Status:
COMPLETED
Pilot Study of Rituximab for the Treatment of Acute Immune Thrombocytopenic Purpura (ITP)
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Purpura, Thrombocytopenic, Idiopathic
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the feasibility of a randomized, double blind, placebo controlled trial of add-on rituximab for non-splenectomized adults with acute immune thrombocytopenic purp...
Detailed Description
Immune thrombocytopenic purpura (ITP) is an autoimmune disease characterized by severe thrombocytopenia and bleeding. With current standard therapies, adult-onset ITP tends to recur thus exposing pati...
Eligibility Criteria
Inclusion
- Non-splenectomized patients with acute ITP, where "acute ITP" is defined as a platelet count below 30 at the time that standard treatment was recommended by a physician and for which no treatment had been received for the preceding 30 days.
- Must be receiving standard ITP treatment.
Exclusion
- Cardiac arrhythmia.
- Uncontrolled hypertension or inability to hold antihypertensive medications for 12 hours prior to and throughout study drug infusions.
- Known coronary artery disease, angina pectoris or myocardial infarction within the last year.
- Significant pulmonary disease within the last year.
- Stroke, transient ischemic attack or venous thrombosis within the last year.
- Secondary causes of thrombocytopenia (splenomegaly \[palpable spleen or radiologically confirmed \>14 cm\], drug-induced thrombocytopenia, hereditary thrombocytopenia, microangiopathic hemolytic anemia, myelodysplastic syndrome).
- Chronic lymphocytic leukemia or lymphoma.
- Active or metastatic cancer.
- History of hepatitis B or C or HIV.
- Active infection in the 4 weeks before randomization.
- Inherited coagulation factor deficiency.
- Aspirin, aspirin-containing compounds, salicylates, non-steroidal anti-inflammatory medications (NSAIDS) medications, clopidogrel or ticlopidine in the 7 days preceding study drug infusions; vitamin K antagonists (warfarin) in the 3 days preceding study drug infusions; unfractionated heparin or low molecular weight heparin in the 24 hours preceding study drug infusions.
- Elevated INR or prolonged PTT; LDH, serum creatinine, liver function tests (AST/SGOT, ALT/SGPT, alkaline phosphatase, total bilirubin) increased more than 1.5 times upper limit of normal.
- Prior rituximab treatment.
- Unable to schedule 4 weekly study infusions.
- Pregnancy or breastfeeding.
- Known sensitivity to murine proteins, Chinese Hamster Ovary (CHO) cell proteins or to any component of rituximab.
- Participation in another clinical trial.
- Geographic inaccessibility.
- Failure to provide written informed consent.
- Any additional laboratory test result, health related illness or other diagnosis which, in the opinion of the treating physician, may put the subject's health or safety at risk.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00372892
Start Date
September 1 2006
End Date
June 1 2011
Last Update
June 7 2012
Active Locations (7)
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1
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 2A5
2
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 1V7
3
McMaster Univerisity
Hamilton, Ontario, Canada, L8N3Z5
4
Grand River Regional Cancer Centre
Kitchener, Ontario, Canada, N2G 1G3