Status:
COMPLETED
Rituximab as Second Line Treatment for ITP
Lead Sponsor:
Ostfold Hospital Trust
Collaborating Sponsors:
Oslo University Hospital
South-Eastern Regional Health Authority
Conditions:
Immune Thrombocytopenia (ITP)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Immune thrombocytopenic purpura (ITP) is an autoimmune disorder characterized thrombocytopenia. Splenectomy is the standard treatment for patients who fails the first-line treatment: corticosteroid. ...
Detailed Description
ITP is an autoimmune disorder characterized by formation of autoantibodies against platelet antigens leading to premature platelet destruction and persistent thrombocytopenia often resulting in bleedi...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- ITP with platelet count \<30 x 109 /l after 2 weeks of treatment with prednisolon or during prednisolon tapering period i.e. from week three of prednisolon initiation. Patients with platelet count between 30 -50 are eligible if a higher platelet count is considered necessary, because of : concomitant medical illness predisposing to bleeding (hypertension, GI bleeding, bleeding diathesis, previous history of bleeding) concomitant medical condition requiring platelet blocking agents/ anticoagulation, persistent bleeding despite platelets \> 30 x 109 /l, prior to surgery, or because of other patient related factors necessitating higher platelet count as occupation, hobby, psychological intolerability.
- Subject is \>18 years
- Subject has signed and dated written informed consent.
- Subject is able to understand and comply with protocol requirements and instructions, and intends to complete the study as planned.
- Females in fertile age should express willingness for use of contraceptive means for 6 months following the administration of the study drugs.
- Exclusion criteria:
- Previous splenectomy, chemotherapy, treatment with anti-D Ig, rituximab, or immune-suppressive treatments other than corticosteroids, Dapsone or Danazol
- Underlying malignancy or previous history of malignancy in the past 5 years (except skin carcinoma)
- Pregnancy and lactation
- Not willing to participate in the study
- Expected survival of \< 2 years
- Known intolerance to murine antibodies
- Females in child-bearing age not willing to use contraception for 6 months
- HIV-positive/AIDS-, Hepatitis -B virus positive- or Hepatitis -C virus positive
- Patients with a definite Systemic Lupus Erythematosus (SLE) (\> 4 of the American College of Rheumatology Criteria)
- Patients currently involved in another clinical trial with evaluation of drug treatment
- Bacterial infections, viral infections, fungal infections, myco-bacterial infections (excluding fungal infections) or other evolutive infections or any other infections episode requiring hospitalisation or treatment with an antibiotics 4 weeks before selection for IV route or within 2 weeks before selection for oral route
- History of soft tissue, bone or joint infections (fascitis, abscess, osteomyelitis, septic arthritis) during the last year prior to inclusion in the study
- Medical history of relapsing or chronic severe infectious diseases or any other underlying pathology predisposing to serious infections
- Known Primary or secondary immune deficiency syndromes
- Administration of a living vaccine within 4 weeks preceding the inclusion in the study -16- Previous treatment with any lymphocytes depleting medication (e.g.: MabCampath®)
- 17- Previous treatment with inhibitors of leucocytes transmigration (e.g.: Tysabri®) 18- Known intolerance to human monoclonal antibodies 19- Known severe chronic pulmonary obstructive Disease (FEV \< 50% or functional dyspnoea grade 3) 20- Known congestive heart failure NYHA (New York Heart Association classification of heart failure) class III and IV 21- Recent episode (\<6 months) of acute coronary syndrome.
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00344149
Start Date
June 1 2006
End Date
March 1 2014
Last Update
March 26 2014
Active Locations (1)
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1
Østfold Hospital Trust in Fredrikstad and National hospital in Oslo
Fredrikstad and Oslo, Norway, 1603