A clinical and mechanistic proof of efficacy study with belimumab in chronic immune thrombocytopenia (ITP) patients

GlaxoSmithKline Research & Development Limited0 sites40 target enrollmentMay 25, 2011

ConditionsChronic 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]

DrugsBENLYSTA® (belimumab)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Immune Thrombocytopenia
Sponsor: GlaxoSmithKline Research & Development Limited
Enrollment: 40
Status: Active, not recruiting
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 25, 2011

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GlaxoSmithKline Research & Development Limited

Eligibility Criteria

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

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).