A Study to Investigate the Safety and Efficacy of Optivat... | NCT02246894

Studies
A Study to Investigate the Safety and Efficacy of Optivate® in Children Under 6 Years of Age With Haemophilia A.

NCT02246894

Sponsor

Bio Products Laboratory

Status

Completed

Last Update Posted

Feb 15, 2018Actual

Enrollment

Not provided

Phase

Phase 3

Conditions

Haemophilia A

Interventions

Optivate® (Human Coagulation Factor VIII)

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2003

Primary Completion Date

Jan 2005Actual

Completion Date

Not provided

First Submitted Date

Sep 2, 2014

First Submission Date that Met QC Criteria

Sep 19, 2014

First Posted Date

Sep 23, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2018

Last Update Posted Date

Feb 15, 2018Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Optivate®	Experimental	Optivate® (Human Coagulation Factor VIII)	Biological: Optivate® (Human Coagulation Factor VIII)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Optivate® (Human Coagulation Factor VIII)	Biological		Optivate®

Measure	Description	Time Frame
Consumption of FVIII		Day 0 to Week 26

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

6 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Haematology and Oncology Clinic, Ul.		W. Chodzki Str.	Lublin Voivodeship	20-093	Poland

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D006467	Hemophilia A

Ancestor Terms

ID	Term
D025861	Blood Coagulation Disorders, Inherited
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C568131	optivate
D005169	Factor VIII

Ancestor Terms

ID	Term
D001779	Blood Coagulation Factors
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided