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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
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)
Secondary ID [1] 0 0
2014-001429-33
Secondary ID [2] 0 0
IM140-103
Universal Trial Number (UTN)
Trial acronym
ITP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Immune Thrombocytopenic Purpura 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Short Term and Long Term
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
Timepoint [1] 0 0
Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)
Primary outcome [2] 0 0
Number of ECG Abnormalities
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)
Timepoint [2] 0 0
Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)
Primary outcome [3] 0 0
Number of Laboratory Abnormalities of Safety Biomarkers: d-Dimer and Thrombin Anti-Thrombin (TAT)
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.
Timepoint [3] 0 0
Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long Term)
Secondary outcome [1] 0 0
Response Rate (RR) of BMS-986004: Short Term and Long Term
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.
Timepoint [1] 0 0
Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)
Secondary outcome [2] 0 0
Maximum Observed Serum Concentration (Cmax) of BMS-986004
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.
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)
Secondary outcome [3] 0 0
Area Under the Concentration-time Curve in One Dosing Interval [AUC(TAU)] of BMS-986004
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.
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)
Secondary outcome [4] 0 0
Trough Observed Serum Concentration (Ctrough) of BMS-986004
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.
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)
Secondary outcome [5] 0 0
Total Body Clearance (CLT) of BMS-986004
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.
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)
Secondary outcome [6] 0 0
AUC Accumulation Index (AI_AUC) of BMS-986004
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.
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)

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Secondary immune thrombocytopenia
* Drug induced thrombocytopenia

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/11/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/01/2018
Sample size
Target
Accrual to date
Final
46
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Local Institution - Randwick
Recruitment hospital [2] 0 0
Local Institution - Brisbane
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
4102 - Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Georgia
State/province [7] 0 0
Tbilisi
Country [8] 0 0
Moldova, Republic of
State/province [8] 0 0
Chisinau
Country [9] 0 0
Poland
State/province [9] 0 0
Chorzow
Country [10] 0 0
Poland
State/province [10] 0 0
Lublin
Country [11] 0 0
Poland
State/province [11] 0 0
Warszawa
Country [12] 0 0
Russian Federation
State/province [12] 0 0
Saint-Petersburg
Country [13] 0 0
Russian Federation
State/province [13] 0 0
Smolensk
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Greater London
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Greater Manchester
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Lanarkshire
Country [17] 0 0
United Kingdom
State/province [17] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02273960