Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02273960
Registration number
NCT02273960
Ethics application status
Date submitted
3/10/2014
Date registered
24/10/2014
Date last updated
16/07/2019
Titles & IDs
Public title
Study to Evaluate Safety and Efficacy in Adult Subjects With ITP
Query!
Scientific 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)
Query!
Secondary ID [1]
0
0
2014-001429-33
Query!
Secondary ID [2]
0
0
IM140-103
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
ITP
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Immune Thrombocytopenic Purpura
0
0
Query!
Condition category
Condition code
Inflammatory and Immune System
0
0
0
0
Query!
Autoimmune diseases
Query!
Blood
0
0
0
0
Query!
Other blood disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - BMS-986004 75 mg IV
Treatment: Drugs - BMS-986004 225 mg IV
Treatment: Drugs - BMS-986004 675 mg IV
Treatment: Drugs - BMS-986004 1500 mg IV
Experimental: Arm A: BMS-986004 - BMS-986004 solution intravenously (IV) as specified
Experimental: Arm B: BMS-986004 - BMS-986004 solution intravenously as specified
Experimental: Arm C: BMS-986004 - BMS-986004 solution intravenously as specified
Experimental: Arm D: BMS-986004 - BMS-986004 solution intravenously as specified
Treatment: Drugs: BMS-986004 75 mg IV
BMS-986004 (75 mg) infusion (50 ml) administered in 120 minutes
Treatment: Drugs: BMS-986004 225 mg IV
BMS-986004 (225 mg) infusion (100 ml) administered in 120 minutes
Treatment: Drugs: BMS-986004 675 mg IV
BMS-986004 (675 mg) infusion (100 ml) administered in 120 minutes
Treatment: Drugs: BMS-986004 1500 mg IV
BMS-986004 (1500 mg) infusion (100 ml) administered in 120 minutes
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Short Term and Long Term
Query!
Assessment method [1]
0
0
The primary objective to establish safety was measured by the primary endpoints of AEs and SAEs for both Short term and Long term periods
Query!
Timepoint [1]
0
0
Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)
Query!
Primary outcome [2]
0
0
Number of ECG Abnormalities
Query!
Assessment method [2]
0
0
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)
Query!
Timepoint [2]
0
0
Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)
Query!
Primary outcome [3]
0
0
Number of Laboratory Abnormalities of Safety Biomarkers: d-Dimer and Thrombin Anti-Thrombin (TAT)
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long Term)
Query!
Secondary outcome [1]
0
0
Response Rate (RR) of BMS-986004: Short Term and Long Term
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)
Query!
Secondary outcome [2]
0
0
Maximum Observed Serum Concentration (Cmax) of BMS-986004
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
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)
Query!
Secondary outcome [3]
0
0
Area Under the Concentration-time Curve in One Dosing Interval [AUC(TAU)] of BMS-986004
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
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)
Query!
Secondary outcome [4]
0
0
Trough Observed Serum Concentration (Ctrough) of BMS-986004
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
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)
Query!
Secondary outcome [5]
0
0
Total Body Clearance (CLT) of BMS-986004
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
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)
Query!
Secondary outcome [6]
0
0
AUC Accumulation Index (AI_AUC) of BMS-986004
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
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)
Query!
Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
* =18 years old, diagnosed with persistent or chronic ITP
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Secondary immune thrombocytopenia
* Drug induced thrombocytopenia
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
17/11/2014
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
22/01/2018
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
46
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Query!
Recruitment hospital [1]
0
0
Local Institution - Randwick
Query!
Recruitment hospital [2]
0
0
Local Institution - Brisbane
Query!
Recruitment postcode(s) [1]
0
0
2031 - Randwick
Query!
Recruitment postcode(s) [2]
0
0
4102 - Brisbane
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
District of Columbia
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Georgia
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Massachusetts
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
New Jersey
Query!
Country [6]
0
0
Canada
Query!
State/province [6]
0
0
Ontario
Query!
Country [7]
0
0
Georgia
Query!
State/province [7]
0
0
Tbilisi
Query!
Country [8]
0
0
Moldova, Republic of
Query!
State/province [8]
0
0
Chisinau
Query!
Country [9]
0
0
Poland
Query!
State/province [9]
0
0
Chorzow
Query!
Country [10]
0
0
Poland
Query!
State/province [10]
0
0
Lublin
Query!
Country [11]
0
0
Poland
Query!
State/province [11]
0
0
Warszawa
Query!
Country [12]
0
0
Russian Federation
Query!
State/province [12]
0
0
Saint-Petersburg
Query!
Country [13]
0
0
Russian Federation
Query!
State/province [13]
0
0
Smolensk
Query!
Country [14]
0
0
United Kingdom
Query!
State/province [14]
0
0
Greater London
Query!
Country [15]
0
0
United Kingdom
Query!
State/province [15]
0
0
Greater Manchester
Query!
Country [16]
0
0
United Kingdom
Query!
State/province [16]
0
0
Lanarkshire
Query!
Country [17]
0
0
United Kingdom
Query!
State/province [17]
0
0
London
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Bristol-Myers Squibb
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to assess the safety and tolerability of BMS-986004 when administered in subjects with ITP.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02273960
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bristol-Myers Squibb
Query!
Address
0
0
Bristol-Myers Squibb
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/60/NCT02273960/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/60/NCT02273960/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02273960
Download to PDF