Severe SepsisPhase 2NCT00630656
Safety and Efficacy Study of Recombinant Human Lactoferrin to Treat Severe Sepsis
A Phase 2 study testing Talactoferrin alfa in people with Severe Sepsis, run by Agennix at 34 sites in 5 countries.
Trial summary
Study will evaluate the safety and potential benefit of recombinant human talactoferrin as an addition to the standard care of severe sepsis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Sepsis
- What is being tested?
- Talactoferrin alfa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 34 sitesin 5 countries
- Study dates
- Apr 2008to Feb 2010
- Phase
- Phase 2
- 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
- Age greater than or equal to 18 years
- Onset of severe sepsis within the previous 24 hours
- Must be receiving antibiotic therapy
- Informed consent form signed by patient, legal next-of-kin or legal guardian
- Able to take medication by mouth or feeding tube
Who cannot join
- Receipt of investigational medication within 4 weeks prior to participation in the study
- Pregnant or breast-feeding
- Severe congestive heart failure
- Known severe HIV infection
- Presence of severe burns
- Patients on high dose immunosuppressants
Show all 11Show fewer
- Patients whose death is considered imminent
- Patients whose life expectancy for concurrent illness is less than 6 months
- Severe hypoxic encephalopathy or persistent vegetative state
- Severe liver disease
- Patient, legal representative or patient's primary physician not committed to providing full, aggressive life support
Trial locations and contacts
34 sites in 5 countries.
34 sites in 5 countries
United States27 sites
Cooper University Hospital
Camden, New Jersey, 08103
Rush University Medical Center
Chicago, Illinois, 60612
Denver Health Medical Center
Denver, Colorado, 80204
Henry Ford Health System
Detroit, Michigan, 48202
Duke University Medical Center
Durham, North Carolina, 27710
Texas Tech University Health Sciences Center
El Paso, Texas, 79905
Ben Taub General Hospital
Houston, Texas, 77030
The Methodist Hospital
Houston, Texas, 77030
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of Iowa Hospitals and Clinic
Iowa City, Iowa, 52242
University of Kansas Medical Center
Kansas City, Kansas, 66160
Loma Linda University Medical Center
Loma Linda, California, 92354
Floyd Memorial Hospital and Health Services
New Albany, Indiana, 47105
West Suburban Medical Center
Oak Park, Illinois, 60302
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104
University of Pittsburgh Medical Center Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
Rhode Island Hospital
Providence, Rhode Island, 02903
UC Davis Medical Center
Sacramento, California, 95817
Intermountain Medical Center
Salt Lake City, Utah, 84143
Baystate Medical Center
Springfield, Massachusetts, 01199
St. Louis University
St Louis, Missouri, 63110
St. John's Mercy Medical Center
St Louis, Missouri, 63141
Olive View- UCLA Medical Center
Sylmar, California, 91342
Scott & White Memorial Hospital
Temple, Texas, 76508
The George Washington University Hospital
Washington D.C., District of Columbia, 20037
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27517
Canada2 sites
Kingston General Hospital
Kingston, Ontario, K7L 2V7
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
France2 sites
Centre Hospitalier de Montauban
Montauban, 82013
Centre Hospitalier Angouleme
Saint-Michel, 16470
Spain2 sites
Hospital de Sabadell
Sabadell, Catalonia, 08208
Hospital Mutua de Terrassa
Terrassa, Catalonia, 08221
About this study
Official title: A Phase 2 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis
Study will evaluate the safety and potential benefit of recombinant human talactoferrin as an addition to the standard care of severe sepsis.
- Conditions
- Severe Sepsis
- Being tested
- Talactoferrin alfa, Placebo
- Keywords
- sepsis, talactoferrin, lactoferrin, recombinant human lactoferrin
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Talactoferrin alfaDrug
15 mL of an oral solution of 100mg/mL (1.5 g) given 3 times a day for up to 28 days or until discharge from the intensive care unit
PlaceboDrug
Placebo given 3 times a day for up to 28 days or until discharge from the intensive care unit
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Talactoferrin alfa Receives: Drug: Talactoferrin alfa |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: 28-day
Secondary outcomes (2)
All-cause mortality
Measured: 3 months
All-cause mortality
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startApr 2008
- Primary completionAug 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agennix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kalpalatha K Guntupalli, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00630656
- Sponsor's protocol ID
- LF-0801
- Other IDs
- NIH grant 1R44GM077816-01A2
- Status last verified
- Aug 2011
- First submitted
- 28 Feb 2008
- Last updated
- 23 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Guntupalli K, Dean N, Morris PE, Bandi V, Margolis B, Rivers E, Levy M, Lodato RF, Ismail PM, Reese A, Schaumberg JP, Malik R, Dellinger RP; TLF LF-0801 Investigator Group. A phase 2 randomized, double-blind, placebo-controlled study of the safety and efficacy of talactoferrin in patients with severe sepsis. Crit Care Med. 2013 Mar;41(3):706-16. doi: 10.1097/CCM.0b013e3182741551.
PubMed 23425819
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis
- ClinicalTrials.gov ID
- NCT00630656
- Acronym / sponsor ID
- LF-0801
- Conditions
- Severe Sepsis
- Keywords
- sepsis, talactoferrin, lactoferrin, recombinant human lactoferrin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- AgennixIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 7 Mar 2008 (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.
Study will evaluate the safety and potential benefit of recombinant human talactoferrin as an addition to the standard care of severe sepsis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Talactoferrin alfaTalactoferrin alfa |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age greater than or equal to 18 years
- Onset of severe sepsis within the previous 24 hours
- Must be receiving antibiotic therapy
- Informed consent form signed by patient, legal next-of-kin or legal guardian
- Able to take medication by mouth or feeding tube
Key exclusion criteria (11 listed)
- Receipt of investigational medication within 4 weeks prior to participation in the study
- Pregnant or breast-feeding
- Severe congestive heart failure
- Known severe HIV infection
- Presence of severe burns
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 |
|---|---|---|
| Talactoferrin alfa15 mL of an oral solution of 100mg/mL (1.5 g) given 3 times a day for up to 28 days or until discharge from the intensive care unit | Drug | 1 |
| PlaceboPlacebo given 3 times a day for up to 28 days or until discharge from the intensive care unit | Drug | 2 |
Primary outcome
All-cause mortality
Time frame: 28-day
2 secondary outcomes
All-cause mortality
Time frame: 3 months
All-cause mortality
Time frame: 6 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 23 Aug 2011.
- Derived from this study: PubMed 23425819Guntupalli K, Dean N, Morris PE, Bandi V, Margolis B, Rivers E, Levy M, Lodato RF, Ismail PM, Reese A, Schaumberg JP, Malik R, Dellinger RP; TLF LF-0801 Investigator Group. A phase 2 randomized, double-blind, placebo-controlled study of the safety and efficacy of talactoferrin in patients with severe sepsis. Crit Care Med. 2013 Mar;41(3):706-16. doi: 10.1097/CCM.0b013e3182741551.
Related trials for Severe Sepsis
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
Not yet recruitingObservational study
Blood Pressure Goal in Preterm Preeclampsia
Hypertensive Disorder of Pregnancy, Preeclampsia
Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
EBV Viremia, CMV Viremia
Recruiting
Efficacy and Safety of Methylene Blue in the Treatment of Severe Septic Shock
Septic Shock, Methylene Blue
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.
Kalpalatha K Guntupalli, MD principal investigator
Baylor College of Medicine
34 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Talactoferrin alfa in people with Severe Sepsis, run by Agennix at 34 sites in 5 countries.
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 5 inclusion and 11 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 23 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Canada, France, Spain, Germany. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
All-cause mortality (time frame: 28-day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00630656, which also lists 1 linked publication.
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 23 Aug 2011.