Study to evaluate safety and efficacy in adult subjects with ITP

Phase 1

• Conditions: Immune Thrombocytopenia; MedDRA version: 19.1Level: LLTClassification code 10036735Term: Primary thrombocytopeniaSystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2014-001429-33-PL
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-09
• Last Update Posted: 30 April 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

- > or equal to 18 years old, diagnosed with persistent or chronic ITP
- Patients must have received one or more ITP therapies and must have had initially responded to at least one prior ITP therapy
-Subjects have had relapsed ITP
-Platelet count must be less then 30,000/mm3 with no count greate than 35,000/mm3. If the mean of the counts is between 30,000-35,000/mm3, the subject may still be eligible but enrollment will be on a case by case basis and require approval by the Study Director.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 64
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

Exclusion Criteria

- Secondary immune thrombocytopenia
- Drug induced thrombocytopenia
- History of MDS
- Subject exhibit an identifiable alternative cause of their thrombocytopenia.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified