Study to evaluate safety and efficacy in adult subjects with ITP

Phase 1

• Conditions: Immune Thrombocytopenia; MedDRA version: 19.0 Level: LLT Classification code 10036735 Term: Primary thrombocytopenia System Organ Class: 100000004851; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-07
• Study Completion: 2018-01-22
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 26

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The purpose of this study is to assess the safety and tolerability of BMS-986004 when administered in subjects with ITP. ;Secondary Objective: The secondary endpoints include response rate, summary of PK parameters and anti-drug antibody to BMS-986004;Primary end point(s): Frequency of worst grade of adverse events (AEs), worst grade of serious adverse events (SAEs), incidence of adverse events leading to discontinuations, and deaths.;Timepoint(s) of evaluation of this end point: From Day 1 till Day 141

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary endpoints include response rate, summary of PK parameters and anti-drug antibody to BMS-986004;Timepoint(s) of evaluation of this end point: Day 1 to Day 141