A Study to Find How Safe and Effective GAMMAPLEX® is in Subjects With Chronic Idiopathic Thrombocytopenic Purpura (ITP)
NCT ID: NCT00504075
Last Updated: 2013-03-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
35 participants
INTERVENTIONAL
2007-09-30
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Gammaplex (intravenous immunoglobulin)
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
No
Sponsors
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Bio Products Laboratory
OTHER
Responsible Party
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Principal Investigators
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Tim J Aldwinckle, MD
Role: PRINCIPAL_INVESTIGATOR
Bio Products Laboratory
Locations
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Mid Florida Hematology & Oncology
Orange City, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Center for Cancer & Blood Disorders
Bethesda, Maryland, United States
New York Hospital / Cornell University, Division of Pediatrics
New York, New York, United States
Department of Pediatrics, SUNY at Stony Brook
Stony Brook, New York, United States
Oregon Health & Science University
Portland, Oregon, United States
Cancer Care Centers of South Texas
San Antonio, Texas, United States
Hospital Churruca
Capital Federal, Buenos Aires, Argentina
Hospital Italiano de La Plata
La Plata, Buenos Aires, Argentina
CER San Juan
San Juan, San Juan Province, Argentina
Instituto de Diagnóstico Hematológico Ambulatorio (IDHEA)
Rosario, Sante Fe, Argentina
I. A. D. T. (Instituto Argentino de Diagnóstico y Tratamiento)
Buenos Aires, , Argentina
Hospital Britanico
Buenos Aires, , Argentina
Centro de Educación Médica e Investigaciones Clinicas Dr. Norberto Quirno (CEMIC)
Buenos Aires, , Argentina
J.R. Vidal Hospital
Corrientes, , Argentina
Hospital Privado de Cordoba
Córdoba, , Argentina
Apollo Hospitals
Hyderabad, Andhra Pradesh, India
Mahavir Hospital
Hyderabad, Andhra Pradesh, India
City Cancer Centre,
Suryarao Pet, Vijayawada, Andhra Pradesh, India
M. S Ramaiah Hospital
Karnataka, Bangalore, India
Vedanta
Ahmedabad, Gujarat, India
Gurukrupa Hospital
Ahmedabad, Gujarat, India
M S Patel Cancer Centre, Shree Krishna Hospital
Gokal Nagar, Karamsad, Gujarat, India
Manipal Hospital
Bangalore, Karnataka, India
Vinaya Hospital & research Centre
Mangalore, Karnataka, India
Kasturba Medical College, Manipal Acunova KMC Research Centre
Mangalore, Karnataka, India
Father Muller Medical College Hospital
Mangalore, Karnataka, India
Deenanath Mangeshkar Hospital
Pune, Maharashtra, India
S.K. Soni Hospital Sect 5
Jaipur, Rajasthan, India
Sir Ganga Ram Hospital
New Delhi, , India
Countries
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References
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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.
Related Links
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Sponsor website
Other Identifiers
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GMX02
Identifier Type: -
Identifier Source: org_study_id
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