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Clinical Trials/NCT02246894
NCT02246894CompletedPhase 3

An Open Multicentre Phase III Study to Investigate the Safety and Efficacy of Optivate® in Children Under 6 Years of Age With Severe Haemophilia A.

Bio Products Laboratory5 sites in 1 countryStarted: November 1, 2003Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Locations
5
Primary Endpoint
Consumption of FVIII
Study OverviewEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
— to 6 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

  • Not provided

Arms & Interventions

Optivate®

Experimental

Optivate® (Human Coagulation Factor VIII)

Intervention: Optivate® (Human Coagulation Factor VIII) (Biological)

Outcomes

Primary Outcomes

Consumption of FVIII

Time Frame: Day 0 to Week 26

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Bio Products Laboratory
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (5)

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