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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-29

Study Completion Date

2022-07-09

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Acquired Hemophilia A

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Steroid

Intervention Type DRUG

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

Rituximab

Intervention Type DRUG

375mg/m2 for one dose

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)

Group Type ACTIVE_COMPARATOR

Steroid

Intervention Type DRUG

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

Cyclophosphamide

Intervention Type DRUG

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

Interventions

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Steroid

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

Intervention Type DRUG

Rituximab

375mg/m2 for one dose

Intervention Type DRUG

Cyclophosphamide

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

Intervention Type DRUG

Other Intervention Names

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Corticosteroid

Eligibility Criteria

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Inclusion Criteria

* 18-80 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/kg（or 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No