A Study to Find How Safe and Effective GAMMAPLEX® is in Subjects With Chronic Idiopathic Thrombocytopenic Purpura (ITP) - Full Text View

Sponsored by:	Bio Products Laboratory
Information provided by:	Bio Products Laboratory
ClinicalTrials.gov Identifier:	NCT00504075

Purpose

The primary objective is to determine if BPL's GAMMAPLEX raises the platelet count of subjects with chronic ITP to a threshold of 50 x 109/L, similar to that of a historical control. The secondary objectives are: 1) to determine the safety of GAMMAPLEX at the dosage used in this study. 2) to determine if GAMMAPLEX maintains platelet counts of ³ 50 x 109/L in subjects with chronic ITP for a period of time similar to that of a historical control.

Condition	Intervention	Phase
Chronic Idiopathic Thrombocytopenic Purpura	Biological: Gammaplex, intravenous immunoglobulin Biological: Gammaplex	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase III, Multicenter, Open-Label Study To Evaluate the Efficacy and Safety of GAMMAPLEX® in Chronic Idiopathic Thrombocytopenic Purpura

Resource links provided by NLM:

Genetics Home Reference related topics: hemophilia thrombotic thrombocytopenic purpura

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Further study details as provided by Bio Products Laboratory:

Primary Outcome Measures:

The primary objective is to determine if BPL's GAMMAPLEX raises the platelet count of subjects with chronic ITP to a threshold of 50 x 109/L, similar to that of a historical control. [ Time Frame: 3 to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the safety of GAMMAPLEX at the dosage used in this study and to determine if GAMMAPLEX maintains platelet counts of ³ 50 x 109/L in subjects with chronic ITP for a period of time similar to that of a historical control. [ Time Frame: 3 to 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	31
Study Start Date:	August 2007
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Intervention Details:

The first course of GAMMAPLEX will be administered as an intravenous infusion of 1 g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen may be administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.

Gammaplex® contains 5 g/100 mL of human normal immunoglobulin (i.e. 50 g/L, of which virtually 100% is IgG). The first course of GAMMAPLEX will be administered as an intravenous infusion of 1 g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen may be administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.

Dosage form: Gammaplex® is a sterile liquid of 5 % w/v normal immunoglobulin. Gammaplex® contains 5 g/100 mL of human normal immunoglobulin (i.e. 50 g/L, of which virtually 100% is IgG). The first course of GAMMAPLEX will be administered as an intravenous infusion of 1 g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen may be administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.

Eligibility

Ages Eligible for Study:	6 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males and females aged between 6 and 70 years.
Confirmed diagnosis of chronic ITP of at least 6 months duration.
Platelet count of less than or equal to 20 x 10 9/L at enrollment.
Absence of other conditions that, in the opinion of the investigator, could cause thrombocytopenia.
If subjects are currently being treated with corticosteroids the treatment regimen/dose must have been stable (for a minimum of 2 weeks before screening). However, subjects must remain on a stable treatment regimen. If there is any intent to alter the corticosteroid treatment regimen (e.g., tapering of corticosteroids) before Day 10, subjects may not be included in the study.
If subjects are currently being treated with cyclophosphamide, azathioprine or attenuated androgens, the treatment regimen and dose must have been stable for a minimum of 2 months before screening. However, if there is any intent to alter the treatment regimen before Day 10, subjects may not be included in the study.
Splenectomized subjects and both Rh(D)+ and Rh(D)- subjects may be included.
The subject has signed an informed consent form (if at least 18 years old) or the subject's parent or legal guardian has signed the informed consent form. If appropriate, the subject has signed a child assent form.
If a subject is a female of child-bearing potential, she must have a negative result on a urine-based HCG pregnancy test.
If a subject is a female who is or becomes sexually active, she must practice contraception by using a method of proven reliability for the duration of the study.

Exclusion Criteria:

The subject has a history of any severe or anaphylactic reaction to blood or any blood-derived product, or any severe reaction to IGIV or any other IgG preparation.
The subject is known to be intolerant to any component of the investigational product.
The subject has received any live virus vaccine within the last 3 months.
The subject has received an IGIV preparation within 1 month prior to screening.
The subject is currently receiving, or has received, any investigational agent within the 1 month prior to screening.
The subject has received any blood, blood product, or blood derivative within the 1 month prior to screening.
The subject has received Rituximab within the 3 months before screening
The subject is pregnant or is nursing.
The subject is positive for any of the following at screening: HBsAg, NAT for HCV, NAT for HIV, Antibodies to HCV or HIV 1 or 2.
The subject, at screening, has levels greater than 2.5 times the upper limit of normal, as defined by the central laboratory, of alanine aminotransferase or aspartate aminotransferase.
The subject has a severe renal impairment (defined as serum creatinine greater than 2 times the upper limit of normal or BUN greater than 2.5 times the upper limit of normal for the range of the laboratory doing the analysis); the subject is on dialysis; the subject has a history of acute renal failure.
The subject is known to have abused alcohol, opiates, psychotropic agents, or other chemicals or drugs within the past 12 months.
The subject has a history of deep vein thrombosis (DVT) or thrombotic complications of IGIV therapy.
The subject has any history or sign of hyperviscosity, transient ischemic attack (TIA), stroke, other thromboembolic event, or unstable angina.
The subject suffers from any acute or chronic medical conditions (e.g., renal disease or predisposing conditions for renal disease, coronary artery disease, or protein losing enteropathy) that, in the opinion of the investigator, may interfere with the conduct of the study.
The subject has an acquired medical condition, such as chronic lymphocytic leukemia, lymphoma, multiple myeloma, chronic or recurrent neutropenia (defined as an absolute neutrophil count (ANC) < 1 x 109/L).
The subject has non-controlled arterial hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg).
The subject is anemic (hemoglobin <10 g/dL) at screening.
The subject is unlikely to adhere to the protocol requirements of the study or is likely to be uncooperative..

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00504075

Locations

United States, Florida
Mid Florida Hematology & Oncology	Recruiting
Orange City, Florida, United States, 32763
Contact: Sandy Davis 386-566-3303 swarrington@auafl.com
Principal Investigator: Gregory Ortega, MD
United States, Maryland
Center for Cancer & Blood Disorders	Active, not recruiting
Bethesda, Maryland, United States, 20817
United States, New York
New York Hospital / Cornell University, Division of Pediatrics	Recruiting
New York, New York, United States, 10021
Contact: Jared Levan 212-746-3423 jal2029@med.cornell.edu
Principal Investigator: James B Bussel, MD
Department of Pediatrics, SUNY at Stony Brook	Active, not recruiting
Stony Brook, New York, United States, 11794-8111
United States, Oregon
Oregon Health & Science University	Recruiting
Portland, Oregon, United States, 97239
Contact: Jenifer Borruel Rector, RN BSN CCRC 503-494-7187 borruelr@ohsu.edu
Principal Investigator: Lynn Boshkov, MD

Sponsors and Collaborators

Bio Products Laboratory

Investigators

Principal Investigator:

James B Bussel, MD

New York Presbyterian Hospital

More Information

Additional Information:

Sponsor website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	New York Presbyterian Hospital ( James B Bussel, Principal Investigator )
Study ID Numbers:	GMX02
Study First Received:	July 18, 2007
Last Updated:	July 17, 2009
ClinicalTrials.gov Identifier:	NCT00504075 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bio Products Laboratory:

Idiopathic Thrombocytopenic Purpura
Bleeding disorders
Immune System and Disorders

Study placed in the following topic categories:

Purpura
Autoimmune Diseases
Immunologic Factors
Hematologic Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Hemorrhage
Hemostatic Disorders
Purpura, Thrombocytopenic
Thrombocytopathy

Signs and Symptoms
Antibodies
Thrombocytopenia
Hemorrhagic Disorders
Immunoglobulins, Intravenous
Thrombocytopenic Purpura, Autoimmune
Purpura, Thrombocytopenic, Idiopathic
Rho(D) Immune Globulin
Immunoglobulins

Additional relevant MeSH terms:

Purpura
Skin Manifestations
Autoimmune Diseases
Immunologic Factors
Immune System Diseases
Hematologic Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Physiological Effects of Drugs
Pharmacologic Actions

Purpura, Thrombocytopenic
Signs and Symptoms
Antibodies
Thrombocytopenia
Hemorrhagic Disorders
Immunoglobulins, Intravenous
Purpura, Thrombocytopenic, Idiopathic
Rho(D) Immune Globulin
Immunoglobulins

ClinicalTrials.gov processed this record on September 11, 2009