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Trial of Acquired Haemophilia With Steroid Combined With Cyclophosphamide Versus Steroid Combined With Rituximab

NCT03384277 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-02-11

No results posted yet for this study

Summary

Purpose:

To evaluate the efficacy when administering steroid combined with single dose rituximab to eliminate the antibody in acquired hemophilia A patients compared to treatment using steroid with cyclophosphamide.

The study will test the hypothesis that steroid combined with small dose rituximab is as effective as steroid combined with cyclophosphamide for FVIII inhibitor eradication in Chinese patients with acquired hemophilia A.

Study design Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment

Conditions

  • Acquired Hemophilia A

Interventions

DRUG

Steroid

Methylprednisolone 0.8 mg/kg/day (or equivalent corticosteroid doses) for 3 weeks（then tapering gradually, 8 weeks in total）

DRUG

Rituximab

375mg/m2 for one dose

DRUG

Cyclophosphamide

cyclophosphamide 2 mg/kg/day until inhibitor negative (no longer than five weeks)

Sponsors & Collaborators

  • Qilu Hospital of Shandong University

    collaborator OTHER

  • Tianjin First Central Hospital

    collaborator OTHER

  • The Second Affiliated Hospital of Kunming Medical University

    collaborator OTHER

  • Henan Cancer Hospital

    collaborator OTHER_GOV

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Principal Investigators

  • Lei Zhang, MD · Blood disease hospital, Chinese academy of medical sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-29
Primary Completion
2022-06-09
Completion
2022-07-09

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT03384277 on ClinicalTrials.gov