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

• Register: ClinicalTrials.gov
• Last refreshed on: 26 June 2023
• Main ID: NCT03384277
• Date of registration: 28/11/2017
• Prospective Registration: Yes
• Primary sponsor: Zhang Lei, MD
• Public title: Trial of Acquired Haemophilia With Steroid Combined With Cyclophosphamide Versus Steroid Combined With Rituximab
• Scientific title: A Prospective, Randomized, Multicenter Clinical Trial of Acquired Haemophilia A With Steroid Combined With Cyclophosphamide Versus Steroid Combined With Rituximab
• Date of first enrolment: December 29, 2017
• Target sample size: 66
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03384277
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

China

Contacts

• Name: Lei Zhang, MD
• Affiliation: Blood disease hospital, Chinese academy of medical sciences

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Acquired Hemophilia A

Intervention(s)

Drug: Cyclophosphamide

Drug: Rituximab

Drug: Steroid

Primary Outcome(s)

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

Secondary Outcome(s)

Relapse rate and time to relapse [Time Frame: During 18 month]

Secondary ID(s)

IHBDH-IIT2017006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Qilu Hospital of Shandong University

The Second Affiliated Hospital of Kunming Medical University

Henan Cancer Hospital

Tianjin First Central Hospital