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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bio Products Laboratory
ClinicalTrials.gov Identifier:
NCT00504075
First received: July 18, 2007
Last updated: February 26, 2013
Last verified: February 2013
  Purpose

To determine if GAMMAPLEX raises the platelet count of subjects with chronic ITP to a threshold of 50 x 109/L, similar to that of published response >60%. Also to assess the safety of GAMMAPLEX and determine if platelet counts are maintained at 50 x 109/L in subjects with chronic ITP for.


Condition Intervention Phase
Chronic Idiopathic Thrombocytopenic Purpura
Biological: Gammaplex, intravenous immunoglobulin
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


Further study details as provided by Bio Products Laboratory:

Primary Outcome Measures:
  • The Number of Subjects With Chronic ITP Treated With Gammaplex Whose Platelet Count Reached a Threshold of 50 x 10^9/L. [ Time Frame: 9 days ] [ Designated as safety issue: No ]
    The number of subjects with chronic ITP treated following treatment with Gammaplex who attained a platelet count of ≥ 50 x 10^9/L by Day 9.


Secondary Outcome Measures:
  • The Safety of GAMMAPLEX at the Dosage Used in This Study. [ Time Frame: AEs were documented from the date the informed consent form was signed until the End of Study visit on Day 90. ] [ Designated as safety issue: Yes ]

    The safety variables used to assess safety were the following:

    • Adverse events

      • The number and percent of infusions with at least 1 adverse event(AE) that occurs during an infusion or within 72 hours after the infusion stops
      • Nature, severity, and frequency of AEs
      • Suspected unexpected serious adverse reactions (SUSARs)
    • Vital signs
    • Clinical laboratory tests and Direct Coombs' Test
    • Transmission of viruses
    • Physical examination

  • Duration of Time That the Platelet Count of Subjects With Chronic ITP Treated With Gammaplex Remained ≥ 50 x 10^9/L. [ Time Frame: Days 1, 2, 3, 5, 9, 14, 21, 32. ] [ Designated as safety issue: No ]
    Blood samples were collected to measure platelet counts and the duration of time for which the platelet count remained ≥50 x 10^9/L was measured.


Enrollment: 35
Study Start Date: September 2007
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gammaplex (intravenous immunoglobulin) Biological: Gammaplex, intravenous immunoglobulin

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.

Other Name: Gammaplex

Detailed Description:

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 published response >60%. 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 published data.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females aged between 18 and 70 years.
  2. Confirmed diagnosis of chronic ITP of at least 6 months duration.
  3. Platelet count of less than or equal to 20 x 10 9/L at enrollment.
  4. Absence of other conditions that, in the opinion of the investigator, could cause thrombocytopenia.
  5. If subjects were treated with corticosteroids the treatment regimen/dose must have been stable (for a minimum of 2 weeks before screening). The dose of corticosteriod or other immunosuppressant should have remained constant until Day 32. 6) If subjects were being treated with cyclophosphamide, azathioprine or attenuated androgens, the treatment regimen and dose must have been stable for a minimum of 2 months before Day 1. The dose of corticosteriod or other immunosuppressant should have remained constant until Day 32. 7) Splenectomized subjects and both Rh(D)+ and Rh(D)- subjects may be included.

8) The subject has signed an informed consent form (subjects must be at least 18 years old), and/or the subject's legal guardian has signed the informed consent form if indicated 9) If a subject is a female of child-bearing potential, she must have a negative result on a urine-based HCG pregnancy test.

10) 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:

  1. 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.
  2. Intolerance to any component of the investigational product.
  3. Received any live virus vaccine within the last 3 months prior to Day1.
  4. Received an IGIV preparation within 1 month prior to Day 1.
  5. Were currently receiving, or has received, any investigational agent within the 1 month prior to Day 1.
  6. Received any blood, blood product, or blood derivative within the 1 month prior to Day 1.
  7. Received Rituximab within the 3 months before Day 1.
  8. Pregnant or nursing.
  9. Tested positive for any of the following at screening: HBsAg, NAT for HCV, NAT for HIV, Antibodies to HCV or HIV 1 or 2.
  10. Had levels greater than 2.5 times the upper limit of normal at screening, as defined by the central laboratory, of alanine aminotransferase or aspartate aminotransferase.
  11. Had 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); on dialysis; a history of acute renal failure.
  12. Known to have abused alcohol, opiates, psychotropic agents, or other chemicals or drugs within the past 12 months.
  13. History of deep vein thrombosis (DVT) or thrombotic complications of IGIV therapy.
  14. Any history or sign of hyperviscosity, transient ischemic attack (TIA), stroke, other thromboembolic event, or unstable angina.
  15. Suffered 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.
  16. 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).
  17. Non-controlled arterial hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg).
  18. Anemic (hemoglobin <10 g/dL) at screening.
  19. Unlikely to adhere to the protocol requirements of the study or is likely to be uncooperative.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Florida
Mid Florida Hematology & Oncology
Orange City, Florida, United States, 32763
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Maryland
Center for Cancer & Blood Disorders
Bethesda, Maryland, United States, 20817
United States, New York
New York Hospital / Cornell University, Division of Pediatrics
New York, New York, United States, 10021
Department of Pediatrics, SUNY at Stony Brook
Stony Brook, New York, United States, 11794-8111
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Texas
Cancer Care Centers of South Texas
San Antonio, Texas, United States, 78229
Argentina
Hospital Churruca
Capital Federal, Buenos Aires, Argentina, C1437JCP
Hospital Italiano de La Plata
La Plata, Buenos Aires, Argentina, B1900AXU
Instituto de Diagnóstico Hematológico Ambulatorio (IDHEA)
Rosario, Sante Fe, Argentina, S2000JKR
Hospital Britanico
Buenos Aires, Argentina, C1280AEB
I. A. D. T. (Instituto Argentino de Diagnóstico y Tratamiento)
Buenos Aires, Argentina, C1122AAL
Centro de Educación Médica e Investigaciones Clinicas Dr. Norberto Quirno (CEMIC)
Buenos Aires, Argentina, C1431FWO
Hospital Privado de Cordoba
Cordoba, Argentina, X5016KEH
J.R. Vidal Hospital
Corrientes, Argentina
CER San Juan
San Juan, Argentina, 5400
India
Apollo Hospitals
Hyderabad, Andhra Pradesh, India, 500003
Mahavir Hospital
Hyderabad, Andhra Pradesh, India, 500054
City Cancer Centre,
Suryarao pet, Vijayawada, Andhra Pradesh, India, 520002
M. S Ramaiah Hospital
Karnataka, Bangalore, India, 560054
Vedanta
Ahmedabad, Gujarat, India, 380009
Gurukrupa Hospital
Ahmedabad, Gujarat, India, 380061
M S Patel Cancer Centre, Shree Krishna Hospital
Gokal Nagar, Karamsad, Gujarat, India, 388325
Manipal Hospital
Bangalore, Karnataka, India, 560017
Vinaya Hospital & research Centre
Mangalore, Karnataka, India, 5750003
Kasturba Medical College, Manipal Acunova KMC Research Centre
Mangalore, Karnataka, India, 575001
Father Muller Medical College Hospital
Mangalore, Karnataka, India, 575002
Deenanath Mangeshkar Hospital
Pune, Maharashtra, India, 411004
S.K. Soni Hospital Sect 5
Jaipur, Rajasthan, India, 300201
Sir Ganga Ram Hospital
New Delhi, India, 110060
Sponsors and Collaborators
Bio Products Laboratory
Investigators
Principal Investigator: Tim J Aldwinckle, MD Bio Products Laboratory
  More Information

Additional Information:
No publications provided by Bio Products Laboratory

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bio Products Laboratory
ClinicalTrials.gov Identifier: NCT00504075     History of Changes
Other Study ID Numbers: GMX02
Study First Received: July 18, 2007
Results First Received: May 4, 2012
Last Updated: February 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bio Products Laboratory:
Idiopathic Thrombocytopenic Purpura
Bleeding disorders
Immune System and Disorders

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014