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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06568302




Registration number
NCT06568302
Ethics application status
Date submitted
21/08/2024
Date registered
23/08/2024
Date last updated
1/11/2024

Titles & IDs
Public title
The Long-term Safety and Efficacy of SerpinPC in Subjects with Hemophilia Who Completed a Sponsored SerpinPC Clinical Trial
Scientific title
A Global Open-label Extension Study to Observe the Long-term Safety and Efficacy of SerpinPC in Subjects with Hemophilia Who Completed a Sponsored SerpinPC Clinical Trial
Secondary ID [1] 0 0
2023-509965-19
Secondary ID [2] 0 0
AP-0106
Universal Trial Number (UTN)
Trial acronym
PRESent-6
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hemophilia a 0 0
Hemophilia B 0 0
Hemophilia a with Inhibitor 0 0
Hemophilia B with Inhibitor 0 0
Condition category
Condition code
Blood 0 0 0 0
Clotting disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SerpinPC

Experimental: SerpinPC - Participants will receive SerpinPC 1.2 milligrams/kilograms (mg/kg) subcutaneous injection every 2 weeks (Q2W) once they have completed treatment in a SerpinPC parent study.


Treatment: Drugs: SerpinPC
Administered as SC injection.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treated bleeds, expressed as annualized bleeding rate (ABR)
Timepoint [1] 0 0
Month 0 to Month 25 or Early termination
Secondary outcome [1] 0 0
Treated spontaneous bleeds (expressed as ABR)
Timepoint [1] 0 0
Month 0 to Month 25 or Early termination
Secondary outcome [2] 0 0
Treated spontaneous joint bleeds (expressed as ABR)
Timepoint [2] 0 0
Month 0 to Month 25 or Early termination
Secondary outcome [3] 0 0
All bleeds requiring treatment (expressed as ABR, ie, all treated bleeds and all bleeds that would ordinarily be treated with factor concentrate/bypass agent if therapy were available)
Timepoint [3] 0 0
Month 0 to Month 25 or Early termination
Secondary outcome [4] 0 0
Total coagulation factor and/or bypass product consumption
Timepoint [4] 0 0
Month 0 to Month 25 or Early termination

Eligibility
Key inclusion criteria
* Male participants greater than or equal to (>=) 12 and less than or equal to (<=) 65 years of age at the time of informed consent
* Completed participation in a sponsored SerpinPC hemophilia clinical trial and, in the opinion of the investigator, was compliant with the study including compliance with diary entries.
* Capable of providing written informed consent (adolescent assent and parent/guardian consent when appropriate) for participation
Minimum age
12 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous deep vein thrombosis and pulmonary embolism, myocardial infarction, or embolic stroke
* Participation in another interventional clinical trial, except for SerpinPC trials
* Any other significant conditions or comorbidities that, in the opinion of the investigator, would make the subject unsuitable for enrolment or could interfere with participation in or completion of the study
* Treatment with anticoagulant or antiplatelet drugs

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Other
Other design features
Phase
Phase 3
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
11/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2028
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
NSW 2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Iowa
Country [3] 0 0
United States of America
State/province [3] 0 0
Pennsylvania
Country [4] 0 0
Armenia
State/province [4] 0 0
Yerevan
Country [5] 0 0
Belgium
State/province [5] 0 0
Bruxelles
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
France
State/province [7] 0 0
Lille
Country [8] 0 0
France
State/province [8] 0 0
Paris
Country [9] 0 0
Georgia
State/province [9] 0 0
Tbilisi
Country [10] 0 0
Germany
State/province [10] 0 0
Sachsen
Country [11] 0 0
Germany
State/province [11] 0 0
Berlin
Country [12] 0 0
India
State/province [12] 0 0
Maharashtra
Country [13] 0 0
India
State/province [13] 0 0
Mumbai
Country [14] 0 0
India
State/province [14] 0 0
Punjab
Country [15] 0 0
Italy
State/province [15] 0 0
Milan
Country [16] 0 0
Italy
State/province [16] 0 0
Udine
Country [17] 0 0
Moldova, Republic of
State/province [17] 0 0
Chisinau
Country [18] 0 0
Poland
State/province [18] 0 0
Podkarpackie
Country [19] 0 0
South Africa
State/province [19] 0 0
Eastern Cape
Country [20] 0 0
Spain
State/province [20] 0 0
Madrid
Country [21] 0 0
Spain
State/province [21] 0 0
Murcia
Country [22] 0 0
Spain
State/province [22] 0 0
Málaga
Country [23] 0 0
Taiwan
State/province [23] 0 0
Taichung
Country [24] 0 0
Taiwan
State/province [24] 0 0
Taipei City
Country [25] 0 0
Taiwan
State/province [25] 0 0
Taipei
Country [26] 0 0
Turkey
State/province [26] 0 0
Izmir
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Kent
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Oxfordshire
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Scotland
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Cardiff
Country [31] 0 0
United Kingdom
State/province [31] 0 0
London
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Newcastle Upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ApcinteX Ltd
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Centessa Pharmaceuticals plc
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study is to evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) profile of prophylactic SerpinPC in participants with hemophilia
Trial website
https://clinicaltrials.gov/study/NCT06568302
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Centessa Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
617-468-5770
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06568302