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OpenTrials
Completed

NCT Number: NCT02231944

An Open Study to Investigate the Safety and Efficacy of Replenine®-VF in Severe Haemophilia B Patients

To compare the first and second recovery assessments on Replenine®-VF and to evaluate recovery of different batches if patients changed batches during the study.

To evaluate Replenine®-VF in terms of long-term clinical efficacy, tolerance and safety

Completed

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Key information

Conditions

Haemophilia B Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia B Hemorrhagic Disorders

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Klinika Hematologii Instytutu Medycyny Wewnetrznej, Lodz, Poland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Previously treated patients
  • At least 12 years of age
  • Severe Haemophilia B and without inhibitor to factor IX

Exclusion criteria

-

Treatment and study plan

Replenine®-VF (High Purity Factor IX)

Biological

Primary outcomes

  1. Recovery calculated from the first infusion of Replenine®-VF compared with that calculated 12 weeks later.

    Time frame: Baseline and 3 months post-baseline.

    Safety assessments included:

    • assessment of tolerance at injection site
    • assessment of Factor IX inhibitor development
    • assessment of frequency and type of adverse event
    • routine biochemistry and haematology at the start and end of Stage 1 and at the end of the study (Stage 2, if applicable)
    • screening for markers of viral infection at the start and end of each stage of the study (and if patients changed batches).

Sponsors and collaborators

Lead sponsor

Bio Products Laboratory

Other

Registry information

Official study title

An Open Study to Investigate the Safety and Efficacy of Replenine®-VF in Severe Haemophilia B Patients.

Important dates

Study start
1997
Primary completion
2003
First posted
Sep 4, 2014
Registry last updated
Feb 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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