A study to investigate belimumab for the treatment of chronic immune thrombocytopenia

Conditions: Chronic Immune Thrombocytopenia
MedDRA version: 14.1Level: LLTClassification code 10051057Term: Idiopathic thrombocytopeniaSystem Organ Class: 10005329 - Blood and lymphatic system disorders
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Registration Number: EUCTR2011-000241-21-GB

Lead Sponsor: GlaxoSmithKline Research & Development Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

1.Age & gender: Male or female between 18 and 75 years of age inclusive, at the time of signing the informed consent
2. Disease severity: Diagnosis of chronic ITP for a minimum of 6 months with a platelet count of =75,000/µL at screening and a historical platelet count of =75,000/µL 2 to 6 months prior to screening.
3. ITP treatment: ITP patients stable either on no treatment or on a stable dose of corticosteroids (10mg/day prednisone or prednisone equivalent or less) and/or azathioprine (100mg/day or less) for a minimum of 30 days before screening.
4. ECG: Single QTc, < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
5. Female subject: 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 [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<147 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in Section 8.1.1 if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
b. Child-bearing potential and agrees to use one of the contraception methods listed in Section 8.1.1 for one month (2 weeks for abstinence) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 16 weeks after the last dose.
6. Informed consent: Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1. Secondary ITP: If the diagnosis of ITP is secondary to other conditions.
2. B-cell Prior Therapy: Have received treatment with any B cell targeted therapy at any time.
3. 364 Day Prior Therapy: Have received any of the following within 364 days prior to Day 0:
• Abatacept.
• A biologic investigational agent other than B cell targeted therapy.
4. 180 Day Prior 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 (eg, asthma, atopic dermatitis. Topical or inhaled steroids are permitted).
5. 90 Day Prior Therapy: Have received any of the following within 90 days prior to Day 0:
• High dose corticosteroid for treatment of ITP (> 100 mg/day prednisone or equivalent).
• Splenectomy, plasmapheresis.
6. 60 Day Prior Therapy: Have received any of the following within 60 days, 5 halflives or twice the duration of the biological effect of the investigational product (whichever is longer) prior to Day 0:
• A non-biologic investigational agent.
• Any other immunosuppressive/immunomodulatory agent with the exception of azathioprine and corticosteroids.
• Eltrombopag, romiplostim.
• Any steroid injection.
Note: Inhaled steroids and Topical immunosuppressive agents are allowed.
7. 30 Day Prior to Screening Therapy: Have received any of the following within 30 days prior to Screening:
• Intravenous immunoglobulin.
• Corticosteroids greater than 10mg/day or azathioprine more than 100 mg/day.
• Changes to corticosteroid or azathioprine therapy.
8. 30 Day Prior Therapy: Have received any of the following within 30 days prior to Day 0:
• A live vaccine.
9. Haemorrhage: Disease status where, in the opinion of the investigator, the subject could be at risk of haemorrhage that threatens a vital organ.
10. Transplantation: Have a history of a major organ transplant or hematopoietic stem cell/marrow transplant.
11. Cancer: Have a history of malignant neoplasm within the last 5 years, except for adequately treated cancers of the skin or carcinoma in situ of the uterine cervix.
12. Acute or chronic infection: Have required management of acute or chronic infections, as follows:
• Currently on any suppressive therapy for a chronic infection
• Hospitalisation for treatment of infection within 60 days prior to Day 0.
• Use of parenteral antibiotics within 60 days prior to Day 0.
13. Other diseases/conditions: Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to ITP which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk.
or
Have a planned surgical procedure or a history of any other medical disease, laboratory abnormality, or condition that, in the opinion of the investigator, makes the subject unsuitable for the study.
14. Hepatitis: A positive screening Hepatitis C antibody result or serologic evidence of
Hepatitis B (HB) infection based on the results of testing for HBsAg, anti-HBc and anti-HBs as follows:
• Patients positive for HBsAg are excluded.
• Patients negative for HBsAg and anti-HBc antibody but positive for anti-HBs antibody and with no history of Hepatitis B vaccination are excluded.
• Patients negative for HBsAg but positive for both anti-HBc and anti-HBs
antibodies are excluded.
• Patients negative for HBsAg and anti-HBs antibody but positive for anti-HBc antibody are e

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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