Phase 2
Completed N=26
Study to Evaluate Safety and Efficacy in Adult Subjects With ITP
Immune Thrombocytopenic Purpura
Source: ClinicalTrials.gov NCT02273960 ↗
Enrolled (actual)
26
Serious AEs
11.5%
Results posted
Apr 2019
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Short Term and Long Term — 1; 5; 5; 9 Participants
Summary
The purpose of this study is to assess the safety and tolerability of BMS-986004 when administered in subjects with ITP.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Short Term and Long Term |
1; 5; 5; 9; 0; 0 | — |
| PRIMARY Number of ECG Abnormalities |
1; 3; 2; 3; 1; 2 | — |
| PRIMARY Number of Laboratory Abnormalities of Safety Biomarkers: d-Dimer and Thrombin Anti-Thrombin (TAT) |
56; 81; 60; 106; 12; 14 | — |
| SECONDARY Response Rate (RR) of BMS-986004: Short Term and Long Term |
0.2; 0.3; 0.4; 0.4; 0; 0 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) of BMS-986004 |
19353.5; 59478.8; 177706.3; 296561.9; 62469.8; 186981.0 | — |
| SECONDARY Area Under the Concentration-time Curve in One Dosing Interval [AUC(TAU)] of BMS-986004 |
915500; 3445000; 11440000; 18370000; 4408000; 11460000 | — |
| SECONDARY Trough Observed Serum Concentration (Ctrough) of BMS-986004 |
978.0; 2373.0; 7556.4; 15282.5; 1011.4; 3157.7 | — |
| SECONDARY Total Body Clearance (CLT) of BMS-986004 |
0.0789; 0.0618; 0.0561; 0.0860; 0.0716; 0.0611 | — |
| SECONDARY AUC Accumulation Index (AI_AUC) of BMS-986004 |
1.7996 | — |
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- ≥18 years old, diagnosed with persistent or chronic ITP
Exclusion Criteria
- Secondary immune thrombocytopenia
- Drug induced thrombocytopenia
Data sourced from ClinicalTrials.gov (NCT02273960). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.