Clinical trial: Hemophilia Inhibitor Clinical Trials (INHIBIT) Platform (NCT02196207)

Eligibility criteria:
Prevention Trial, Inclusion Criteria:

          -  Male children >/= 4 months of age.

          -  Severe hemophilia A (FVIII < 0.01 U/ml)

          -  No previous bleed or surgery requiring treatment (except circumcision)

          -  No previous factor VIII product (except for circumcision)

          -  Willingness to comply with weekly prophylaxis for 48 weeks

          -  Willingness of parent/caregiver to keep a personal diary of bleeding frequency and
             factor treatment.

          -  Willingness to make monthly visits and coagulation testing at weeks 4, 12, 24, 36, and
             48 (end of study)

        Prevention Trial, Exclusion Criteria:

          -  Acquired hemophilia.

          -  Any bleeding disorder other than hemophilia A.

          -  Treatment with clotting factor previously, other than circumcision.

          -  Presence of an inhibitor to factor VIII.

          -  Use of an experimental drug(s).

          -  Surgery anticipated in the next 48 weeks.

          -  Life expectancy less than 5 years.

          -  Inability to comply with study requirements.

        Eradication Trial, Inclusion Criteria:

          -  Male adults or children with no age limitation.

          -  Severe hemophilia A (FVIII <0.01 U/ml).

          -  Presence of an inhibitor to FVIII (anti-FVIII > 5.0 B.U.)

          -  Willingness to comply with study drugs for up to 48 weeks.

          -  Willingness to keep a personal diary of bleed frequency and drug treatment.

          -  Willingness to make monthly visits and coagulation testing at weeks 4, 12, 24, 36, and
             48 (end of study).

        Eradication Trial, Exclusion Criteria:

          -  Acquired hemophilia.

          -  Any bleeding disorder other than hemophilia A.

          -  Current use of Emicizumab, or if used, > 8 weeks since last treatment.

          -  Use of an experimental drug(s).

          -  Surgery anticipated in the next 48 weeks.

          -  Life expectancy less than 5 years.

          -  Inability to copy with study requirements.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 4 Months old.
Subject must be at most 99 Years

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? Contradiction