Status:
COMPLETED
A Randomized Study of IVIG vs. IVIG With High Dose Methylprednisolone in Childhood ITP.
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
Bayer
Conditions:
Immune Thrombocytopenic Purpura
Eligibility:
All Genders
1-17 years
Phase:
PHASE3
Brief Summary
Childhood immune thrombocytopenia purpura (ITP) is a disorder characterized by the production of antibodies against platelets, resulting in enhanced destruction of platelets. Most children with ITP pr...
Detailed Description
Rarely children with immune thrombocytopenia purpura (ITP) can present with severe or life-threatening bleeding. In these cases it is very important that the platelet count be raised as quickly as pos...
Eligibility Criteria
Inclusion
- ages 1-17 yr. followed at participating centers
- diagnosed with primary ITP
- present with a PC \< 20 x 10\^9/L
- patient and attending physician have decided on treatment of ITP
Exclusion
- initial presentation with ITP
- splenectomy
- life-threatening hemorrhage e.g. proven or suspected intracranial hemorrhage (ICH), major gastrointestinal hemorrhage with cardiorespiratory decompensation
- organ-threatening hemorrhage e.g. hemorrhage into the eye
- contraindication to IVIG ( renal disease with creatinine \> x 2 upper list of normal )
- contraindication of IV methylprednisolone ( diabetes mellitus, hypertension, peptic ulceration )
- prior failure to attain a PC level over 50 X 109 within 2 weeks of treatment with IVIG of 0.8 to 1 g/kg or IV methyl-prednisolone (max 1 gram ) within 6 months prior to study entry
- co-existing situations that could affect platelet response to therapy e.g. sepsis, fever \> 38.5°C ( orally or equivalent), splenomegaly (spleen tip \> 2 cm below costal margin), Disseminated Intravascular Coagulation (DIC) - defined by a fibrinogen level \< 1.0 g/dL and elevated D-dimer levels, surgery
- pregnancy (a mandatory urine pregnancy test will be obtained on all post-pubescent female patients). Such patients can only be eligible once the urine pregnancy test results are confirmed to be negative.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00376077
Start Date
August 1 2005
End Date
April 1 2016
Last Update
May 9 2016
Active Locations (1)
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1
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8