Trial of Acquired Haemophilia With Steroid Combined With Cyclophosphamide Versus Steroid Combined… (NCT03384277) | Clinical Trial Compass
CompletedPhase 4
Trial of Acquired Haemophilia With Steroid Combined With Cyclophosphamide Versus Steroid Combined With Rituximab
China66 participantsStarted 2017-12-29
Plain-language 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
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of inhibitor eradication and time to attain first remission
Timeframe: During 18 months
Trial details
NCT IDNCT03384277
SponsorInstitute of Hematology & Blood Diseases Hospital, China