Use of Activated Recombinant Human Factor VII to Reduce Bleeding Caused by Warfarin Treatment

Phase 1CompletedNCT01561937

Novo Nordisk A/S127 enrolled

Overview

This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the efficacy of activated recombinant human factor VII to mitigate experimentally-induced bleeding in healthy volunteers treated with warfarin to reach a targeted INR (International Normalization Ratio).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

127

Conditions

Haemostasis Healthy

Interventions

warfarinDRUG

After a baseline punch biopsy (B0), warfarin is administered over a period of approximately 7-14 days. Dose is adjusted individually to achieve INR target. Once a stable INR is achieved, a second biopsy (B1) will be performed

eptacog alfa (activated)DRUG

If the subject is eligible to continue in trial part B, trial drug will be administered i.v. as a slow bolus injection over 2 to 5 minutes in five different doses followed by two biopsies (B2) and (B3) 15 minutes and 5 hours and 15 minutes, respectively, after trial drug administration

placeboDRUG

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * INR below or equal to 1.2 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 14 days prior to trial * African-American race * Weight above 160 kg * Supplemental Vitamin K use

Locations (1)

Novo Nordisk Investigational Site

Overland Park, Kansas, United States

Outcomes

Primary Outcomes

Bleeding duration measured in minutes after biopsies in trial part A

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

Bleeding duration measured in minutes after biopsy B1 in trial part B

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

Secondary Outcomes

Blood volume reported in millilitres after biopsies in trial part A

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

Blood volume reported in millilitres after biopsy B1 in trial part B

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

Adverse events, including thrombotic events

Time frame: From day 0 to days 14-28

Change in coagulation-related parameters after biopsy B1

Time frame: From baseline to 3 hours after B1

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 3 hours after B3

Clot dynamics: R in minutes (trial part B)

Time frame: Time to onset of clot formation

Clot dynamics: K in minutes (trial part B)

Time frame: Time to achieve 20mm clot strength

Data from ClinicalTrials.gov

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