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An Exploratory Study of Cluster of Differentiation 38 (CD38) Monoclonal Antibody Combined Corticosteroid in Acquired Hemophilia A (AHA2023)

Primary Purpose

Acquired Hemophilia

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Daratumumab and corticosteroid treatment
Sponsored by
Institute of Hematology & Blood Diseases Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acquired Hemophilia

Eligibility Criteria

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

Inclusion Criteria: Patients must meet all enrollment criteria before they can be enrolled: Diagnosed as AHA; Women are postmenopausal women or women of childbearing age with strict contraception; Patients with good compliance Exclusion Criteria: Patients with any of the following items cannot be enrolled in this study: Congenital hemophilia with inhibitor; Pregnant and lactating women; Who are positive for hepatitis B surface antigen, hepatitis C antibody, HIV antibody (Ⅰ + Ⅱ) and syphilis antibody; Patients with poor compliance; Who cannot use contraception during the trial; Researchers believe that it is not appropriate for patients to participate in any other condition of this trial; Four weeks before entering the group, the patients received immunosuppressive therapy and the inhibitor showed a progressive decreasing trend (the change was less than 50%). Acquired von Willebrand disease

Sites / Locations

  • Chinese Academy of Medical Science and Blood Disease HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment arm

Arm Description

Daratumumab and corticosteroid treatment

Outcomes

Primary Outcome Measures

Total response rate to treatment (OR) Total response rate to treatment
The proportion of patients achieving OR including CR and PR

Secondary Outcome Measures

the proportion of patients with complete remission (CR)
The proportion of patients achieving CR , which is defined as titer FVIII inhibitor lower than 0.6 Bethesda unit, factor VIII level≥ 50%
the proportion of patients with partial remission rate (PR)
The proportion of patients achieving PR, which is defined as titer FVIII inhibitor higher than 0.6 Bethesda unit and factor VIII level≥ 50%, and no bleedings will be evaluated.
time to CR
The time for patients to reach complete remission
The proportion of patients remaining in CR during 24 weeks
The proportion of patients who reached CR and remain in CR during 24 weeks of follow -up time
The proportion of patients relapse after reaching CR during 24 weeks
The proportion of patients who reached CR and relapse during 24 weeks of follow -up time
Safety outcome
Adverse events will be collected

Full Information

First Posted
April 18, 2023
Last Updated
May 22, 2023
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT05849740
Brief Title
An Exploratory Study of Cluster of Differentiation 38 (CD38) Monoclonal Antibody Combined Corticosteroid in Acquired Hemophilia A
Acronym
AHA2023
Official Title
A Multicenter, Single-arm Exploratory Study of CD38 (Daratumumab) Monoclonal Antibody (Daratumumab) Combined Corticosteroid in the Treatment of Acquired Hemophilia A (AHA)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 22, 2023 (Actual)
Primary Completion Date
April 30, 2027 (Anticipated)
Study Completion Date
October 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Hematology & Blood Diseases Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the time of response, sustained remission rate and relapse rate of CD38 monoclonal antibody (Daratumumab) combined corticosteroid in the treatment of AHA. To evaluate the safety of CD38 monoclonal antibody in the treatment of AHA.
Detailed Description
This is a prospective ,single-arm, multi-center controlled pilot trial of CD38 (Daratumumab) monoclonal antibody combined corticosteroid in the treatment of AHA patients. Patients will receive Daratumumab and corticosteroid treatment in this trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Hemophilia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment arm
Arm Type
Experimental
Arm Description
Daratumumab and corticosteroid treatment
Intervention Type
Drug
Intervention Name(s)
Daratumumab and corticosteroid treatment
Other Intervention Name(s)
Intervention arm
Intervention Description
Daratumumab and corticosteroid treatment
Primary Outcome Measure Information:
Title
Total response rate to treatment (OR) Total response rate to treatment
Description
The proportion of patients achieving OR including CR and PR
Time Frame
During 8 weeks
Secondary Outcome Measure Information:
Title
the proportion of patients with complete remission (CR)
Description
The proportion of patients achieving CR , which is defined as titer FVIII inhibitor lower than 0.6 Bethesda unit, factor VIII level≥ 50%
Time Frame
During 8 weeks
Title
the proportion of patients with partial remission rate (PR)
Description
The proportion of patients achieving PR, which is defined as titer FVIII inhibitor higher than 0.6 Bethesda unit and factor VIII level≥ 50%, and no bleedings will be evaluated.
Time Frame
During 8 weeks
Title
time to CR
Description
The time for patients to reach complete remission
Time Frame
During 8 weeks
Title
The proportion of patients remaining in CR during 24 weeks
Description
The proportion of patients who reached CR and remain in CR during 24 weeks of follow -up time
Time Frame
During 24 weeks
Title
The proportion of patients relapse after reaching CR during 24 weeks
Description
The proportion of patients who reached CR and relapse during 24 weeks of follow -up time
Time Frame
During 24 weeks
Title
Safety outcome
Description
Adverse events will be collected
Time Frame
From start of the treatment until the end of 24 weeks in the follow-up period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must meet all enrollment criteria before they can be enrolled: Diagnosed as AHA; Women are postmenopausal women or women of childbearing age with strict contraception; Patients with good compliance Exclusion Criteria: Patients with any of the following items cannot be enrolled in this study: Congenital hemophilia with inhibitor; Pregnant and lactating women; Who are positive for hepatitis B surface antigen, hepatitis C antibody, HIV antibody (Ⅰ + Ⅱ) and syphilis antibody; Patients with poor compliance; Who cannot use contraception during the trial; Researchers believe that it is not appropriate for patients to participate in any other condition of this trial; Four weeks before entering the group, the patients received immunosuppressive therapy and the inhibitor showed a progressive decreasing trend (the change was less than 50%). Acquired von Willebrand disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Liu
Phone
+8613820261971
Email
liuwei1@ihcams.ac.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Zhang
Email
zhanglei1@ihcams.ac.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lei Zhang
Organizational Affiliation
Chinese Academy of Medical Science and Blood Disease Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese Academy of Medical Science and Blood Disease Hospital
City
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuo Chen
Email
chenshuo@ihcams.ac.cn
First Name & Middle Initial & Last Name & Degree
Lijun Liu
Email
gcp@ihcams.ac.cn

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data can be requested from the corresponding authors from 12 months to 36 months after study completion
IPD Sharing Time Frame
from 12 months to 36 months after study completion
IPD Sharing Access Criteria
From corresponding author

Learn more about this trial

An Exploratory Study of Cluster of Differentiation 38 (CD38) Monoclonal Antibody Combined Corticosteroid in Acquired Hemophilia A

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