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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05070845




Registration number
NCT05070845
Ethics application status
Date submitted
27/09/2021
Date registered
7/10/2021

Titles & IDs
Public title
Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia
Scientific title
AN INTERVENTIONAL PHASE 2, OPEN-LABEL, MULTI-CENTER STUDY TO EVALUATE SAFETY AND EFFICACY OF PF-06835375 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE PRIMARY IMMUNE THROMBOCYTOPENIA
Secondary ID [1] 0 0
2021-002897-19
Secondary ID [2] 0 0
C1131003
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - PF-06835375

Experimental: Open Label PF-06835375 dose 1 Treatment - subcutaneous injection once monthly for 3 months

Experimental: Open Label PF-06835375 dose 2 Treatment - subcutaneous injection once monthly for 4 months


Treatment: Other: PF-06835375
CXCR5 inhibitor
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants with change from baseline of platelet counts
Timepoint [1] 0 0
baseline through 12 and 16 weeks
Secondary outcome [1] 0 0
proportion of participants with modified overall response (mOR)
Timepoint [1] 0 0
baseline through 12 and 16 weeks
Secondary outcome [2] 0 0
proportion of participants with complete response (CR)
Timepoint [2] 0 0
baseline through 12 and 16 weeks
Secondary outcome [3] 0 0
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Timepoint [3] 0 0
baseline through end of study (Week 20 for cohort 1 and Week 24 for cohort 2)
Secondary outcome [4] 0 0
Proportion of participants with change from baseline of platelet counts
Timepoint [4] 0 0
baseline to Week 20 and Week 24
Secondary outcome [5] 0 0
Proportion of participants with change from baseline of circulating B cells
Timepoint [5] 0 0
baseline to Week 20 and Week 24
Secondary outcome [6] 0 0
Proportion of participants with change from baseline of circulating cTfh cells
Timepoint [6] 0 0
baseline to Week 20 and Week 24

Eligibility
Key inclusion criteria
* Diagnosis of Primary ITP. Ongoing ITP (platelet counts <50 x 109/L) [No severe bleeding within 1 month or during screening] AND Persistent ITP (3 to 12 months) or Chronic ITP >12 months
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Bleeding event according to the WHO grading scale =2 occurring =4 weeks prior to screen OR a current bleeding event that, in the opinion of the investigator, requires treatment with standard of care therapy OR require blood or blood products during screening
* Splenectomy within 3 months of randomization or planned during the study duration.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/10/2026
Actual
Sample size
Target
61
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Clinical Research Unit Haematology, Division of Cancer Services, St. George Hospital - Kogarah
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
South West Radiology - Liverpool
Recruitment hospital [4] 0 0
Slade Pharmacy - Mount Kuring-Gai
Recruitment hospital [5] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [6] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [7] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [8] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2080 - Mount Kuring-Gai
Recruitment postcode(s) [4] 0 0
2298 - Waratah
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment postcode(s) [7] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Canada
State/province [7] 0 0
Quebec
Country [8] 0 0
Czechia
State/province [8] 0 0
Hradec Kralove
Country [9] 0 0
Czechia
State/province [9] 0 0
Praha 2
Country [10] 0 0
Hungary
State/province [10] 0 0
Baranya
Country [11] 0 0
Hungary
State/province [11] 0 0
Somogy
Country [12] 0 0
Hungary
State/province [12] 0 0
Budapest
Country [13] 0 0
Hungary
State/province [13] 0 0
Györ
Country [14] 0 0
Poland
State/province [14] 0 0
Wielkopolskie
Country [15] 0 0
Poland
State/province [15] 0 0
Bialystok
Country [16] 0 0
Poland
State/province [16] 0 0
Gdansk
Country [17] 0 0
Poland
State/province [17] 0 0
Katowice
Country [18] 0 0
Poland
State/province [18] 0 0
Poznan
Country [19] 0 0
Poland
State/province [19] 0 0
Wroclaw
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Devon

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Country 0 0
Phone 0 0
1-800-718-1021
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05070845