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

Conditions

• Acquired Hemophilia A

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Steroid — DRUG
  Methylprednisolone 0.8 mg/kg/day (or equivalent corticosteroid doses) for 3 weeks（then tapering gradually, 8 weeks in total）
• Rituximab — DRUG
  375mg/m2 for one dose
• Cyclophosphamide — DRUG
  cyclophosphamide 2 mg/kg/day until inhibitor negative (no longer than five weeks)

Study Details

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

Key Dates

Start date

Dec 29, 2017

Status verified

Jun 2023

Primary completion

Jun 9, 2022

Completion

Jul 9, 2022

Study Design

Enrollment

66 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Steroid+Rituximab
  Methylprednisolone 0.8 mg/kg/day (or equivalent corticosteroid doses) for 3 weeks（then tapering gradually, 8 weeks in total）+Rituximab 375mg/m2 for one dose.
• Active Comparator: Steroid +Cyclophosphamide
  Methylprednisolone 0.8 mg/kg/day (or equivalent corticosteroid doses) for 3 weeks （ then tapering gradually, 8 weeks in total）+ Cyclophosphamide 2 mg/kg/day until inhibitor negative (no longer than five weeks)

Primary Outcome Measure

Proportion of inhibitor eradication and time to attain first remission [ Time Frame: During 18 months ]