Health Condition 1: D693- Immune thrombocytopenic purpura
Conditions
Interventions
Intervention1: Human Normal Immunoglobulin (IVIG) for Intravenous use: IVIG is 0.8 - 1 g/kg on day one, which may be repeated once within 3 days (72 hours) of the first dose or 0.4 g/kg daily for two
Sponsors
Bharat Serums and Vaccines Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Confirmed diagnosis of Chronic ITP of atleast 12 months duration Platelet count more than 30,000 per mm3 at screening. absence of other conditions that could cause thrombocytopenia. If subjects are currently being treated with corticosteroids the treatment regimen or dose must have been stable. if subjects are currently being created with cyclophosphamide, azathioprine or attenuated androgens the treatment regimen and dose must have been stable. Splenectomized subjects and both RhD positive and Rh-D negative subject can be included. if subect is a female of child-bearing potential, she must have a negative result on urine-based human chorionic gonadotropin pregnancy test. if 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
Exclusion criteria: Subect has history of any severe or anaphylactic reaction to IVIG or any other IgG preparation or its excipients. Subject has received an IVIG preparation within 1 month prior to screening. Received any blood, blood product, or blood derivative within the 1 month before screening. Received Rituximab within the 3 months before screening. Subject is pregnant or is in a period of lactation Subject has a severe renal impairment Subject is known to have abused alcohol, opiates, psychotropic agents, or other chemicals or drugs with abuse potential in the past 12 months. Subject has a history of deep vein thrombosis (DVT) or thrombotic complications of IVIG therapy subject has any history or sign of hyperviscosity, transient ischemic attack (TIA), stroke, other thromboembolic event, or unstable angina Subject suffers from any acute or chronic medical conditions that may interfere with the conduct of study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number and percentage of subjects with response (R).Timepoint: up to day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| The number and percentage of subjects with CR, LR, and NRTimepoint: up to day 28;Time (in days) from treatment to RTimepoint: up to day 28;Time (in days) from treatment to CRTimepoint: up to day 28;Duration (in days) of RTimepoint: up to day 28;Duration (in days) of CRTimepoint: up to day 28 | — |
Countries
India
Contacts
Public ContactDr Rajan Manguesh
Bharat serums and Vaccines LTd
Outcome results
None listed