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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00504075 |
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Date of registration:
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18/07/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study to Find How Safe and Effective GAMMAPLEX® is in Subjects With Chronic Idiopathic Thrombocytopenic Purpura (ITP)
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Scientific title:
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A Phase III, Multicenter, Open-Label Study To Evaluate the Efficacy and Safety of GAMMAPLEX® in Chronic Idiopathic Thrombocytopenic Purpura |
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Date of first enrolment:
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September 2007 |
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Target sample size:
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35 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00504075 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Argentina
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India
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United States
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Contacts
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Name:
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Tim J Aldwinckle, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bio Products Laboratory |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Idiopathic Thrombocytopenic Purpura
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Intervention(s)
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Biological: Gammaplex, intravenous immunoglobulin
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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.]
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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.]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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