pharmacokinetic Response of Patients Diagnosed With Severe Hemophilia A to Different Doses of ADVATE rAHF-PFM

Study design: Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Pharmacokinetics Study

Primary outcome: Initial recovery (per-cent increase in IU/dL per IU/kg infused at 30 minutes post-infusion)

Eligibility

Minimum age: 12 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- The subject has severe hemophilia A as defined by a baseline factor VIII activity <1%

of normal; tested at screening. (A minimum washout period of 5 days is required before the blood sample can be drawn to determine baseline factor VIII levels.)

- The subject has a documented history of at least 150 exposure days to factor VIII

concentrates (either plasma-derived or recombinant).

- The subject is within 12 to 65 years of age.

- The subject has a Karnofsky performance score >60.

- The subject is human immunodeficiency virus negative (HIV-) or HIV+ with CD4 count

>=400 cells/mm3 (CD4 count determined at screening, if necessary).

- The subject or subject´s legally authorized representative has provided written

informed consent.

Exclusion Criteria:

- The subject has a known hypersensitivity to mouse or hamster proteins or to factor

VIII concentrates.

- The subject has a history of factor VIII inhibitors with titer >=0. 8 BU (Bethesda

Assay) or >=0. 4 BU (Nijmegen modification of the Bethesda Assay) any time prior to screening.

- The subject has a detectable factor VIII inhibitor at screening, >=0. 4 BU (Nijmegen

modification of the Bethesda Assay), in the Baxter central laboratory.

- The subject has severe chronic liver disease as evidenced by, but not limited to, any

of the following: International Normalized Ratio (INR) >1. 4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices.

- The subject has been diagnosed with an inherited or acquired hemostatic defect other

than hemophilia A (e. g. qualitative platelet defect or von Willebrand´s Disease).

- The subject has participated in another investigational study within 30 days of

enrollment.

- The subject´s clinical condition may require a major or moderate surgery (estimated

blood loss >500 mL) during the period of participation in the study.

Locations and Contacts

Arkansas Children´s Hospital, Little Rock, Arkansas 72202, United States

Los Angeles Orthopaedic Hospital, Los Angeles, California 90007, United States

Comprehensive Bleeding Disorders Center, Peoria, Illinois 61614, United States

University of Iowa Hospitals and Clinics, Iowa City, Iowa 52242, United States

University of Medicine & Dentistry of NJ, Robert Wood Johnson Medical School, New Brunswick, New Jersey 08903, United States

Cinicinnati Children´s Hospital Medical Center, Hemophilia Treatment Center, Cincinnati, Ohio 45229, United States

University of Oklahoma HSC, Division of Pediatric Hematology/Oncology, Oklahoma City, Oklahoma 73104, United States

University of Texas Health Sciences Center, Gulf States Hemophilia & Thrombophilia Center, HMC, Houston, Texas 77030, United States

Additional Information

Starting date: January 2006
Last updated: February 4, 2008

Page last updated: June 20, 2008

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