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Completed

NCT Number: NCT00612417

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

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

Completed

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Cyncron CRU

Copenhagen, DK-2100, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

include:

  • Males 18 to 45 years of age
  • Healthy according to medical history, physical exam, ECG, blood pressure and heart rate, and laboratory profile of blood and urine

Exclusion criteria

include:

  • Self or family history of cardiovascular or pulmonary disorder, or coagulation or bleeding disorders or reasonable suspicion of vascular malformations e.g. cerebral haemorrhage, aneurysm or premature stroke
  • History of important bleeding episodes
  • Previous allergic reaction to immunoglobulin
  • Present or previous history of severe allergy, for example asthma or anaphylactic reactions
  • FVIII:C <50% or >150% at screening
  • Clinically significant out of range values for any coagulation test during screening
  • Received prescribed medication, over the counter medication or herbal medicines within 14 days of receipt of TB-402

Treatment and study plan

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

Drug

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

Primary outcomes

  1. Changes in coagulation parameters after rFVIII administration

    Time frame: To study end

Secondary outcomes

  1. PD of TB-402, safety of TB-402 alone and with rFVIII, PK of FVIII in rFVIII-treated subjects, changes in coagulation parameters after TB-402 administration

    Time frame: To study end

Sponsors and collaborators

Lead sponsor

ThromboGenics

Industry

Collaborators

  • BioInvent International AB

Registry information

Official study title

A Randomised, Double-blind and Placebo-controlled Study Investigating the Pharmacodynamic Effects of Administration of Recombinant Human Factor VIII in Healthy Male Subjects Treated With the Monoclonal Anti-factor VIII Antibody, TB-402

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Feb 11, 2008
Registry last updated
Apr 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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