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Completed

NCT Number: NCT00386425

Evaluate Protein C Levels in Severe Sepsis Patients on Drotrecogin Alfa (Activated)

In this trial, patients with severe sepsis and low protein C levels will receive drotrecogin alfa (activated) at the normal, approved dose and time of administration [24 microgram/kilogram/hour (mcg/kg/hour) for 96 hours] or will receive the normal, approved dose or higher doses than the approved dose for a longer administration time. After the drug administration is complete, the protein C levels from the patients receiving the normal, approved dose will be compared to protein C levels from patients receiving the normal, approved dose or higher dose for a longer duration to determine if the protein C levels improve faster if given higher dose and/or longer administration time.

Note: The protocol was amended to remove the option of shorter infusion durations.

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Key information

Conditions

Severe Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be 18 years or older
  • Must have a suspected or proven infection
  • Must have two or more sepsis-associated organ dysfunctions

Exclusion criteria

  • Documented multiple organ dysfunction greater than 24 hours prior to start of study drug
  • Actual body weight less than 30 kg or more than 135 kg
  • Platelet count less than 30,000/mm^3
  • Active internal bleeding or at increased risk of bleeding
  • Not expected to survive 28 days given the patient's pre-existing uncorrectable medical condition

Treatment and study plan

Drotrecogin Alfa (Activated)

Drug

intravenous

Other names: Xigris, LY203638

Primary outcomes

  1. Mean Change in Protein C Levels From Day 1 to Day 7

    Time frame: Day 1, Day 7

    Mean change in protein C from Study Day 1 to Study Day 7 was tested using an unadjusted two-sample t-test with a two-sided alpha of 0.05. To be included in the primary analysis, Intention-to-Treat (ITT) patients must have at least 1 protein C value available at 24 hours or earlier and at least 1 protein C value at a post-24-hour timepoint.

Secondary outcomes

  1. Mean Change in Protein C Level From Study Day 1 to Study Day 7 in Patients With Moderate and Severe Protein C Deficiency

    Time frame: Day 1, Day 7

    Moderate Protein C Deficiency: A protein C level greater than half the lower limit of normal.

    Severe Protein C Deficiency: A protein C level less than or equal to half the lower limit of normal.

  2. Day 28 All-Cause Mortality

    Time frame: Day 0 through Day 28

  3. Hospital Mortality (up to Day 90)

    Time frame: Day 0 to hospital discharge or Day 90

  4. 28-Day Time Averaged Sequential Organ Failure (SOFA) Score

    Time frame: Day 0, Day 28

    The presence of 5 organ dysfunctions (cardiovascular, respiratory, renal, hepatic, coagulation) was assessed using a Sequential Organ Failure Assessment (SOFA) score. Each organ has a possible dysfunction score of 0 to 4, for a total SOFA score range of 0 (no organ dysfunction) to 20 (all organs with dysfunction). SOFA scores were time-averaged.

  5. Number of Participants With Serious Adverse Events (SAE) and Serious Bleeding Events (SBE) by Time Period

    Time frame: Day 0 through Day 28

    Serious bleeding events (SBE): intracranial hemorrhage, life-threatening or fatal bleed, or bleeding event assessed as an SAE. Patients may have multiple events with onset in different time periods. SAEs include SBEs. The 3 SBEs in Alternative-Moderate Deficiency arm (days 5-8) occurred after completion of study drug infusion. One event (pleural haemorrhage) occurred same day of completion of infusion and 2 events (cerebral haemorrhage, shock haemorrhagic) occurred day after completion.

  6. Mortality by Protein C Normalized Versus Not-normalized

    Time frame: 28 days

    Normalization was defined as having 2 consecutive protein C measurements above the lower limit of normal through Study Day 7.

Other outcomes

  1. Mortality for Severe Protein C Deficiency

    Time frame: 28 Days, up to 90 days

    Twenty-eight day mortality is the patient's mortality status at the predefined timepoint of 672 hours from the start of study drug infusion. Hospital mortality is the patient's survival status at the end of the hospital stay or study day 90 (if the patient remains in the hospital).

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 2 Study to Evaluate Dose and Duration of Treatment of Drotrecogin Alfa (Activated) Using Serial Measurements of Protein C in Patients With Severe Sepsis and Multiple Organ Dysfunction

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Oct 11, 2006
Registry last updated
Dec 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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