An Open-study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Subjects Undergoing Surgery

NCT ID: NCT02250573

Last Updated: 2018-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Brief Summary

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The main objectives of this study were to investigate the safety and efficacy of Replenine®-VF administered in appropriate dosage by bolus infusion to prevent bleeding and achieve haemostasis in subjects with haemophilia B undergoing surgery.

Detailed Description

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Conditions

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Haemophilia B

Study Design

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Primary Study Purpose

TREATMENT

Study Groups

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Replenine®-VF

Group Type EXPERIMENTAL

Replenine®-VF (High Purity Factor IX)

Intervention Type BIOLOGICAL

Interventions

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Replenine®-VF (High Purity Factor IX)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Subjects with moderate to severe haemophilia B undergoing major surgery requiring an in-patient stay of generally 5 to 10 days.

Exclusion Criteria

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bio Products Laboratory

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Samodzielny Publiczny Zaklad Opieki Zdrowotnej nad Matka I Dzieckiem, ul. Krysiewicza 7/8.

Poznan, , Poland

Site Status

Institutul National de Haemtologie, 2-8 Constantin Caracas Str.

Bucharest, , Romania

Site Status

Spitalul de urgenta pentru copii "Louis Turcana", Str. losef Nemoianu 2.

Timișoara, , Romania

Site Status

Kirov Research Institute of Haematology, 72 Krasnoarmeyskaya ul.

Kirov, , Russia

Site Status

Haematology Centre, Russian Academy if Medical Sciences, 4a Novozykovsky Proezed.

Moscow, , Russia

Site Status

Countries

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Poland Romania Russia

Related Links

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Other Identifiers

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R9VFSUR

Identifier Type: -

Identifier Source: org_study_id

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