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Study to Evaluate Safety and Efficacy in Adult Subjects With ITP

NCT ID: NCT02273960

Last Updated: 2019-07-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-17

Study Completion Date

2018-01-22

Brief Summary

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The purpose of this study is to assess the safety and tolerability of BMS-986004 when administered in subjects with ITP.

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Detailed Description

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Conditions

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Immune Thrombocytopenic Purpura

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A: BMS-986004

BMS-986004 solution intravenously (IV) as specified

Group Type EXPERIMENTAL

BMS-986004 75 mg IV

Intervention Type DRUG

BMS-986004 (75 mg) infusion (50 ml) administered in 120 minutes

Arm B: BMS-986004

BMS-986004 solution intravenously as specified

Group Type EXPERIMENTAL

BMS-986004 225 mg IV

Intervention Type DRUG

BMS-986004 (225 mg) infusion (100 ml) administered in 120 minutes

Arm C: BMS-986004

BMS-986004 solution intravenously as specified

Group Type EXPERIMENTAL

BMS-986004 675 mg IV

Intervention Type DRUG

BMS-986004 (675 mg) infusion (100 ml) administered in 120 minutes

Arm D: BMS-986004

BMS-986004 solution intravenously as specified

Group Type EXPERIMENTAL

BMS-986004 1500 mg IV

Intervention Type DRUG

BMS-986004 (1500 mg) infusion (100 ml) administered in 120 minutes

Interventions

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BMS-986004 75 mg IV

BMS-986004 (75 mg) infusion (50 ml) administered in 120 minutes

Intervention Type DRUG

BMS-986004 225 mg IV

BMS-986004 (225 mg) infusion (100 ml) administered in 120 minutes

Intervention Type DRUG

BMS-986004 675 mg IV

BMS-986004 (675 mg) infusion (100 ml) administered in 120 minutes

Intervention Type DRUG

BMS-986004 1500 mg IV

BMS-986004 (1500 mg) infusion (100 ml) administered in 120 minutes

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ≥18 years old, diagnosed with persistent or chronic ITP

Exclusion Criteria

* Secondary immune thrombocytopenia
* Drug induced thrombocytopenia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Univ. Of Southern Calif. /Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Columbus Regional Research Institute

Columbus, Georgia, United States

Site Status

Mass General Hospital

Boston, Massachusetts, United States

Site Status

Rutgers- Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Site Status

Local Institution

Randwick, New South Wales, Australia

Site Status

Local Institution

Brisbane, Queensland, Australia

Site Status

Hamilton Health Sciences/Mc Master Univ Med Ctre

Hamilton, Ontario, Canada

Site Status

Local Institution

Tbilisi, , Georgia

Site Status

Local Institution

Chisinau, , Moldova

Site Status

Oddzial Kliniczny Hematologii i Profilaktyki Chorob Nowotworowych

Chorzów, , Poland

Site Status

Specjalistyczny Gabinet Lekarski Prof. dr hab. Krzysztof Giannopoulos

Lublin, , Poland

Site Status

Local Institution

Warsaw, , Poland

Site Status

Local Institution

Saint Petersburg, , Russia

Site Status

Local Institution

Smolensk, , Russia

Site Status

Local Institution

London, Greater London, United Kingdom

Site Status

Local Institution

Manchester, Greater Manchester, United Kingdom

Site Status

Local Institution

Glasgow, Lanarkshire, United Kingdom

Site Status

Local Institution

London, , United Kingdom

Site Status

Countries

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United States Australia Canada Georgia Moldova Poland Russia United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://www.bmsstudyconnect.com/us/en/home.html

BMS Clinical Trial Information

http://bms.com/studyconnect/Pages/home.aspx

BMS Clinical Trial Patient Recruiting

http://www.bms.com/clinical_trials/Pages/Investigator_inquiry_form.aspx

Investigator Inquiry Form

Other Identifiers

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2014-001429-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IM140-103

Identifier Type: -

Identifier Source: org_study_id

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