NCT00612417

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jan 2008

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 11, 2008

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

April 7, 2014

Status Verified

April 1, 2014

Enrollment Period

2 months

First QC Date

January 28, 2008

Last Update Submit

April 4, 2014

Conditions

Healthy

Keywords

Interaction with recombinant FVIII

Outcome Measures

Primary Outcomes (1)

  • Changes in coagulation parameters after rFVIII administration

    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

    To study end

Study Arms (2)

1

EXPERIMENTAL

recombinant FVIII

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

2

PLACEBO COMPARATOR

Placebo

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

Interventions

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

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

12

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cyncron CRU

Copenhagen, DK-2100, Denmark

Location

MeSH Terms

Interventions

TB 402

Study Officials

  • Thomas J Jensen, MD, PhD

    Cyncron CRU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2008

First Posted

February 11, 2008

Study Start

January 1, 2008

Primary Completion

March 1, 2008

Study Completion

June 1, 2008

Last Updated

April 7, 2014

Record last verified: 2014-04

Locations

DK(1)