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Study of the Efficacy of Human Recombinant Factor VIII (Kogenate FS) Reconstituted in Pegylated Liposomes.

NCT00245297 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2007-10-16

No results posted yet for this study

Summary

Primary efficacy endpoint: To study whether there is a difference in the length of the bleeding free periods between infusion of FVIII that is reconstituted with 22.1, 12.6, or 4.2 mg of pegylated liposomes per kg bwt compared with standard formulation.

Safety endpoint: To study the safety and tolerability of Kogenate FS reconstituted with Pegylated liposomes

Conditions

  • Haemophilia A

Interventions

DRUG

Kogenate FS, reconstituted in a suspension of liposomes

Sponsors & Collaborators

  • Recoly N.V.

    lead INDUSTRY

Principal Investigators

  • Jack Spira, MD. PhD. · Recoly C/o InSpira Medical AB, Nasbyv 38, 13553 Tyreso Sweden

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Completion
2006-04-30

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00245297 on ClinicalTrials.gov