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Study to Evaluate Safety and Efficacy in Adult Subjects With ITP (ITP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02273960
Recruitment Status : Completed
First Posted : October 24, 2014
Results First Posted : April 1, 2019
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenic Purpura Drug: BMS-986004 75 mg IV Drug: BMS-986004 225 mg IV Drug: BMS-986004 675 mg IV Drug: BMS-986004 1500 mg IV Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : November 17, 2014
Actual Primary Completion Date : January 22, 2018
Actual Study Completion Date : January 22, 2018


Arm Intervention/treatment
Experimental: Arm A: BMS-986004
BMS-986004 solution intravenously (IV) as specified
Drug: BMS-986004 75 mg IV
BMS-986004 (75 mg) infusion (50 ml) administered in 120 minutes

Experimental: Arm B: BMS-986004
BMS-986004 solution intravenously as specified
Drug: BMS-986004 225 mg IV
BMS-986004 (225 mg) infusion (100 ml) administered in 120 minutes

Experimental: Arm C: BMS-986004
BMS-986004 solution intravenously as specified
Drug: BMS-986004 675 mg IV
BMS-986004 (675 mg) infusion (100 ml) administered in 120 minutes

Experimental: Arm D: BMS-986004
BMS-986004 solution intravenously as specified
Drug: BMS-986004 1500 mg IV
BMS-986004 (1500 mg) infusion (100 ml) administered in 120 minutes




Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Short Term and Long Term [ Time Frame: Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term) ]
    The primary objective to establish safety was measured by the primary endpoints of AEs and SAEs for both Short term and Long term periods

  2. Number of ECG Abnormalities [ Time Frame: Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term) ]
    The primary objective to establish safety was measured by investigator identified Electrocardiogram Abnormalities for both Short term and Long term periods. ECG parameters included heart rate, PR interval, QRS interval, and QTcF interval (QT interval corrected for heart rate)

  3. Number of Laboratory Abnormalities of Safety Biomarkers: d-Dimer and Thrombin Anti-Thrombin (TAT) [ Time Frame: Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long Term) ]
    D-dimer and thrombin antithrombin (TAT) in plasma were quantified as measures of thromboembolism risk. D-dimer was evaluated by Enzyme linked immune sorbent assay (ELISA) method (D-dimer reference range 0-0.63 micrograms/milliliters fibrinogen equivalent units [mcg/ml FEU]). TAT reference range 0-4.1 ng/ml.


Secondary Outcome Measures :
  1. Response Rate (RR) of BMS-986004: Short Term and Long Term [ Time Frame: Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term) ]
    Overall Response Rate (ORR) was defined as the proportion of participants who achieved a complete response (CR) or response (R). CR was defined as platelet count ≥ 100,000/mm3 and absence of bleeding. R was defined as platelet count ≥ 30,000/mm3 and at least 2-fold increase from the baseline count and absence of bleeding.

  2. Maximum Observed Serum Concentration (Cmax) of BMS-986004 [ Time Frame: 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) ]
    Pharmacokinetic parameter (Cmax) of BMS-986004, derived from serum concentration versus time. who have adequate PK profiles. On study Day 57, non-responders in each treatment group other than the 1500 mg group were dose escalated to the starting dose of the next higher treatment group.

  3. Area Under the Concentration-time Curve in One Dosing Interval [AUC(TAU)] of BMS-986004 [ Time Frame: 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) ]
    Pharmacokinetics of BMS-986004 were derived from serum concentration versus time data. AUC(TAU) = Area under the concentration-time curve in one dosing interval. On study Day 57, non-responders in each treatment group other than the 1500 mg group were dose escalated to the starting dose of the next higher treatment group.

  4. Trough Observed Serum Concentration (Ctrough) of BMS-986004 [ Time Frame: 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) ]
    Pharmacokinetics of BMS-986004 were derived from serum concentration versus time data. Ctrough = Trough observed serum concentration. On study Day 57, non-responders in each treatment group other than the 1500 mg group were dose escalated to the starting dose of the next higher treatment group.

  5. Total Body Clearance (CLT) of BMS-986004 [ Time Frame: 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) ]
    Pharmacokinetics of BMS-986004 were derived from serum concentration versus time data. On study Day 57, non-responders in each treatment group other than the 1500 mg group were dose escalated to the starting dose of the next higher treatment group.

  6. AUC Accumulation Index (AI_AUC) of BMS-986004 [ Time Frame: 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) ]
    AUC accumulation index (AI_AUC) = ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose of BMS-986004. On study Day 57, non-responders in each treatment group other than the 1500 mg group were dose escalated to the starting dose of the next higher treatment group.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02273960


Locations
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United States, California
Univ. Of Southern Calif. /Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Columbus Regional Research Institute
Columbus, Georgia, United States, 31904
United States, Massachusetts
Mass General Hospital
Boston, Massachusetts, United States, 02114
United States, New Jersey
Rutgers- Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Australia, New South Wales
Local Institution
Randwick, New South Wales, Australia, 2031
Australia, Queensland
Local Institution
Brisbane, Queensland, Australia, 4102
Canada, Ontario
Hamilton Health Sciences/Mc Master Univ Med Ctre
Hamilton, Ontario, Canada, L8S 4K1
Georgia
Local Institution
Tbilisi, Georgia, 0112
Moldova, Republic of
Local Institution
Chisinau, Moldova, Republic of, MD 2025
Poland
Oddzial Kliniczny Hematologii i Profilaktyki Chorob Nowotworowych
Chorzow, Poland, 41-500
Specjalistyczny Gabinet Lekarski Prof. dr hab. Krzysztof Giannopoulos
Lublin, Poland, 20-601
Local Institution
Warszawa, Poland, 02-106
Russian Federation
Local Institution
Saint-Petersburg, Russian Federation, 194356
Local Institution
Smolensk, Russian Federation
United Kingdom
Local Institution
London, Greater London, United Kingdom, NW1 2PG
Local Institution
Manchester, Greater Manchester, United Kingdom, M13 9WL
Local Institution
Glasgow, Lanarkshire, United Kingdom, G4 OSF
Local Institution
London, United Kingdom, E1 1BB
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Study Protocol  [PDF] August 8, 2016
Statistical Analysis Plan  [PDF] January 14, 2015


Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02273960    
Other Study ID Numbers: IM140-103
2014-001429-33 ( EudraCT Number )
First Posted: October 24, 2014    Key Record Dates
Results First Posted: April 1, 2019
Last Update Posted: July 16, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases