NCT01128881

IMMUNINE Pre-Treatment Study

IMMUNINE - Purified Factor IX Concentrate Virus-Inactivated: A Phase 4, Prospective, Open-label Multicenter Study to Prospectively Document the Exposure of IMMUNINE and to Monitor FIX Inhibitors in Previously Treated Patients With Severe (FIX Level < 1%) or Moderately Severe (FIX Level <= 2%) Hemophilia B Who Are Planned to Enter BAX 326 Study 250901 to Investigate a New Recombinant FIX Concentrate

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Baxalta now part of Shire · Industry
• Sex: All
• Age: 64 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to prospectively document the exposure to IMMUNINE and to monitor FIX inhibitors over a period of approximately 20 to 50 exposure days while receiving prophylactic treatment in up to 50 previously treated patients (PTPs) aged 12-64 years and approximately 20 pediatric PTPs up to 11 years of age with severe (FIX level \< 1%) or moderately severe (FIX level \<= 2%) hemophilia B who are planned to enter BAX326 study 250901, provided all eligibility criteria are met. In addition, this study will evaluate the efficacy, safety, immunogenicity, thrombogenicity, and health-related quality of life (HR QoL) of these subjects.

Conditions

• Hemophilia B

Interventions

Type	Name	Description
BIOLOGICAL	Factor IX Concentrate (purified, virus-inactivated)	Intravenous injection/infusion; dose for prophylaxis: 20-40 IU/kg bodyweight, twice weekly (which may be adjusted to the subject´s bleeding pattern and lifestyle); dose for bleeding episodes and surgery: according to the Summary of Product Characteristics and the Product Information Leaflet of the respective country.

Timeline

• Start date: 2010-05-31
• Primary completion: 2012-08-28
• Completion: 2012-08-28
• First posted: 2010-05-24
• Last updated: 2021-04-23

Locations

18 sites across 10 countries: Argentina, Brazil, Bulgaria, Chile, Colombia, Czechia, Poland, Romania, Russia, Ukraine