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ITI Using SCT800 Alone or Combining Daratumumab in Hemophilia A Adolescents and Adults With High Titer Inhibitor

Primary Purpose

Hemophilia A With Inhibitor

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
SCT800 and Daratumumab
SCT800
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 Hemophilia A With Inhibitor

Eligibility Criteria

14 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Moderate or severe hemophilia A; Aged 14-66 years old; Inhibitor positive at 2 consecutive visits; Inhibitor titer > 10 BU at the screening visit. Exclusion Criteria: The patient has contraindications to drug ingredients or hamster protein allergy; Suffering from other immune diseases or Using immunosuppressant IS to treat another disease(s); Failed systemic ITI treatment in history; Poor patients compliance; The investigator believes that there are any other reasons that make the patient unsuitable to participate in this study.

Sites / Locations

  • Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SCT800 combined with Daratumumab

SCT800 alone

Arm Description

ITI using low-dose domestic rFVIII (SCT800) (50IU/kg TIW) and treated with Daratumumab 8mg/kg 4-8 times. Other immunosuppressants could be added after 3 months.

ITI using low-dose domestic rFVIII (SCT800) (50IU/kg TIW) alone. Other immunosuppressants could be added after 3 months.

Outcomes

Primary Outcome Measures

success rate of ITI success rate of ITI success rate of ITI success rate of ITI
Inhibitor titre <0.6 BU⁄mL
Success rate and partial success rate of ITI after 3-month treatment
Inhibitor titre <0.6 BU⁄mL

Secondary Outcome Measures

ITI success time
time to successful tolerance

Full Information

First Posted
May 24, 2023
Last Updated
June 18, 2023
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Collaborators
Sinocelltech Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05888870
Brief Title
ITI Using SCT800 Alone or Combining Daratumumab in Hemophilia A Adolescents and Adults With High Titer Inhibitor
Official Title
The Outcome Comparison of Immune Tolerance Induction Therapy Using SCT800 Combined With Daratumumab or SCT800 Alone in Hemophilia A Adolescents and Adults With High Titer Inhibitor: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2026 (Anticipated)
Study Completion Date
December 1, 2026 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
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 with SCT800 (rFVIII) in the treatment of hemophilia A adolescents and adults with high titer inhibitors.
Detailed Description
This is a randomized controlled trial to compare the outcome of immune tolerance induction therapy using SCT800 combined with Daratumumab or SCT800 alone in hemophilia A adolescents and adults with high titer inhibitors. Patients will receive Daratumumab combined with SCT800 or SCT800 alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia A With Inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SCT800 combined with Daratumumab
Arm Type
Experimental
Arm Description
ITI using low-dose domestic rFVIII (SCT800) (50IU/kg TIW) and treated with Daratumumab 8mg/kg 4-8 times. Other immunosuppressants could be added after 3 months.
Arm Title
SCT800 alone
Arm Type
Active Comparator
Arm Description
ITI using low-dose domestic rFVIII (SCT800) (50IU/kg TIW) alone. Other immunosuppressants could be added after 3 months.
Intervention Type
Drug
Intervention Name(s)
SCT800 and Daratumumab
Other Intervention Name(s)
Immune tolerance induction combine anti-CD38
Intervention Description
SCT800 50IU/kg TIW alone or treated with Daratumumab 8mg/kg 4-8 times
Intervention Type
Drug
Intervention Name(s)
SCT800
Other Intervention Name(s)
Immune tolerance induction only
Intervention Description
SCT800 50IU/kg TIW alone
Primary Outcome Measure Information:
Title
success rate of ITI success rate of ITI success rate of ITI success rate of ITI
Description
Inhibitor titre <0.6 BU⁄mL
Time Frame
12 months
Title
Success rate and partial success rate of ITI after 3-month treatment
Description
Inhibitor titre <0.6 BU⁄mL
Time Frame
3 months
Secondary Outcome Measure Information:
Title
ITI success time
Description
time to successful tolerance
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Moderate or severe hemophilia A; Aged 14-66 years old; Inhibitor positive at 2 consecutive visits; Inhibitor titer > 10 BU at the screening visit. Exclusion Criteria: The patient has contraindications to drug ingredients or hamster protein allergy; Suffering from other immune diseases or Using immunosuppressant IS to treat another disease(s); Failed systemic ITI treatment in history; Poor patients compliance; The investigator believes that there are any other reasons that make the patient unsuitable to participate in this study.
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
First Name & Middle Initial & Last Name & Degree
Renchi Yang
Organizational Affiliation
Chinese Academy of Medical Science and Blood Disease Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
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
L Liu
Email
gcp@ihcams.ac.cn
First Name & Middle Initial & Last Name & Degree
Lei Zhang

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

ITI Using SCT800 Alone or Combining Daratumumab in Hemophilia A Adolescents and Adults With High Titer Inhibitor

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