NCT02246894

Brief Summary

The main objectives of this study are:

  • to assess Optivate® consumption (IU/kg consumed per month for prophylactic and on-demand therapy and dose at each bleed).
  • to assess clinical outcome when treating a bleed with Optivate®.
  • to evaluate Optivate® in terms of clinical tolerance and safety in children under the age of 6 years. .
  • to assess FVIII inhibitor development during the study.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
9.7 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 23, 2014

Completed
Last Updated

February 15, 2018

Status Verified

February 1, 2018

Enrollment Period

1.2 years

First QC Date

September 2, 2014

Last Update Submit

February 14, 2018

Conditions

Haemophilia A

Outcome Measures

Primary Outcomes (1)

  • Consumption of FVIII

    Day 0 to Week 26

Study Arms (1)

Optivate®

EXPERIMENTAL

Optivate® (Human Coagulation Factor VIII)

Biological: Optivate® (Human Coagulation Factor VIII)

Interventions

Optivate® (Human Coagulation Factor VIII)BIOLOGICAL
Optivate®

Eligibility Criteria

AgeUp to 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children under the age of 6 years with a diagnosis of severe Haemophilia A. Subjects who required FVIII therapy and did not demonstrate inhibitors to FVIII.
  • Children with history of inhibitors to FVIII or clinically significant renal or liver disease were not eligible to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Children's Haematology and Oncology Clinic, Ul.

W. Chodzki Str., Lublin Voivodeship, 20-093, Poland

Location

Academic Children's Hospital, Children's Haematology and Oncology, Clinic 265 Wielicka str.

Krakow, 30-663, Poland

Location

Specialist Centre for Medical Care of Mother and Children, Internal Ward 1, 7/8 Dr B. Krysiewicza str.

Poznan, 61-825, Poland

Location

Department of Paediatrics, Haematology and Oncology, Medical University of Warsaw, 24 Marszalkowska str.

Warsaw, 00-576, Poland

Location

Children's Clinic for Bone Marrow Transplant, Oncology and Haematology, Medical University of Wroclaw, 44 Bujwida str.

Wroclaw, 50-345, Poland

Location

Related Links

MeSH Terms

Conditions

Hemophilia A

Interventions

optivateFactor VIII

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Blood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsProtein PrecursorsBiological Factors

Study Design

Study Type
interventional
Phase
phase 3
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2014

First Posted

September 23, 2014

Study Start

November 1, 2003

Primary Completion

January 1, 2005

Last Updated

February 15, 2018

Record last verified: 2018-02

Locations

PL(5)