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Emicizumab in Acquired Hemophilia A

NCT04188639 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2023-01-09

No results posted yet for this study

Summary

This study is an international, multicenter, open-label, single arm, prospective clinical trial and will evaluate the efficacy of prophylactic emicizumab administered on a scheduled basis to prevent bleeds in patients with acquired hemophilia A (AHA).

Conditions

  • Hemophilia A, Acquired

Interventions

DRUG

Emicizumab Injection

All eligible patients with AHA will receive the same study medication consisting of once weekly subcutaneous emicizumab. For each subject, the maximal duration of the study will be 24 weeks including 12 weeks treatment with emicizumab and 12 weeks follow-up with Immunosuppressive therapy (IST) at the investigators discretion.

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Hannover Medical School

    collaborator OTHER

  • GWT-TUD GmbH

    lead OTHER

Principal Investigators

  • Andreas Tiede, Prof. Dr. · Hannover Medical School

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-23
Primary Completion
2023-01-04
Completion
2023-01-04

Countries

  • Austria
  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04188639 on ClinicalTrials.gov