Efficacy and Safety of AlphaNine Versus BeneFIX in Patients With Severe Hereditary Haemophilia B

Hemophilia B Clinical Trial

Official title:

Efficacy and Safety of Factor IX (FIX) Contained in AlphaNine® and Its Pharmacokinetic Comparison With BeneFIX® in Patients With Severe Hereditary Haemophilia B

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03091751
• Other study ID #: IG-404-1
• Status: Completed
• Phase: Phase 2
• First received: March 16, 2017
• Last updated: March 21, 2017
• Start date: August 2005
• Est. completion date: October 2009

Study information

• Verified date: March 2017
• Source: Grifols Biologicals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this non-randomized, multi-center study in subjects with severe hereditary haemophilia B was to determine and compare the pharmacokinetic and safety profiles of BeneFIX in subjects having had 2 prior pharmacokinetic assessments with AlphaNine.

Description:

Two pharmacokinetic assessments (studies) were carried out in the same subjects during a previous clinical trial. The first pharmacokinetic study (PK1) was performed after a single dose of AlphaNine. The second pharmacokinetic study (PK2) was performed following 26 Weeks of AlphaNine treatment after PK1. To compare AlphaNine with BeneFIX, a third pharmacokinetic study (PK3) (current study) was performed after a single dose of BeneFIX administered following a 7- to 15-day wash-out period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemophilia A
• Hemophilia B

Intervention

Drug:
• BeneFIX
BeneFIX is a recombinant FIX that contains nonacog alfa, reconstituted in solvent and administered as a single dose of 65-75 IU/kg.

Locations

Country	Name	City	State
Bulgaria	Medical University Pleven	Pleven
Bulgaria	National Center of Haematology	Sofia
Bulgaria	Medical University, University Hospital "Sveta Marina",	Varna

Sponsors (1)

Lead Sponsor	Collaborator
Grifols Biologicals Inc.

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Factor IX Plasma Activity		Baseline (prior to the infusion), and at 15 and 30 minutes, 1, 3, 6, 9, 24, 48, 50 (optional), 72 and 74 hours after the end of the infusion.