A Study to Find How Safe and Effective GAMMAPLEX® is in Subjects With Chronic Idiopathic Thrombocytopenic Purpura (ITP)
A Phase III, Multicenter, Open-Label Study To Evaluate the Efficacy and Safety of GAMMAPLEX® in Chronic Idiopathic Thrombocytopenic Purpura
1 other identifier
interventional
35
3 countries
30
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2007
Typical duration for phase_3
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2007
CompletedFirst Posted
Study publicly available on registry
July 19, 2007
CompletedStudy Start
First participant enrolled
September 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
June 6, 2012
CompletedMarch 1, 2013
February 1, 2013
3.9 years
July 18, 2007
May 4, 2012
February 26, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Number of Subjects With Chronic ITP Treated With Gammaplex Whose Platelet Count Reached a Threshold of 50 x 10^9/L.
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.
9 days
Secondary Outcomes (2)
The Safety of GAMMAPLEX at the Dosage Used in This Study.
AEs were documented from the date the informed consent form was signed until the End of Study visit on Day 90.
Duration of Time That the Platelet Count of Subjects With Chronic ITP Treated With Gammaplex Remained ≥ 50 x 10^9/L.
Days 1, 2, 3, 5, 9, 14, 21, 32.
Study Arms (1)
Gammaplex (intravenous immunoglobulin)
EXPERIMENTALInterventions
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 Criteria
You may qualify if:
- Males and females aged between 18 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 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.
- \) 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.
- \) 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.
You may not qualify if:
- 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.
- Intolerance to any component of the investigational product.
- Received any live virus vaccine within the last 3 months prior to Day1.
- Received an IGIV preparation within 1 month prior to Day 1.
- Were currently receiving, or has received, any investigational agent within the 1 month prior to Day 1.
- Received any blood, blood product, or blood derivative within the 1 month prior to Day 1.
- Received Rituximab within the 3 months before Day 1.
- Pregnant or nursing.
- Tested positive for any of the following at screening: HBsAg, NAT for HCV, NAT for HIV, Antibodies to HCV or HIV 1 or 2.
- 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.
- 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.
- Known to have abused alcohol, opiates, psychotropic agents, or other chemicals or drugs within the past 12 months.
- History of deep vein thrombosis (DVT) or thrombotic complications of IGIV therapy.
- Any history or sign of hyperviscosity, transient ischemic attack (TIA), stroke, other thromboembolic event, or unstable angina.
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Mid Florida Hematology & Oncology
Orange City, Florida, 32763, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Center for Cancer & Blood Disorders
Bethesda, Maryland, 20817, United States
New York Hospital / Cornell University, Division of Pediatrics
New York, New York, 10021, United States
Department of Pediatrics, SUNY at Stony Brook
Stony Brook, New York, 11794-8111, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Cancer Care Centers of South Texas
San Antonio, Texas, 78229, United States
Hospital Churruca
Capital Federal, Buenos Aires, C1437JCP, Argentina
Hospital Italiano de La Plata
La Plata, Buenos Aires, B1900AXU, Argentina
CER San Juan
San Juan, San Juan Province, 5400, Argentina
Instituto de Diagnóstico Hematológico Ambulatorio (IDHEA)
Rosario, Sante Fe, S2000JKR, Argentina
I. A. D. T. (Instituto Argentino de Diagnóstico y Tratamiento)
Buenos Aires, C1122AAL, Argentina
Hospital Britanico
Buenos Aires, C1280AEB, Argentina
Centro de Educación Médica e Investigaciones Clinicas Dr. Norberto Quirno (CEMIC)
Buenos Aires, C1431FWO, Argentina
J.R. Vidal Hospital
Corrientes, Argentina
Hospital Privado de Cordoba
Córdoba, X5016KEH, Argentina
Apollo Hospitals
Hyderabad, Andhra Pradesh, 500003, India
Mahavir Hospital
Hyderabad, Andhra Pradesh, 500054, India
City Cancer Centre,
Suryarao Pet, Vijayawada, Andhra Pradesh, 520002, India
M. S Ramaiah Hospital
Karnataka, Bangalore, 560054, India
Vedanta
Ahmedabad, Gujarat, 380009, India
Gurukrupa Hospital
Ahmedabad, Gujarat, 380061, India
M S Patel Cancer Centre, Shree Krishna Hospital
Gokal Nagar, Karamsad, Gujarat, 388325, India
Manipal Hospital
Bangalore, Karnataka, 560017, India
Vinaya Hospital & research Centre
Mangalore, Karnataka, 5750003, India
Kasturba Medical College, Manipal Acunova KMC Research Centre
Mangalore, Karnataka, 575001, India
Father Muller Medical College Hospital
Mangalore, Karnataka, 575002, India
Deenanath Mangeshkar Hospital
Pune, Maharashtra, 411004, India
S.K. Soni Hospital Sect 5
Jaipur, Rajasthan, 300201, India
Sir Ganga Ram Hospital
New Delhi, 110060, India
Related Publications (1)
Dash CH, Gillanders KR, Stratford Bobbitt ME, Gascoigne EW, Leach SJ. Safety and efficacy of Gammaplex(R) in idiopathic thrombocytopenic purpura (ClinicalTrials.gov--NCT00504075). PLoS One. 2014 Jun 3;9(6):e96600. doi: 10.1371/journal.pone.0096600. eCollection 2014.
PMID: 24892422DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Tim Aldwinckle, MD
- Organization
- Bio Products Laboratory Limited
Study Officials
- PRINCIPAL INVESTIGATOR
Tim J Aldwinckle, MD
Bio Products Laboratory
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2007
First Posted
July 19, 2007
Study Start
September 1, 2007
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
March 1, 2013
Results First Posted
June 6, 2012
Record last verified: 2013-02