Trials / Completed
CompletedNCT02273960
Study to Evaluate Safety and Efficacy in Adult Subjects With ITP
Open Label, Adaptive Design, Ascending, Multiple-Dose Study to Evaluate Safety and Efficacy of BMS-986004 in Adult Subjects With Primary Immune Thrombocytopenia (ITP)
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the safety and tolerability of BMS-986004 when administered in subjects with ITP.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2014-11-17
- Primary completion
- 2018-01-22
- Completion
- 2018-01-22
- First posted
- 2014-10-24
- Last updated
- 2019-07-16
- Results posted
- 2019-04-01
Locations
20 sites across 8 countries: United States, Australia, Canada, Georgia, Moldova, Poland, Russia, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02273960. Inclusion in this directory is not an endorsement.