Study to Evaluate Safety and Efficacy in Adult Subjects With ITP

NCT02273960 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2019-07-16

Study results available
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Summary

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

Conditions

  • Immune Thrombocytopenic Purpura

Interventions

DRUG

BMS-986004 75 mg IV

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

DRUG

BMS-986004 225 mg IV

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

DRUG

BMS-986004 675 mg IV

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

DRUG

BMS-986004 1500 mg IV

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

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-17
Primary Completion
2018-01-22
Completion
2018-01-22
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Georgia
  • Moldova
  • Poland
  • Russia
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02273960 on ClinicalTrials.gov