A Study to Find How Safe and Effective GAMMAPLEX® is in Subjects With Chronic Idiopathic Thrombocytopenic Purpura (ITP)
Condition: Chronic Idiopathic Thrombocytopenic Purpura
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Intervention: Gammaplex, intravenous immunoglobulin
Intervention description: Dosage form: Gammaplex® is a sterile liquid of 5 % w/v normal immunoglobulin. Gammaplex® contains 5 g/100 mL of human normal immunoglobulin (i.e. 50 g/L, of which virtually 100% is IgG).
The first course of GAMMAPLEX will be administered as an intravenous infusion of 1 g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen may be administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies; gamma-Globulins; Rho(D) Immune Globulin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Idiopathic Thrombocytopenic Purpura; Bleeding disorders; Immune System and Disorders

Summary:

      To determine if GAMMAPLEX raises the platelet count of subjects with chronic ITP to a
      threshold of 50 x 109/L, similar to that of published response >60%. Also to assess the
      safety of GAMMAPLEX and determine if platelet counts are maintained at 50 x 109/L in subjects
      with chronic ITP for.
    

Eligibility criteria:

        Inclusion Criteria:

          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 of less than or equal to 20 x 10 9/L at enrollment.

          4. Absence of other conditions that, in the opinion of the investigator, could cause
             thrombocytopenia.

          5. If subjects were treated with corticosteroids the treatment regimen/dose must have
             been stable (for a minimum of 2 weeks before screening). The dose of corticosteriod or
             other immunosuppressant should have remained constant until Day 32. 6) If subjects
             were being treated with cyclophosphamide, azathioprine or attenuated androgens, the
             treatment regimen and dose must have been stable for a minimum of 2 months before Day
             1. The dose of corticosteriod or other immunosuppressant should have remained constant
             until Day 32. 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.

        Exclusion Criteria:

          1. A history of any severe or anaphylactic reaction to blood or any blood-derived
             product, or any severe reaction to IGIV or any other IgG preparation.

          2. Intolerance to any component of the investigational product.

          3. Received any live virus vaccine within the last 3 months prior to Day1.

          4. Received an IGIV preparation within 1 month prior to Day 1.

          5. Were currently receiving, or has received, any investigational agent within the 1
             month prior to Day 1.

          6. Received any blood, blood product, or blood derivative within the 1 month prior to Day
             1.

          7. Received Rituximab within the 3 months before Day 1.

          8. Pregnant or nursing.

          9. Tested positive for any of the following at screening: HBsAg, NAT for HCV, NAT for
             HIV, Antibodies to HCV or HIV 1 or 2.

         10. Had levels greater than 2.5 times the upper limit of normal at screening, as defined
             by the central laboratory, of alanine aminotransferase or aspartate aminotransferase.

         11. Had 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); on dialysis; a history of acute renal
             failure.

         12. Known to have abused alcohol, opiates, psychotropic agents, or other chemicals or
             drugs within the past 12 months.

         13. History of deep vein thrombosis (DVT) or thrombotic complications of IGIV therapy.

         14. Any history or sign of hyperviscosity, transient ischemic attack (TIA), stroke, other
             thromboembolic event, or unstable angina.

         15. Suffered 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. 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. Non-controlled arterial hypertension (systolic blood pressure >160 mmHg and/or
             diastolic blood pressure >90 mmHg).

         18. Anemic (hemoglobin <10 g/dL) at screening.

         19. Unlikely to adhere to the protocol requirements of the study or is likely to be
             uncooperative.