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GS1191 Clinical Trials for Hemophilia A,Recruiting

Study: Clinical exploration of adeno-associated virus vector expression of human coagulation factor VIII gene therapy for hemophilia A
Location:Tianjin, Blood Diseases Hospital of Chinese Academy of Medical Sciences


Please contact the department if you are willing to participate in a trial and meet the following criteria.

Basic inclusion criteria:
  • 1

    Understand the study objectives and risks and sign informed consent forms according to national and local privacy laws;

  • 2

    Males subjects and ≥ 18 years of age;

  • 3

    Meet the requirements for detecting endogenous FVIII activity levels;

  • 4

    Have had ≥150 prior exposure days (EDs) to any recombinant and/or plasma-derived FVIII protein products;

  • 5

    Subjects for prophylaxis: people who need at least three times of exogenous FVIII treatment for hemorrhagic attack in the past 52 weeks (spontaneous or traumatic)

  • 6

    No history of hypersensitivity or anaphylaxis associated with FVIII product administration;

  • 7

    Have no measurable FVIII inhibitor as assessed by laboratory two times that were at least one week apart; or documented no prior history of FVIII inhibitor after 150 EDs and no clinical signs or symptoms of decreased response to FVIII infusion;

  • 8

    Have acceptable laboratory values of hematology, kidney function, liver function and blood coagulation function sampled at screening and repeated prior to Day 0;

  • 9

    Agree to use reliable barrier contraception until the end of the observation period and laboratory test when required;

Contact Person

Mrs. Zhou

Contact Time

9:00-11:00,14:00-17:00 on working days