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Emicizumab in Patients With Acquired Hemophilia A (AHAEmi)

Primary Purpose

Acquired Hemophilia A

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
emicizumab
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acquired Hemophilia A focused on measuring Acquire Hemophilia A, emicizumab, AHA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed Informed Consent/Assent Form
  • Age ≥18 years at time of signing Informed Consent Form
  • Ability to comply with the study protocol, in the investigator's judgment
  • Diagnosis of AHA based on a reduced FVIII activity (<50 %) and positive FVIII inhibitor (>0.6 BU/ml) at screening (local laboratory)
  • Current bleeding due to AHA at the time of screening
  • Plan to be adherent to emicizumab prophylaxis during the study
  • For women of childbearing potential who meet the following criteria:
  • Refrain from heterosexual intercourse or use contraceptive methods that result in a failure rate of <1% per year during the study period A woman with ≥ 12 continuous months of amenorrhea with no identified cause other than menopause and has not undergone surgical sterilization (removal of ovaries and/or uterus). use of combined oral or injected hormonal contraceptive, bilateral tubal ligation, male sterilization, hormone- releasing intrauterine devices, and copper intrauterine devices.

Exclusion Criteria:

  • Congenital hemophilia A
  • Treatment with aPCC within the last 24 hours before first study treatment or planned treatment with aPCC during the course of the study
  • Known positive lupus anticoagulant at the time of screening
  • Severe uncontrolled infection at the time of screening
  • Signs of active disseminated intravascular coagulation at the time of screening -
  • Emicizumab ⎯ AHA Emi Version 1.0 20
  • Current treatment for thromboembolic disease or signs of current thromboembolic disease at time of screening
  • Patients who are at high risk for TMA (e.g., have a previous medical or family history of TMA), in the investigator's judgment
  • Known severe congenital or acquired thrombophilia
  • Life expectancy <3 months at the time of screening
  • Other conditions that substantially increase risk of bleeding or thrombosis by the discretion of the investigator
  • Contraindications according to the Investigator's Brochure of emicizumab
  • Current treatment with emicizumab at time of screening
  • History of clinically significant hypersensitivity associated with monoclonal antibody therapies or components of the emicizumab injection by the discretion of the investigator
  • Concurrent disease, treatment, or abnormality in clinical laboratory tests that could interfere with the conduct of the study, may pose additional risk, or would, in the opinion of the local investigator, preclude the patient's safe participation in and completion of the study
  • Addiction or other diseases that preclude the patient from appropriately assessing the nature and scope as well as possible consequences of the clinical study by the discretion of the investigator
  • Pregnant or breast-feeding women
  • Would refuse treatment with blood or blood products, if necessary.
  • Subject is in custody by order of an authority or a court of law
  • Treatment with any of the following:
  • An investigational drug to treat or reduce the risk of hemophilic bleeds within 5 half-lives of last drug administration before Study Day 1
  • A non-hemophilia-related investigational drug within the last 30 days or 5 half-lives- before Study Day 1, whichever is longer
  • An investigational drug concurrently
  • History of clinically significant hypersensitivity associated with monoclonal antibody therapies or components of the emicizumab injection

Sites / Locations

  • Bleeding and Clotting Disorders InstituteRecruiting
  • Indiana Hemophilia and Thrombosis Center, Inc.Recruiting
  • Mayo ClinicRecruiting
  • Washington Center for Bleeding DisordersRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental-treatment

Arm Description

Treatment with emicizumab

Outcomes

Primary Outcome Measures

Primary Outcome Meassure
Number of clinically significant bleeds after 12 weeks of study drug (emicizumab)

Secondary Outcome Measures

Incidence and severity of adverse events
Incidence and severity of adverse events, including thromboembolic events, thrombotic microangiopathy in the 12 weeks after starting emicizumab treatment; mortality and cause of death in the 24 weeks after starting emicizumab treatment.
Days of treatment with additional hemostatic agent
Days of treatment with and total dose of bypassing agents (recombinant factor VIIa, activated prothrombin complex concentrate) or recombinant porcine factor VIII (susoctocag alfa) or other factor VIII concentrates; specifics (drug, amount and timing) of IST started during the 12 weeks of emicizumab prophylaxis
Remission Rate
Number of patients achieving partial remission (PR) and complete remission (CR) over 12 and 24 weeks after starting emicizumab prophylaxis
Hospitalizations
Days in hospital during week 12 of emicizumab treatment
Total dose of additional hemostatic agent
Total dose of bypassing agents (recombinant factor VIIa, activated prothrombin complex concentrate) or recombinant porcine factor VIII (susoctocag alfa) or other factor VIII concentrates; specifics (drug, amount and timing) of IST started during the 12 weeks of emicizumab prophylaxis

Full Information

First Posted
April 18, 2022
Last Updated
October 2, 2023
Sponsor
University of Washington
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05345197
Brief Title
Emicizumab in Patients With Acquired Hemophilia A
Acronym
AHAEmi
Official Title
Emicizumab in Patients With Acquired Hemophilia A: Multicenter, Single-arm, Open-label Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Genentech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a phase II multicenter open-label, single-arm prospective study to evaluate the efficacy of prophylactic emicizumab administered on a scheduled basis to prevent bleeds in patients with acquired hemophilia A (AHA).
Detailed Description
Patients with AHA who are eligible will receive two loading doses of the study drug, emicizumab (6mg/kg on day 1 and 3 mg/kg on day 2) followed by once weekly subcutaneous emicizumab (1.5 mg/kg). Immunosuppression will be given concurrently as per investigator discretion. The primary endpoint (bleed rate) will be assessed after 12 weeks on study drug. If partial remission of the AHA has not been achieved, an additional 12 weeks of study drug may be given. A historical cohort and a study conducted in parallel in Germany (NCT04188639) will serve as control groups for evaluation of secondary endpoints provided the study cohort are comparable.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Hemophilia A
Keywords
Acquire Hemophilia A, emicizumab, AHA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental-treatment
Arm Type
Experimental
Arm Description
Treatment with emicizumab
Intervention Type
Drug
Intervention Name(s)
emicizumab
Other Intervention Name(s)
Hemlibra (R)
Intervention Description
This study design uses emicizumab as a prophylaxis treatment to prevent bleeding for all participants, bypassing agents (with the exception of aPCC) and treatment of concomitant diseases will be given as clinically indicated. All eligible subjects with AHA will receive the same study medication consisting of: two loading doses of the emicizumab on day 1 and 2 followed by once weekly subcutaneous emicizumab injections. Immunosuppressive therapy (IST) will be given concurrently as per investigator discretion.
Primary Outcome Measure Information:
Title
Primary Outcome Meassure
Description
Number of clinically significant bleeds after 12 weeks of study drug (emicizumab)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Incidence and severity of adverse events
Description
Incidence and severity of adverse events, including thromboembolic events, thrombotic microangiopathy in the 12 weeks after starting emicizumab treatment; mortality and cause of death in the 24 weeks after starting emicizumab treatment.
Time Frame
duration of entire study
Title
Days of treatment with additional hemostatic agent
Description
Days of treatment with and total dose of bypassing agents (recombinant factor VIIa, activated prothrombin complex concentrate) or recombinant porcine factor VIII (susoctocag alfa) or other factor VIII concentrates; specifics (drug, amount and timing) of IST started during the 12 weeks of emicizumab prophylaxis
Time Frame
12 weeks
Title
Remission Rate
Description
Number of patients achieving partial remission (PR) and complete remission (CR) over 12 and 24 weeks after starting emicizumab prophylaxis
Time Frame
1 to 24 weeks
Title
Hospitalizations
Description
Days in hospital during week 12 of emicizumab treatment
Time Frame
12 weeks
Title
Total dose of additional hemostatic agent
Description
Total dose of bypassing agents (recombinant factor VIIa, activated prothrombin complex concentrate) or recombinant porcine factor VIII (susoctocag alfa) or other factor VIII concentrates; specifics (drug, amount and timing) of IST started during the 12 weeks of emicizumab prophylaxis
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Comparison of historic GTH-AH 01/2020 cohort/ Number of clinically significant bleeds
Description
Number of clinically significant bleeds in the 12 weeks of emicizumab treatment or until achieving partial remission (PR) of AHA, whatever occurs first Incidence and severity of adverse events, thromboembolic events, thrombotic microangiopathy, in 12 weeks of treatment and mortality after 24 weeks Bleeding-free survival until week 12 after starting treatment
Time Frame
12 to 24 weeks
Title
Comparison to a parallel German study cohort/ Number of clinically significant bleeds
Description
Number of clinically significant bleeds per patient-week until death or week 12 after starting emicizumab treatment, whatever occurs first Incidence and severity of adverse events, thromboembolic events, in the 12 weeks of emicizumab treatment and mortality after 24 weeks Bleeding-free survival until week 12 of emicizumab treatment
Time Frame
12 to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed Informed Consent/Assent Form Age ≥18 years at time of signing Informed Consent Form Ability to comply with the study protocol, in the investigator's judgment Diagnosis of AHA based on a reduced FVIII activity (<50 %) and positive FVIII inhibitor (>0.6 BU/ml) at screening (local laboratory) Current bleeding due to AHA at the time of screening Plan to be adherent to emicizumab prophylaxis during the study For women of childbearing potential who meet the following criteria: Refrain from heterosexual intercourse or use contraceptive methods that result in a failure rate of <1% per year during the study period A woman with ≥ 12 continuous months of amenorrhea with no identified cause other than menopause and has not undergone surgical sterilization (removal of ovaries and/or uterus). use of combined oral or injected hormonal contraceptive, bilateral tubal ligation, male sterilization, hormone- releasing intrauterine devices, and copper intrauterine devices. Exclusion Criteria: Congenital hemophilia A Treatment with aPCC within the last 24 hours before first study treatment or planned treatment with aPCC during the course of the study Known positive lupus anticoagulant at the time of screening Severe uncontrolled infection at the time of screening Signs of active disseminated intravascular coagulation at the time of screening - Emicizumab ⎯ AHA Emi Version 1.0 20 Current treatment for thromboembolic disease or signs of current thromboembolic disease at time of screening Patients who are at high risk for TMA (e.g., have a previous medical or family history of TMA), in the investigator's judgment Known severe congenital or acquired thrombophilia Life expectancy <3 months at the time of screening Other conditions that substantially increase risk of bleeding or thrombosis by the discretion of the investigator Contraindications according to the Investigator's Brochure of emicizumab Current treatment with emicizumab at time of screening History of clinically significant hypersensitivity associated with monoclonal antibody therapies or components of the emicizumab injection by the discretion of the investigator Concurrent disease, treatment, or abnormality in clinical laboratory tests that could interfere with the conduct of the study, may pose additional risk, or would, in the opinion of the local investigator, preclude the patient's safe participation in and completion of the study Addiction or other diseases that preclude the patient from appropriately assessing the nature and scope as well as possible consequences of the clinical study by the discretion of the investigator Pregnant or breast-feeding women Would refuse treatment with blood or blood products, if necessary. Subject is in custody by order of an authority or a court of law Treatment with any of the following: An investigational drug to treat or reduce the risk of hemophilic bleeds within 5 half-lives of last drug administration before Study Day 1 A non-hemophilia-related investigational drug within the last 30 days or 5 half-lives- before Study Day 1, whichever is longer An investigational drug concurrently History of clinically significant hypersensitivity associated with monoclonal antibody therapies or components of the emicizumab injection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danielle Matia, MPH
Phone
206-614-1157
Ext
1017
Email
danielle.matia@wacbd.org
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Ruuska, MPH
Phone
2066497415
Ext
1017
Email
sarah.ruuska@wacbd.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Kruse-Jarres, MD, MPH
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bleeding and Clotting Disorders Institute
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shayla Nunn
Phone
309-692-5337
Ext
135
Email
shayla@ilbcdi.org
First Name & Middle Initial & Last Name & Degree
Nikki Barclay
Phone
309-692-5337
Ext
139
Email
nikki@ilbcdi.org
First Name & Middle Initial & Last Name & Degree
Jonathan C. Roberts, MD
Facility Name
Indiana Hemophilia and Thrombosis Center, Inc.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Okungade, MB, BS
Phone
317-871-0000
Ext
1118
Email
jokungade@ihtc.org
First Name & Middle Initial & Last Name & Degree
Neelam Thukral
Phone
317 871-0000
Ext
1373
Email
nthukral@ihtc.org
First Name & Middle Initial & Last Name & Degree
Brandon M. Hardesty, MD
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Chadbourn
Phone
507-422-3810
Email
Chadbourn.emma@mayo.edu
First Name & Middle Initial & Last Name & Degree
Rebecca Trogstad
Phone
507 284 5095
Email
Trogstad.Rebecca@mayo.edu
First Name & Middle Initial & Last Name & Degree
Meera Sridharan, M.d., PhD.
First Name & Middle Initial & Last Name & Degree
Rajiv Pruthi, M.B.B.S.
Facility Name
Washington Center for Bleeding Disorders
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle M. Matia, MPH
Phone
206-614-1157
Ext
1016
Email
danielle.matia@wacbd.org
First Name & Middle Initial & Last Name & Degree
Sarah Ruuska, MPH
Phone
12066497415
Ext
1017
Email
sarah.ruuska@wacbd.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All of the individual participant data collected during the trial will be shared with the research group of the parallel European study (NCT04188639). Data will be shared at the end of the study for analysis for a period of 2 years.
IPD Sharing Time Frame
Data will be shared with the research group of the parallel European study (NCT04188639) at the end of the study and will be available for 2 years.
IPD Sharing Access Criteria
Only researchers of this or the parallel trial (NCT04188639) will have access to this data.
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Emicizumab in Patients With Acquired Hemophilia A

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