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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2021
  • participants needed
    100
  • sponsor
    Zhang Lei
Updated on 23 January 2021

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

Description

This is a prospective randomized multi-center controlled pilot trial comparing the regimen of steroid with rituximab and steroid with cyclophosphamide to eradicate anti-factor VIII antibodies in Chinese patients with acquired hemophilia A.

Patients will be randomized to two regimens: methylprednisolone 0.8mg/kg/day (or equivalent corticosteroid doses) for 3 weeks (then tapering gradually,8 weeks in total) with rituximab (375mg/m2 for one dose) or methylprednisolone 0.8mg/kg/day (or equivalent corticosteroid doses) for 3 weeks (then tapering gradually,8 weeks in total) with cyclophosphamide 2mg/kg/day until inhibitor negative(no longer than five weeks).

Patients will be randomized to the treatment cohorts according to the biostatistical methods.

Details
Condition Acquired Hemophilia A
Treatment Rituximab, cyclophosphamide, Steroid, Steroid
Clinical Study IdentifierNCT03384277
SponsorZhang Lei
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 80 yrs?
Gender: Male or Female
Do you have Acquired Hemophilia A?
Do you have any of these conditions: Do you have Acquired Hemophilia A??
-80 years old
Men or women
Women post-menopausal or with ongoing contraception
Diagnosis of acquired hemophilia A
Patient must be insured
Patient has provided written informed consent prior to enrollment
Patient compliant

Exclusion Criteria

Congenital hemophilia
Ongoing treatment with prednisone > 20mg/d or equivalent corticosteroid doses more than 1 month
Ongoing treatment with prednisone >0.7mg/kgor equivalent corticosteroid doses more than 10 days
Pregnant and breastfeeding women
Allergy to steroid
Immunosuppressive agents treatment within 30 days
Serum transaminase and bilirubin greater than 1.5 times the upper limit of normal value
Hepatitis B surface antigen or hepatitis C antibody or HIV antibody (I + II) or syphilis antibody positive
Patients with diabetes, hypertension, glaucoma, peptic ulcer, herpes zoster, pulmonary infection and so on, who should not be treated with glucocorticoids
Patients with poor compliance
Those who can not take contraceptive measures during the test period
Patient who is considered by the investigator not suitable for clinical study
Thrombocytopenia
Leucocytopenia
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