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| Study 1 of 1 for search of: | gammagard hyaluronidase |
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| Sponsor: | Baxter Healthcare Corporation |
|---|---|
| Information provided by: | Baxter Healthcare Corporation |
| ClinicalTrials.gov Identifier: | NCT00814320 |
Purpose
The purpose of the study is to develop a subcutaneous treatment option for subjects with PID that allows an administration of Immune Globulin Intravenous (Human), 10% at the same frequency as IV administration.
| Condition | Intervention | Phase |
|---|---|---|
|
Primary Immunodeficiency Diseases (PID) |
Biological: Recombinant human hyaluronidase + immune globulin intravenous |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Efficacy, Tolerability and Pharmacokinetic Comparison of Immune Globulin Intravenous (Human), 10% (GAMMAGARD LIQUID/KIOVIG) Administered Intravenously or Subcutaneously Following Administration of Recombinant Human Hyaluronidase (rHuPH20) in Subjects With Primary Immunodeficiency Diseases |
| Estimated Enrollment: | 80 |
| Study Start Date: | December 2008 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Efficacy and tolerability of SC infusions
|
Biological: Recombinant human hyaluronidase + immune globulin intravenous
Comprises subjects previously participating in Study 160601, who now only complete Study Epoch 2 (SC infusions) as bioavailability/exposure for IV treatment was already obtained in Study 160601. Study Epoch 2: Dose (calculated) of rHuPH20 followed by dose (calculated) of IGIV, 10% by SC infusion. Treatment intervals and doses are to be increased as defined, until treatment interval is the same as the pre-study treatment interval for IV treatment. |
|
2: Experimental
Pharmacokinetics of IV treatment and efficacy and tolerability of SC infusions
|
Biological: Recombinant human hyaluronidase + immune globulin intravenous
Comprises all other subjects. Study Epoch 1: IV infusion of IGIV, 10% (same dose and frequency as pre-study) to determine pharmacokinetics. Study Epoch 2: Dose (calculated) of rHuPH20 followed by dose (calculated) of IGIV, 10% by SC infusion. Treatment intervals and doses are to be increased as defined, until treatment interval is the same as the pre-study treatment interval for IV treatment. |
Eligibility| Ages Eligible for Study: | 2 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| University of California | |
| San Francisco, California, United States, 94143 | |
| West Coast Clinical Trials | |
| Long Beach, California, United States, 90806 | |
| Children´s Hospital Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| UCLA Schoold of Medicine / UCLA Medical Center, Dept. of Pediatrics | |
| Los Angeles, California, United States, 90095 | |
| University of California, Irvine | |
| Irvine, California, United States, 92697 | |
| United States, Colorado | |
| First Allergy & Clinical Research Center | |
| Centennial, Colorado, United States, 80112 | |
| United States, Florida | |
| Allergy Associates of the Palm Beaches, P.a. | |
| North Palm Beach, Florida, United States, 33408 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| Allergy and Asthma Physicians | |
| Hinsdale, Illinois, United States, 60521 | |
| United States, Nebraska | |
| Allergy Asthma & Immunology Associates | |
| Omaha, Nebraska, United States, 68124 | |
| United States, New York | |
| Montefiore Medical Center, Allergy & Immunology Division | |
| Bronx, New York, United States, 10461 | |
| United States, Texas | |
| Dallas Allergy Immunology Research, 7777 Forest Lane, Suite B-332 | |
| Dallas, Texas, United States, 75230 | |
| University of Texas Medical Branch | |
| Galveston, Texas, United States, 77555-0561 | |
| United States, Wisconsin | |
| Asthma/Allergy & Clinical Immunology, Medical College of Wisconsin, 9000 W. Wisconsin Ave. Suite 440 | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Canada, British Columbia | |
| St. Paul´s Hospital | |
| Vancouver, British Columbia, Canada, V6Z 1Y6 | |
| Study Director: | Baxter BioScience Investigator, MD | Baxter Healthcare Corporation |
More Information
| Responsible Party: | Baxter Healthcare Corporation ( Richard Schiff, MD ) |
| Study ID Numbers: | 160603 |
| Study First Received: | December 23, 2008 |
| Last Updated: | October 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00814320 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Antibodies Immunologic Factors Immune System Diseases Immunoglobulins, Intravenous Physiological Effects of Drugs |
Rho(D) Immune Globulin Pharmacologic Actions Immunologic Deficiency Syndromes Immunoglobulins |