A study to evaluate the efficacy and safety of GAMMAPLEX in patients with chronic Idiopathic Thrombocytopenic Purpura
- Registration Number
- CTRI/2010/091/000016
- Lead Sponsor
- Bio Products Laboratory
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 31
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 ≤20 x 109/L at enrollment. 4) Absence of other conditions that, in the opinion of the
investigator, could cause thrombocytopenia. 5) If subjects are currently being treated with corticosteroids the
treatment regimen/dose must have been stable (for a minimum of 2 weeks before Day 1 infusion). 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. 6) If
subjects are currently being treated with cyclophosphamide, azathioprine or attenuated androgens, the treatment
regimen and dose must have been stable for a minimum of 2 months before infusion on Day 1. However, if there
is any intent to alter the treatment regimen before Day 10, subjects may not be included in the study. 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.
1) The subject has a history of any severe or anaphylactic reaction to blood or any bloodderived
product, or any severe reaction to IGIV 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 prior to Day 1. 4) The subject has received an IGIV preparation within 1 month prior to
Day 1. 5) The subject is currently receiving, or has received, any investigational agent within the 1 month prior to
Day 1. 6) The subject has received any blood, blood product, or blood derivative within the 1 month prior to Day
1. 7) The subject has received Rituximab within the 3 months before Day 1. 8) The subject is pregnant or is
nursing. 9) The subject is positive for any of the following at screening: HBsAg, NAT for HCV, NAT for HIV,Antibodies to HCV or HIV 1 or 2. 10) The subject, at screening, has levels greater than 2.5 times the upper limit of
normal, as defined by the central laboratory, of alanine aminotransferase or aspartate aminotransferase. 11) 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 the range of the laboratory doing the analysis); the
subject is on dialysis; the subject has a history of acute renal failure. 12) The subject is known to have abused
alcohol, opiates, psychotropic agents, or other chemicals or drugs within the past 12 months. 13) The subject has a
history of deep vein thrombosis (DVT) or thrombotic complications of IGIV therapy. 14 The subject has any
history or sign of hyperviscosity, transient ischemic attack (TIA), stroke, other thromboembolic event, or unstable
angina. 15) 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. 16) 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). 17) The subject has non-controlled arterial hypertension (systolic
blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg). 18) The subject is anemic (hemoglobin
<10 g/dL) at screening. 19) The subject is unlikely to adhere to the protocol requirements of the study or is likely
to be uncooperative.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method