Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 64 of 79996 for:    subjects

Effects of LMWH in Healthy Subjects Treated With TB-402 and Effects of TB-402 in Healthy Subjects Treated With Warfarin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00618579
Recruitment Status : Completed
First Posted : February 20, 2008
Last Update Posted : April 7, 2014
Sponsor:
Collaborator:
BioInvent International AB
Information provided by (Responsible Party):
ThromboGenics

Brief Summary:
Administration of LMWH in healthy male subjects treated with TB-402 and administration of TB-402 in healthy male subjects treated with warfarin

Condition or disease Intervention/treatment Phase
Healthy Drug: LWMH in TB-402 treated subjects or TB-402 in warfarin treated subjects Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: A Randomised, Controlled Study Investigating the Safety and Anticoagulant Activity of Administration of Low-molecular-weight Heparin in Healthy Male Subjects Treated With the Monoclonal Anti-factor VIII Antibody, TB-402 and the Safety and Anticoagulant Activity of Administration of TB-402 in Healthy Male Subjects Treated With Warfarin
Study Start Date : February 2008
Actual Primary Completion Date : June 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Experimental: LMWH arm - active LMWH Drug: LWMH in TB-402 treated subjects or TB-402 in warfarin treated subjects
Administration of LMWH in healthy male subjects treated with TB-402 and administration of TB-402 in healthy male subjects treated with warfarin

Placebo Comparator: LMWH arm - placebo Drug: LWMH in TB-402 treated subjects or TB-402 in warfarin treated subjects
Administration of LMWH in healthy male subjects treated with TB-402 and administration of TB-402 in healthy male subjects treated with warfarin

Experimental: Warfarin arm - active warfarin Drug: LWMH in TB-402 treated subjects or TB-402 in warfarin treated subjects
Administration of LMWH in healthy male subjects treated with TB-402 and administration of TB-402 in healthy male subjects treated with warfarin

Warfarin arm - control Drug: LWMH in TB-402 treated subjects or TB-402 in warfarin treated subjects
Administration of LMWH in healthy male subjects treated with TB-402 and administration of TB-402 in healthy male subjects treated with warfarin




Primary Outcome Measures :
  1. Anticoagulant activity assessed by aPTT, PT, TGAs and FVIII:c [ Time Frame: To study end ]

Secondary Outcome Measures :
  1. Changes in safety parameters over time, PK parameters estimated by NCA, effect of LMWH in TB-402 treated subjects assessed by anti factor Xa (LMWH arm) [ Time Frame: To study end ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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% 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00618579


Locations
Layout table for location information
Denmark
Cyncron CRU
Copenhagen, Denmark
Sponsors and Collaborators
ThromboGenics
BioInvent International AB
Investigators
Layout table for investigator information
Principal Investigator: Thomas J Jensen, MD, PhD Cyncron CRU

Layout table for additonal information
Responsible Party: ThromboGenics
ClinicalTrials.gov Identifier: NCT00618579     History of Changes
Other Study ID Numbers: TB-402-003
First Posted: February 20, 2008    Key Record Dates
Last Update Posted: April 7, 2014
Last Verified: April 2014

Keywords provided by ThromboGenics:
Interaction with LMWH or warfarin

Additional relevant MeSH terms:
Layout table for MeSH terms
Warfarin
Anticoagulants