Efficacy of Activated Recombinant Human Factor VII in Healthy Volunteers Treated for Punch Biopsy Mediated Bleeding

Phase 1TerminatedNCT01561950

Novo Nordisk A/S91 enrolled

Overview

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®).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Haemostasis Healthy

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

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).

placeboDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * PT/PTT within normal laboratory range (e.g., PT: 9.4-12.0) * Platelet count within normal laboratory range Exclusion Criteria: * 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

Locations (1)

Novo Nordisk Investigational Site

Neptune City, New Jersey, United States

Outcomes

Primary Outcomes

Bleeding duration measured in minutes

Time frame: From onset of bleeding till the end of the bleeding

Secondary Outcomes

Blood volume reported in millilitres

Time frame: From onset of bleeding till the end of the bleeding

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

Time frame: Time to onset of clot formation

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

Time frame: Time to achieve 20 mm clot strength

Adverse events, including thrombotic events

Time frame: From screening to day 11-18

Change in coagulation-related parameters after pre-biopsy

Time frame: From baseline to 15 minutes after pre-biopsy

Change in coagulation-related parameters after biopsy B2

Time frame: From baseline to 3 hours after B2

Change in coagulation-related parameters after biopsy B3

Time frame: From baseline to 1 hour after B3

Data from ClinicalTrials.gov

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