New hope for rare bleeding disorder: Single-Dose rituximab may replace daily chemo
NCT ID NCT03384277
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested two treatments for acquired hemophilia A, a rare condition where the immune system attacks clotting factor VIII. 66 adults received either steroid plus a single dose of rituximab or steroid plus daily cyclophosphamide. The goal was to see which combination clears the harmful antibody faster and keeps it away longer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- steroid (methylprednisolone) combined with either rituximab or cyclophosphamide
- What this could lead to
- If successful, this could show that a single dose of rituximab works as well as daily cyclophosphamide for clearing the harmful antibody, offering a simpler treatment option.
- What could go wrong
- This is a small, completed Phase 4 trial with only 66 participants, so results may not apply to all patients. Both treatments have risks like infection and side effects from steroids.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
66 people
The number who actually took part.
- Started
-
Dec 2017
- Finished
-
Jul 2022
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Ethics Committee of Blood disease hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.