NCT01561950

Brief Summary

This trial is conducted in the United States of the America (USA). The aim of this trial is to evaluate the effectiveness of activated recombinant human factor VII to mitigate experimentally-induced bleeding in healthy volunteers treated with clopidogrel (Plavix®).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
91

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

May 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2012

Completed
Last Updated

November 23, 2016

Status Verified

November 1, 2016

Enrollment Period

8 months

First QC Date

March 21, 2012

Last Update Submit

November 22, 2016

Conditions

HaemostasisHealthy

Outcome Measures

Primary Outcomes (1)

  • Bleeding duration measured in minutes

    From onset of bleeding till the end of the bleeding

Secondary Outcomes (7)

  • Blood volume reported in millilitres

    From onset of bleeding till the end of the bleeding

  • Clot dynamics on the TEG (thromboelastograph hemostasis analyzer): R in minutes

    Time to onset of clot formation

  • Clot dynamics on the TEG (thromboelastograph hemostasis analyzer): K in minutes

    Time to achieve 20 mm clot strength

  • Adverse events, including thrombotic events

    From screening to day 11-18

  • Change in coagulation-related parameters after pre-biopsy

    From baseline to 15 minutes after pre-biopsy

  • +2 more secondary outcomes

Study Arms (2)

Factor VII

EXPERIMENTAL
Drug: eptacog alfa (activated)Drug: clopidogrel

Placebo

PLACEBO COMPARATOR
Drug: clopidogrelDrug: placebo

Interventions

eptacog alfa (activated)DRUG

If subject is eligible to continue after clopidogrel treatment, three different doses of trial drug is administered i.v. as a slow bolus injection over two to three minutes followed by post-trial biopsies

Also known as: activated recombinant human factor VII
Factor VII
clopidogrelDRUG

Following a baseline biopsy (B0) subjects will receive oral treatment with an initial 300 mg loading dose followed by daily 75 mg doses for at least 3 additional days. If the target platelet inhibition (PI) is achieved, the subject will undergo punch biopsy 1 (B1).

Factor VIIPlacebo
placeboDRUG

If subject is eligible to continue after clopidogrel treatment, three different doses of trial drug is administered i.v. as a slow bolus injection over two to three minutes followed by post-trial biopsies

Placebo

Eligibility Criteria

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

You may qualify if:

  • PT/PTT within normal laboratory range (e.g., PT: 9.4-12.0)
  • Platelet count within normal laboratory range

You may not qualify if:

  • The receipt of any investigational drug within 1 month prior to this trial
  • Use of anticoagulation therapy-defined as vitamin K antagonists, platelet antagonists, heparin
  • (or low molecular weight heparin), aspirin or NSAIDs (non-steroidal anti-inflammatory drug) within 30 days prior to trial
  • African-American race
  • Weight above or equal to 160 kg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Neptune City, New Jersey, 07753, United States

Location

Related Links

MeSH Terms

Interventions

Factor VIIClopidogrel

Intervention Hierarchy (Ancestors)

Enzyme PrecursorsEnzymes and CoenzymesBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsProtein PrecursorsBiological FactorsTiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

March 21, 2012

First Posted

March 23, 2012

Study Start

May 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

November 23, 2016

Record last verified: 2016-11

Locations

US(1)