Status:
COMPLETED
Trial of Acquired Haemophilia With Steroid Combined With Cyclophosphamide Versus Steroid Combined With Rituximab
Lead Sponsor:
Zhang Lei, MD
Collaborating Sponsors:
Qilu Hospital of Shandong University
Tianjin First Central Hospital
Conditions:
Acquired Hemophilia A
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 c...
Detailed 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 Chine...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 9 2022
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT03384277
Start Date
December 29 2017
End Date
July 9 2022
Last Update
June 15 2023
Active Locations (1)
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1
Ethics Committee of Blood disease hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300020