| Eligibility |
Inclusion Criteria:
1. Age 18 years or older.
2. Confirmed diagnosis of chronic ITP, according to The American Society of Hematology
(ASH) Guidelines, for at least 6 months and have received one or more prior
conventional treatments for ITP.
3. Patient's platelet count of less than 50,000 per cubic millimeter at enrollment,
platelet count is calculated from the mean of 2 platelet counts taken during the
screening period and that on day1.
4. The subject or his/her legal delegate has signed an informed consent form.
5. Absence of other conditions that, in the opinion of the investigator, could cause
thrombocytopenia.
6. If subjects are currently being treated with corticosteroids, the treatment
regimen/dose must have been stable (±25% total dose/day) for a minimum of 4 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.
7. If subjects are currently being treated with cyclophosphamide, azathioprine or
attenuated androgens, the treatment regimen and dose must have been stable (±25% total
dose/day) for a minimum of 3 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.
8. If a subject is a female of child-bearing potential, she must have a negative result
on a urine-based HCG pregnancy test.
9. If a subject is of child-bearing potential, he/she must practice contraception by
using a method of proven reliability for the duration of the study.
Exclusion Criteria:
1. The subject has a history of any severe or anaphylactic reaction to blood or any
blood-derived product, or any severe reaction to IVIG or any other IgG preparation.
2. The subject is known to be intolerant to any component of the investigational product.
3. The subject has received any live virus vaccine within the last 3 months.
4. The subject has received an IVIG preparation within 1 month prior to screening.
5. The subject is currently receiving, or has received, any investigational agent within
one month prior to screening.
6. The subject has received Rituximab within 3 months before screening.
7. The subject is pregnant or is nursing.
8. The subject is diagnosed of having HIV.
9. The subject, at screening, has levels greater than 2.5 times the upper limit of normal
liver function of alanine aminotransferase or aspartate aminotransferase.
10. 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 range); or the subject is on dialysis.
11. The subject has a history of deep vein thrombosis (DVT) or thrombotic complications.
12. The subject has any history of hyperviscosity, transient ischemic attack (TIA),
stroke, other thromboembolic event, or unstable angina.
13. 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.
14. 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) or has been diagnosed as non-ITP patients.
15. The subject is unlikely to adhere to the protocol requirements of the study or is
likely to be uncooperative.
16. The subject is unwilling or unable to answer the quality of life questionnaires i.e.
the BFI.
17. The subject has undergone splenectomy within 4 weeks prior to screening.
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