SepsisPhase 4NCT00067730
A Safety Evaluation of Drotrecogin Alfa (Activated) in Patients With Blood Cancer, Severe Infection Related to Bone Marrow Transplantation
A Phase 4 study testing Drotrecogin Alfa (activated) in people with Sepsis and Hematologic Neoplasms, run by Eli Lilly and Company at 5 sites in United States.
Trial summary
The purpose is to determine how Drotrecogin Alfa (activated) will affect patients with blood cancers who develop severe sepsis within 60 days of starting chemotherapy in preparation for bone marrow transplant (BMT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Hematologic Neoplasms, Hematopoietic Stem Cell Transplantation
- What is being tested?
- Drotrecogin Alfa (activated)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2003to Oct 2003
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have Leukemia, Lymphoma or Myeloma.
- Participants must have had hematopoietic stem cell transplantation(HSCT) within the past 60 days.
- Participants must have infection with either vasopressor dependent septic shock or ventilator-dependent respiratory failure.
- Participants must be on a breathing machine or require medication to maintain their blood pressure.
Who cannot join
- Participants must not have increased bleeding risk due to medical conditions or medications.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
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.
Denver, Colorado
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.
Durham, North Carolina
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.
Iowa City, Iowa
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.
Manhassaet, New York
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.
Winston-Salem, North Carolina
About this study
Official title: A Safety Evaluation of Xigris Drotrecogin Alfa Activated in Hematopoietic Stem Cell Transplant Patients With Severe Sepsis
The purpose is to determine how Drotrecogin Alfa (activated) will affect patients with blood cancers who develop severe sepsis within 60 days of starting chemotherapy in preparation for bone marrow transplant (BMT).
Read the detailed description
The purpose of this study is to determine how Drotrecogin Alfa (activated) will affect leukemia, lymphoma and myeloma patients who develop sever sepsis within 60 days of starting chemotherapy in preparation for bone marrow transplant (BMT). The study will evaluate the safety of Xigris by assessing the risk of serious bleeding events, including bleeding within the brain and serious bleeding leading to death.
- Being tested
- Drotrecogin Alfa (activated)
- Medical subject headings
- Sepsis, Hematologic Neoplasms, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drotrecogin Alfa (activated)Drug
Also called LY203638, Xigris
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 24 microgram/kg/hr for 96 hours (+ or - 1 hour) Receives: Drug: Drotrecogin Alfa (activated) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Measured: 10 months
Secondary outcomes (2)
Mortality
Measured: 10 months
Bleeding incidence
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2003 (estimated)
- Study startMar 2003
- Study completionOct 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00067730
- Sponsor's protocol ID
- 6416
- Other IDs
- F1K-US-EVCE
- Status last verified
- Dec 2007
- First submitted
- 25 Aug 2003
- Last updated
- 7 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety Evaluation of Xigris Drotrecogin Alfa Activated in Hematopoietic Stem Cell Transplant Patients With Severe Sepsis
- ClinicalTrials.gov ID
- NCT00067730
- Acronym / sponsor ID
- 6416
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Study completion
- Oct 2003 (actual)
- First posted
- 27 Aug 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose is to determine how Drotrecogin Alfa (activated) will affect patients with blood cancers who develop severe sepsis within 60 days of starting chemotherapy in preparation for bone marrow transplant (BMT).
Detailed description
The purpose of this study is to determine how Drotrecogin Alfa (activated) will affect leukemia, lymphoma and myeloma patients who develop sever sepsis within 60 days of starting chemotherapy in preparation for bone marrow transplant (BMT). The study will evaluate the safety of Xigris by assessing the risk of serious bleeding events, including bleeding within the brain and serious bleeding leading to death.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Drotrecogin Alfa (activated)24 microgram/kg/hr for 96 hours (+ or - 1 hour) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must have Leukemia, Lymphoma or Myeloma.
- Participants must have had hematopoietic stem cell transplantation(HSCT) within the past 60 days.
- Participants must have infection with either vasopressor dependent septic shock or ventilator-dependent respiratory failure.
- Participants must be on a breathing machine or require medication to maintain their blood pressure.
Key exclusion criteria (1 listed)
- Participants must not have increased bleeding risk due to medical conditions or medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drotrecogin Alfa (activated)Also: LY203638, Xigris | Drug | 1 |
Primary outcome
Safety
Time frame: 10 months
2 secondary outcomes
Mortality
Time frame: 10 months
Bleeding incidence
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2007.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Drotrecogin Alfa (activated) in people with Sepsis and Hematologic Neoplasms, run by Eli Lilly and Company at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2007; AzTrials last refreshed its copy on 8 Nov 2026.