Clinical trial NCT02273960: Study to Evaluate Safety and Efficacy in Adult Subjects With ITP
Official title: Open Label, Adaptive Design, Ascending, Multiple-Dose Study to Evaluate Safety and Efficacy of BMS-986004 in Adult Subjects With Primary Immune Thrombocytopenia (ITP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Immune Thrombocytopenic Purpura
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-10-24
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Short Term and Long Term
timeFrame: Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)
measure: Number of ECG Abnormalities
timeFrame: Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)
measure: Number of Laboratory Abnormalities of Safety Biomarkers: d-Dimer and Thrombin Anti-Thrombin (TAT)
timeFrame: Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long Term)
Secondary outcomes:
measure: Response Rate (RR) of BMS-986004: Short Term and Long Term
timeFrame: Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)
measure: Maximum Observed Serum Concentration (Cmax) of BMS-986004
timeFrame: Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h)
measure: Area Under the Concentration-time Curve in One Dosing Interval [AUC(TAU)] of BMS-986004
timeFrame: Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h)
measure: Trough Observed Serum Concentration (Ctrough) of BMS-986004
timeFrame: Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h)
measure: Total Body Clearance (CLT) of BMS-986004
timeFrame: Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h)
measure: AUC Accumulation Index (AI_AUC) of BMS-986004
timeFrame: Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Univ. Of Southern Calif. /Norris Comprehensive Cancer Center
state: California
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Boston
country: United States
facility: Mass General Hospital
state: Massachusetts
city: New Brunswick
country: United States
facility: Rutgers- Robert Wood Johnson Medical School
state: New Jersey
city: Randwick
country: Australia
facility: Local Institution
state: New South Wales
city: Brisbane
country: Australia
facility: Local Institution
state: Queensland
city: Hamilton
country: Canada
facility: Hamilton Health Sciences/Mc Master Univ Med Ctre
state: Ontario
city: Tbilisi
country: Georgia
facility: Local Institution
city: Chisinau
country: Moldova, Republic of
facility: Local Institution
city: Chorzow
country: Poland
facility: Oddzial Kliniczny Hematologii i Profilaktyki Chorob Nowotworowych
city: Lublin
country: Poland
facility: Specjalistyczny Gabinet Lekarski Prof. dr hab. Krzysztof Giannopoulos
city: Warszawa
country: Poland
facility: Local Institution
city: Saint-Petersburg
country: Russian Federation
facility: Local Institution
city: Smolensk
country: Russian Federation
facility: Local Institution
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: Manchester
country: United Kingdom
facility: Local Institution
state: Greater Manchester
city: Glasgow
country: United Kingdom
facility: Local Institution
state: Lanarkshire
city: London
country: United Kingdom
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: