Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT02695160
Eligibility Criteria:
Inclusion Criteria:
* Male \>18 years of age
* Severe hemophilia B (native circulating FIX activity \<1%, with or without cross reactive material)
Exclusion Criteria:
* Presence of neutralizing antibodies
* History of hypersensitivity response or an allergic reaction to FIX or FIX products
* Currently receiving long acting FIX replacement therapy
* FIX mutations known to be associated with FIX inhibitors
* Polymorphisms in the ZFN target region
* Presence of any liver mass on MRI, or elevated alpha-fetoprotein (AFP)
* Any contraindication to the use of corticosteroids for immunosuppression
* Currently receiving antiviral therapy for hepatitis B or C or with history or active hepatitis B or hepatitis C or HIV-1 or HIV1/2 antibody positive.
* Chronic anemia, leukopenia, or thrombocytopenia
* Past medical history of active tuberculosis or significant fungal disease
* Symptomatic cardiovascular disease as a co-morbid condition
* Markers of hepatic inflammation or overt or occult cirrhosis
* History of chronic renal disease or creatinine ≥ 1.5 mg/dL
* Systemic (iv or oral) immunomodulatory agent or steroid use (topical treatment is allowed)
* History of chronic infection or other chronic disorder considered an unacceptable risk
* History of malignancy except for treated basal cell or squamous cell carcinoma
* History of alcohol or substance abuse
* Previously received gene therapy product
* Participation in prior investigational drug or medical device study within the previous 3 months
* History of therapeutic non-adherence
* Any other reason that, in the opinion of the Investigator or Medical Monitor, would render the subject unsuitable for participation in the study
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02695160
Study Brief:
Protocol Section:
NCT02695160