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Gammagard Liquid and rHuPH20 in PID

Information source: Baxter Healthcare Corporation
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Primary Immunodeficiency Diseases (PID)

Intervention: Recombinant human hyaluronidase + immune globulin intravenous (Biological); Recombinant human hyaluronidase + immune globulin intravenous (Biological)

Phase: Phase 3

Status: Recruiting

Sponsored by: Baxter Healthcare Corporation

Official(s) and/or principal investigator(s):
Baxter BioScience Investigator, MD, Study Director, Affiliation: Baxter Healthcare Corporation

Summary

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.

Clinical Details

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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Primary outcome: The primary endpoint is the validated acute serious bacterial infection rate, defined as the mean number of validated acute serious bacterial infections per subject per year in the intent-to-treat population.

Eligibility

Minimum age: 2 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subject is 2 years or older at the time of screening

- Written informed consent obtained from either the subject or the subject's legally

acceptable representative prior to any study-related procedures and study product administration

- Subject has been diagnosed with a PID disorder requiring antibody replacement as

defined by WHO criteria

- Subject has completed or is about to complete Baxter Clinical Study Protocol No.

160601 or has been receiving a regular IGIV-treatment at mean intervals of 21 ± 3 days or 28 ± 3 days, or SC at mean intervals of 5 to 16 days, over a period of at least 3 months prior to enrollment at a minimum dose of 300 mg/kg BW/4 weeks

- Subject has a serum trough level of IgG > 4. 5 g/L at the last documented

determination

- If female of childbearing potential, subject presents with a negative urine pregnancy

test and agrees to employ adequate birth control measures for the duration of the study

- Subject is willing and able to comply with the requirements of the protocol

Exclusion Criteria:

- Subject is positive at enrollment or screening for one or more of the following:

Hepatitis B surface antigen (HbsAg), polymerase chain reaction (PCR) for Hepatitis C Virus (HCV), PCR for Human immunodeficiency virus (HIV) Type 1/2

- Subject has levels of alanine aminotransferase (ALT) or aspartate amino transferase

(AST) > 2. 5 times the upper limit of normal for the testing laboratory

- Subject has persistent severe neutropenia (defined as an absolute neutrophil count

[ANC] <= 500/mm3)

- Subject has creatinine clearance values, calculated according to the formula below,

which are < 60% of normal for age and gender for males: CLcr = [(140 - Age(years)) *

(body weight (kg))] / [72 * (Serum Creatinine (mg/dL))] for females: CLcr = [(140 -

Age(years)) * (body weight(kg)) * 0. 85] / [72 * (Serum Creatinine (mg/dL))]

- Subject has malignancy other than adequately treated basal cell or squamous cell

carcinoma of the skin or carcinoma in situ of the cervix

- Subject has a history of thrombotic episodes (including deep vein thrombosis,

myocardial infarction, cerebrovascular accident, pulmonary embolism) within the last 12 months

- Subject has abnormal protein loss (protein losing enteropathy, nephrotic syndrome)

- Subject has anemia that would preclude phlebotomy for laboratory studies

- Subject has received any blood or blood product other than an IGIV, SC immunoglobulin,

immune serum globulin (ISG) preparation, or albumin within the 6 months prior to enrollment

- Subject has an ongoing history of hypersensitivity or persistent reactions (urticaria,

breathing difficulty, severe hypotension, or anaphylaxis) following IGIV, SC immunoglobulin, and/or ISG infusions

- Subject has immunoglobulin A (IgA) deficiency and known anti IgA antibodies

- Subject is on preventative (prophylactic) antibiotics and cannot stop antibiotics at

the time of enrollment

- Subject has active infection who started on antibiotic therapy for the treatment of

infection within 7 days prior to screening

- Subject has a bleeding disorder or are on anti-coagulation therapy

- Subject has total protein > 9 g/dL and subjects with myeloma, macroglobulinemia (IgM)

and paraproteinemia

- Subject has a known allergy to hyaluronidase

- If female, subject is pregnant or lactating at the time of study enrollment

- Subject has participated in another clinical study involving an investigational

product (IP) or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an IP or device during the course of this study; exception: Baxter Study No. 160601

Locations and Contacts

First Allergy & Clinical Research Center, Centennial, Colorado 80112, United States; Recruiting
Isaac Melamed, MD, Phone: 303-773-9000, Email: allergyandresearch@yahoo.com
Isaac Melamed, MD, Principal Investigator
Additional Information

Starting date: December 2008
Last updated: December 29, 2008

Page last updated: February 12, 2009

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