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NCT02250573 Clinical Trial

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

Haemophilia B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02250573
Other study ID # R9VFSUR
Secondary ID
Status Completed
Phase Phase 3
First received September 2, 2014
Last updated February 20, 2018
Start date December 2005

Study information
Verified date February 2018
Source Bio Products Laboratory
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date April 2006
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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:

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Replenine®-VF (High Purity Factor IX)

Locations
Country Name City State
Poland Samodzielny Publiczny Zaklad Opieki Zdrowotnej nad Matka I Dzieckiem, ul. Krysiewicza 7/8. Poznan
Romania Institutul National de Haemtologie, 2-8 Constantin Caracas Str. Bucharest
Romania Spitalul de urgenta pentru copii "Louis Turcana", Str. losef Nemoianu 2. Timisoara
Russian Federation Kirov Research Institute of Haematology, 72 Krasnoarmeyskaya ul. Kirov
Russian Federation Haematology Centre, Russian Academy if Medical Sciences, 4a Novozykovsky Proezed. Moscow

Sponsors (1)
Lead Sponsor Collaborator
Bio Products Laboratory

Countries where clinical trial is conducted

Poland,  Romania,  Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incremental recovery for Factor IX Incremental recovery is defined as peak rise in plasma Factor IX levels divided by Factor IX dose in IU/KG 90 min post-dose
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Active, not recruiting NCT05365217 - A Research Study Investigating Nonacog Beta Pegol (N9-GP) for Treatment and Prevention of Bleedings in Chinese People With Haemophilia B Phase 3
Completed NCT01467427 - Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B. Phase 3
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Completed NCT02300519 - Thrombin Generation Numerical Models Validation in Haemophilic Case N/A
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