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| Sponsor: | Baxter Healthcare Corporation |
|---|---|
| Information provided by: | Baxter Healthcare Corporation |
| ClinicalTrials.gov Identifier: | NCT00289536 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hemophilia A |
Drug: Antihemophilic factor, recombinant, manufactured protein-free |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Pharmacokinetics Study |
| 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 |
| Estimated Enrollment: | 25 |
| Study Start Date: | January 2006 |
| Study Completion Date: | June 2008 |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Dose of 15 IU/kg
|
Drug: Antihemophilic factor, recombinant, manufactured protein-free
The enrolled subjects will receive 3 infusions of ADVATE rAHF PFM at doses of 15, 30, and 50 IU/kg in a randomized order for the pharmacokinetic evaluation. The duration between pharmacokinetic infusions will be at least 3 days and not more than 30 days.
|
|
2: Active Comparator
Dose of 30 IU/kg
|
Drug: Antihemophilic factor, recombinant, manufactured protein-free
The enrolled subjects will receive 3 infusions of ADVATE rAHF PFM at doses of 15, 30, and 50 IU/kg in a randomized order for the pharmacokinetic evaluation. The duration between pharmacokinetic infusions will be at least 3 days and not more than 30 days.
|
|
3: Active Comparator
Dose of 50 IU/kg
|
Drug: Antihemophilic factor, recombinant, manufactured protein-free
The enrolled subjects will receive 3 infusions of ADVATE rAHF PFM at doses of 15, 30, and 50 IU/kg in a randomized order for the pharmacokinetic evaluation. The duration between pharmacokinetic infusions will be at least 3 days and not more than 30 days.
|
Eligibility| Ages Eligible for Study: | 12 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Arkansas | |
| Arkansas Children´s Hospital | |
| Little Rock, Arkansas, United States, 72202 | |
| United States, California | |
| Los Angeles Orthopaedic Hospital | |
| Los Angeles, California, United States, 90007 | |
| United States, Illinois | |
| Comprehensive Bleeding Disorders Center | |
| Peoria, Illinois, United States, 61614 | |
| United States, Iowa | |
| University of Iowa Hospitals and Clinics | |
| Iowa City, Iowa, United States, 52242 | |
| United States, New Jersey | |
| University of Medicine & Dentistry of NJ, Robert Wood Johnson Medical School | |
| New Brunswick, New Jersey, United States, 08903 | |
| United States, Ohio | |
| Cinicinnati Children´s Hospital Medical Center, Hemophilia Treatment Center | |
| Cincinnati, Ohio, United States, 45229 | |
| United States, Oklahoma | |
| University of Oklahoma HSC, Division of Pediatric Hematology/Oncology | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Texas | |
| University of Texas Health Sciences Center, Gulf States Hemophilia & Thrombophilia Center, HMC | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Deborah Brown, MD | The University of Texas Health Science Center, Houston |
| Principal Investigator: | Ralph Gruppo, MD | Cincinnati Children´s Hospital Medical Center |
| Principal Investigator: | Michael Tarantino, MD | Comprehensive Bleeding Disorders Center |
| Principal Investigator: | Jorge Di Paola, MD | University of Iowa |
| Principal Investigator: | Claire Philipp, MD | University of Medicine & Dentistry of NJ, Robert Wood Johnson Medical School |
| Principal Investigator: | Kapil Saxena, MD | University of Oklahoma HSC |
| Principal Investigator: | Doris V Quon, MD | Los Angeles Orthopaedic Hospital |
| Principal Investigator: | Kimo Stine, MD | Arkansas Children´s Hospital |
More Information
| Responsible Party: | Baxter Healthcare Corporation ( Jorge Escobar, Clinical Project Manager ) |
| Study ID Numbers: | 060403 |
| Study First Received: | February 9, 2006 |
| Last Updated: | July 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00289536 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Hemorrhagic Disorders Blood Coagulation Disorders, Inherited Coagulants Genetic Diseases, Inborn Coagulation Protein Disorders Hematologic Diseases |
Therapeutic Uses Blood Coagulation Disorders Hematologic Agents Hemophilia A Pharmacologic Actions Factor VIII |