NCT00386425

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
486

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2006

Geographic Reach
9 countries

47 active sites

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

First Submitted

Initial submission to the registry

October 6, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 11, 2006

Completed
21 days until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

December 16, 2010

Completed
Last Updated

December 16, 2010

Status Verified

November 1, 2010

Enrollment Period

2.8 years

First QC Date

October 6, 2006

Results QC Date

August 26, 2010

Last Update Submit

November 18, 2010

Conditions

Severe Sepsis

Outcome Measures

Primary Outcomes (1)

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

    Day 1, Day 7

Secondary Outcomes (6)

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

    Day 1, Day 7

  • Day 28 All-Cause Mortality

    Day 0 through Day 28

  • Hospital Mortality (up to Day 90)

    Day 0 to hospital discharge or Day 90

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

    Day 0, Day 28

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

    Day 0 through Day 28

  • +1 more secondary outcomes

Other Outcomes (1)

  • Mortality for Severe Protein C Deficiency

    28 Days, up to 90 days

Study Arms (3)

Standard therapy

EXPERIMENTAL

24 microgram/kilogram/hour (mcg/kg/hr) for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours

Drug: Drotrecogin alfa (activated)

Alternative therapy:moderate protein C deficiency

EXPERIMENTAL

24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 48 to 144 hours (original protocol) or an additional 72 to 144 hours (amended protocol)

Drug: Drotrecogin alfa (activated)

Alternative therapy:severe protein C deficiency

EXPERIMENTAL

24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for 48 to 144 hours (original protocol) or an additional 72 to 144 hours (amended protocol)

Drug: Drotrecogin alfa (activated)

Interventions

Drotrecogin alfa (activated)DRUG

intravenous

Also known as: Xigris, LY203638
Alternative therapy:moderate protein C deficiencyAlternative therapy:severe protein C deficiencyStandard therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (47)

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.

Phoenix, Arizona, 85013, United States

Location

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Scottsdale, Arizona, 85258, United States

Location

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Fresno, California, 93701, United States

Location

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Loma Linda, California, 92350, United States

Location

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Stanford, California, 94305, United States

Location

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Washington D.C., District of Columbia, 20037, United States

Location

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Orlando, Florida, 32806, United States

Location

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Idaho Falls, Idaho, 83404, United States

Location

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Indianapolis, Indiana, 46202, United States

Location

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Louisville, Kentucky, 40202, United States

Location

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Portland, Maine, 04102, United States

Location

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Minneapolis, Minnesota, 55455, United States

Location

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St Louis, Missouri, 63141, United States

Location

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Greensboro, North Carolina, 27401, United States

Location

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Abington, Pennsylvania, 19001, United States

Location

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Rapid City, South Dakota, 55701, United States

Location

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Houston, Texas, 77030, United States

Location

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Brussels, 1070, Belgium

Location

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Ghent, 9000, Belgium

Location

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Vancouver, British Columbia, V6Z 1Y6, Canada

Location

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Winnipeg, Manitoba, R2H 2A6, Canada

Location

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Halifax, Nova Scotia, B3H 1V7, Canada

Location

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London, Ontario, N6C 2V5, Canada

Location

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Ottawa, Ontario, K1H 8L6, Canada

Location

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Toronto, Ontario, M4N 3M5, Canada

Location

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Fleurimont, Quebec, J1H 5N4, Canada

Location

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Helsinki, 00290, Finland

Location

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Kuopio, 70211, Finland

Location

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Oulu, 90220, Finland

Location

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Tampere, 33521, Finland

Location

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Angoulême, 16470, France

Location

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La Roche-sur-Yon, 85925, France

Location

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Limoges, 87042, France

Location

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Poitiers, 86021, France

Location

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Tours, 37044, France

Location

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Hamburg, 21075, Germany

Location

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Jena, D-07740, Germany

Location

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Leipzig, D-04103, Germany

Location

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San Juan, 00921, Puerto Rico

Location

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Sabadell, 08208, Spain

Location

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Reading, Berkshire, RG1 5AN, United Kingdom

Location

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Brighton, East Sussex, BN2 5BE, United Kingdom

Location

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Cottingham, East Yorkshire, HU16 5JQ, United Kingdom

Location

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London, Greater London, W6 8RF, United Kingdom

Location

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Waterloo, London, SE1 7EH, United Kingdom

Location

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Kings Lynn, Norfolk, PE30 4ET, United Kingdom

Location

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Birmingham, West Midlands, B9 5SS, United Kingdom

Location

Related Publications (1)

  • Shorr AF, Janes JM, Artigas A, Tenhunen J, Wyncoll DL, Mercier E, Francois B, Vincent JL, Vangerow B, Heiselman D, Leishman AG, Zhu YE, Reinhart K; RESPOND investigators. Randomized trial evaluating serial protein C levels in severe sepsis patients treated with variable doses of drotrecogin alfa (activated). Crit Care. 2010;14(6):R229. doi: 10.1186/cc9382. Epub 2010 Dec 21.

    PMID: 21176144DERIVED

MeSH Terms

Conditions

Sepsis

Interventions

drotrecogin alfa activated

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

Fewer patients than planned had severe PC deficiency so only 2 higher doses were tested \& fewer required longer infusions so a large proportion of alternative therapy patients in effect received standard therapy making treatment comparisons difficult

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 6, 2006

First Posted

October 11, 2006

Study Start

November 1, 2006

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

December 16, 2010

Results First Posted

December 16, 2010

Record last verified: 2010-11

Locations

BE(2)ES(1)GB(7)FI(4)CA(7)US(17)PR(1)FR(5)DE(3)