Clinical Trials Logo
  1. Home
  2. Haemophilia B
  3. NCT02250573
  4. Details
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
See also
  Status Clinical Trial Phase
Completed NCT03660774 - A Study of the Impact of Hemophilia and Its Treatment on Brain Development, Thinking and Behaviour in Children With Hemophilia
Completed NCT02568202 - Bridging Hemophilia B Experiences, Results and Opportunities Into Solutions (B-HERO-S) N/A
Completed NCT01949792 - A Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa in Patients With Haemophilia A or B With or Without Inhibitors Phase 1
Completed NCT01562587 - Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B in a Non- Bleeding State Phase 1
Completed NCT03655340 - A Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B in France
Completed NCT03276130 - Management of Health-Related QoL Impairment, Including Pain, Depression and Anxiety, in People With Haemophilia A and B
Completed NCT01228669 - Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or B Phase 1
Completed NCT01988532 - Impact of Pain on Functional Impairment and Quality of Life in Adults With Hemophilia N/A
Completed NCT01234545 - Observational Study Describing the Usual Clinical Practice Use of NovoSeven® in the Home Treatment of Joint Bleeds in Patients With Haemophilia A or B and Inhibitors N/A
Enrolling by invitation NCT03690336 - Adverse Event Data Collection From External Registries on Nonacog Beta Pegol
Completed NCT02241694 - To Quantify the Range of Main Psychosocial Factors Affecting Patients and Caregivers in Their Daily Lives N/A
Completed NCT01220141 - Observational Study on Safety of Room Temperature Stable NovoSeven® in Patients With Haemophilia A or B N/A
Completed NCT01562457 - Intra-subject Variability Following Administrations of Activated Recombinant Human Factor VII in Haemophilia Patients in a Non-bleeding State Phase 1
Completed NCT03055611 - A Study to Evaluate the Real-world Usage and Effectiveness of Elocta and Alprolix in Patients With Haemophilia A or B
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
Completed NCT03075670 - A Trial Comparing Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B Phase 1
Completed NCT02300519 - Thrombin Generation Numerical Models Validation in Haemophilic Case N/A
Withdrawn NCT02084810 - Investigating the Bioequivalence of Eptacog Alfa A 6 mg and NovoSeven® in Healthy Male Subjects Phase 1
Completed NCT02049099 - A Non-interventional Retrospective Study of the Current Treatment Practice in European Haemophilia Care N/A

External Links