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Effect of Recombinant FVIII in Healthy Male Subjects Treated With TB-402

NCT00612417 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2014-04-07

No results posted yet for this study

Summary

Single administration of recombinant FVIII/placebo in healthy male subjects who have been treated with a single dose of anti-factor VIII antibody, TB-402

Conditions

  • Healthy

Interventions

DRUG

Administration of recombinant FVIII/placebo in healthy male subjects treated with TB-402

Administration of recombinant FVIII/placebo in healthy male subjects treated with TB-402

Sponsors & Collaborators

  • BioInvent International AB

    collaborator INDUSTRY

  • ThromboGenics

    lead INDUSTRY

Principal Investigators

  • Thomas J Jensen, MD, PhD · Cyncron CRU

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2008-03-31
Completion
2008-06-30

Countries

  • Denmark

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 NCT00612417 on ClinicalTrials.gov