Clinical trial: Rituximab to Treat Severe Hemophilia A (NCT00331006)

Eligibility criteria:
Inclusion Criteria:

          -  Severe congenital hemophilia A

          -  Documented historical inhibitor titer to factor VIII of at least 5 BU/mL

          -  Inhibitor level greater than or equal to 5 BU/mL 5 to 14 days after initial factor
             VIII exposure during screening

        Exclusion Criteria:

          -  Known hypersensitivities or allergies to murine and/or humanized antibodies

          -  Currently participating in investigational hemophilia studies

          -  HIV infected

          -  Any immunodeficiency disorder

          -  Liver disease and serum ALT or AST is greater than three times the upper limit of
             normal, albumin is less than 2.5g/dl, and/or INR is greater than 1.7

          -  Received interferon or other immunomodulatory drugs, such as steroids or cytotoxic
             therapy in the 30 days prior to study entry

          -  History of cardiac arrhythmias, any active febrile illness, kidney insufficiency, or
             pulmonary infiltrates

          -  Has previously received rituximab treatment

          -  Currently undergoing immune tolerance therapy

          -  Evidence of Hepatitis B (HBV) infection, defined as one of the following:

               -  HBsAg positive

               -  HBsAg negative, HBsAb negative, HBcAb positive, and HBV DNA positive

          -  Participants with a high responding inhibitor (at least 5 BU/mL) first detected fewer
             than 12 months prior to study entry, unless the participant has failed immune
             tolerance therapy, defined as one of the following:

               1. Failure to fulfill the criteria for full or partial success within 33 months, as
                  defined by a factor VIII recovery greater than or equal to 66% of expected and
                  half-life greater than or equal to 6 hours measured after a 72-hour
                  treatment-free washout period

               2. Failure to achieve greater than 20% reduction in inhibitor titer during each
                  interim non-overlapping 6-month period of ITT in the absence of documented
                  infection, with 9 months as the minimum treatment period and 33 months as the
                  maximum possible duration of unsuccessful ITT

               3. Withdrawal from ITT for any other reason

          -  Routinely receive factor VIII concentrate for the treatment of both major and minor
             bleeding events

          -  Has received factor VIII concentrate in the 7 days prior to study entry
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Months old.


Patient description (medical language): A 20-year-old man comes to the emergency due to bleeding after a tooth extraction.  The bleeding has persisted for approximately 30 minutes despite constant direct pressure.  He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%.

Patient description (patient's own words): I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%.

Does the patient match the trial criteria? 1