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:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT03091751
Eligibility Criteria:
Key Inclusion Criteria:
* Participated in the previous study "Efficacy and safety of factor IX (FIX) contained in Alphananine in patients with severe hereditary haemophilia B":
* Congenital deficiency in Factor IX (FIX)
* FIX residual activity of ≤2% of normal
* Had required FIX-containing products in the past and in clinical records that were collected data to assess a reliable estimation of at least 150 treatment exposure days to previous products
* Was able to receive treatment for more than 10 days for a 6-month period
Key Exclusion Criteria:
* Received a dose of FIX in the 7 days prior to the infusion
* FIX inhibitor level of \>0.5 Bethesda units (BU) or clinically relevant presence in the past (≥5 BU)
* Active bleeding at the moment of infusion
* Had a known allergic reaction to any BeneFIX component
* Exhibited symptoms of any intercurrent infection (ie, fever, chills, nausea) at the time of the first infusion
* Had any disease that might affect the distribution or metabolism of FIX and which could affect interpretation of the study (such as non-controlled diabetes mellitus)
* Had non-controlled arterial hypertension
* Had abnormal renal function (creatinine \>1.5 mg/dL)
* Had documented liver cirrhosis or any hepatic disorder with alanine aminotransferase (ALT) levels 2.5x upper limit of normal (ULN )
* Prevision to be concomitantly treated with other FIX-containing products
* Had conditions that might affect subject compliance (survival-limiting \[in 2 year time\] diseases, alcohol or other drug abuse, etc.)
* Unable to provide a storage plasma sample before the first dose of BeneFIX
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT03091751
Study Brief:
Protocol Section:
NCT03091751