Status:
WITHDRAWN
A Study to Investigate Belimumab for the Treatment of Chronic Immune Thrombocytopenia.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Purpura, Thrombocytopaenic, Idiopathic
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Chronic immune thrombocytopenia (ITP) is a longterm disease in which the blood does not clot normally. This is due to a low number of blood cell fragments called platelets. Platelets clot to seal smal...
Eligibility Criteria
Inclusion
- Male or female,18-75 years old
- Chronic ITP for a minimum of 6 months with a platelet count \<75,000/uL at screening and a platelet count \<75,000/uL 2 to 6 months before screening
- Stable either on no treatment or on a stable dose of corticosteroids (10 milligrams(mg)/day prednisone or prednisone equivalent or less) and/or azathioprine (100mg/day or less) for a minimum of 30 days before screening
- Single QTc \<450 milliseconds (msec); or QTc \<480 msec in subjects with Bundle Branch Block
- A female subject is eligible to participate if she is not pregnant or nursing and at least one of the following conditions apply: a. Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea. b.Child-bearing potential and agrees to use one of the contraception methods listed in the protocol
Exclusion
- Diagnosis of ITP is secondary to other conditions
- Treated with any B cell targeted therapy at any time
- Have received any of the following within 364 days prior to Day 0: Abatacept, A biologic investigational agent other than B cell targeted therapy
- Have received any of the following within 180 days prior to Day 0: Intravenous (IV) cyclophosphamide, 3 or more courses of systemic corticosteroids for concomitant conditions
- Have received any of the following within 90 days prior to Day 0: High dose corticosteroid for treatment of ITP, Splenectomy, plasmapheresis
- Have received any of the following within 60 days, 5 half-lives or twice the duration of the biological effect of belimumab before Day 0: A non-biologic investigational agent, any other immunosuppressive/immunomodulatory agent with the exception of azathioprine and corticosteroids, Eltrombopag, romiplostim, any steroid injection
- Have received any of the following within 30 days before Screening: Intravenous immunoglobulin, Corticosteroids greater than 10mg/day (prednisone or prednisone equivalent) or azathioprine more than 100 mg/day, Changes to corticosteroid or azathioprine therapy
- Have received a live vaccine within 30 days before Day 0
- Subject could be at risk of haemorrhage that threatens a vital organ
- History of a major organ transplant or hematopoietic stem cell/marrow transplant
- History of malignant neoplasm within the last 5 years, except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix
- Required management of infections, as follows: Currently on any suppressive therapy for a chronic infection, Hospitalisation for treatment of infection within 60 days before Day 0, Use of parenteral antibiotics within 60 days before Day 0
- Significant unstable or uncontrolled acute or chronic diseases not due to ITP or planned surgical procedure or a history of any other medical disease, laboratory abnormality, or condition that makes the subject unsuitable for the study
- Positive screening Hepatitis C antibody result or Hepatitis B (HB) infection
- Positive test for Human Immunodeficiency Virus (HIV) antibody at screening or historically
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) greater or equal to 2x upper limit of normal (ULN); alkaline phosphatase and bilirubin \>1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin is \<35%)
- IgA deficiency (IgA \<10mg/dL)
- Abnormal lab results
- Lymphocyte count \<500/mm3
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy including a previous anaphylactic reaction to parenteral administration contrast agents, human or murine proteins or monoclonal antibodies
- Evidence of serious suicide risk
- Current drug or alcohol abuse or dependence
- Where participation in the study would result in donation of blood or blood products \>500 mL within a 56 day period
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01440361
Start Date
March 1 2013
End Date
April 1 2015
Last Update
July 28 2014
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