Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis (OASIS)
This study has suspended participant recruitment.
(Data Safety Monitoring Board recommendation)
Sponsor:
Agennix
Information provided by (Responsible Party):
Agennix
ClinicalTrials.gov Identifier:
NCT01273779
First received: January 7, 2011
Last updated: February 2, 2012
Last verified: February 2012
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Purpose
Study will evaluate the safety and potential benefit of talactoferrin (recombinant human lactoferrin) as an addition to the standard care for severe sepsis.
| Condition | Intervention | Phase |
|---|---|---|
|
Severe Sepsis |
Drug: Talactoferrin alfa Drug: Placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | OASIS: A Phase 2/3 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis |
Resource links provided by NLM:
MedlinePlus related topics:
Sepsis
Drug Information available for:
Talactoferrin alfa
U.S. FDA Resources
Further study details as provided by Agennix:
Primary Outcome Measures:
- All Cause Mortality [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- All Cause Mortality [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- All Cause Mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- All Cause Mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Assess Safety and Tolerability [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 1280 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Drug: Placebo
15 mL of oral solution of placebo given 3 times a day for up to 28 days or until discharge from the intensive care unit
|
| Experimental: Talactoferrin alfa |
Drug: Talactoferrin alfa
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 or authorized representatives according to local rules or regulations
- Able to take liquid medication by mouth or feeding tube
Exclusion Criteria:
- 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
- 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
- Chronically bed bound
- Patient, legal representative or patient's primary physician not committed to providing full, aggressive life support
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01273779
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| United States, Alabama | |
| University of Alabama - Birmingham | |
| Birmingham, Alabama, United States, 35249 | |
| Providence Hospital | |
| Mobile, Alabama, United States, 36608 | |
| United States, Arizona | |
| Maricopa Medical Center | |
| Maricopa, Arizona, United States, 85008 | |
| United States, California | |
| St. Joseph Hospital | |
| Orange, California, United States, 92868 | |
| Sharp Memorial Hospital | |
| San Diego, California, United States, 92123 | |
| Stanford University Hospital | |
| Stanford, California, United States, 94305-5117 | |
| UCLA Medical Center | |
| Sylmar, California, United States, 91342 | |
| United States, Colorado | |
| Denver Health Medical Center | |
| Denver, Colorado, United States, 80204 | |
| United States, Delaware | |
| Christiana Care Health Services | |
| Newark, Delaware, United States, 19718 | |
| United States, District of Columbia | |
| George Washington University Hospital | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Bay Area Chest Physicians | |
| Clearwater, Florida, United States, 33756 | |
| United States, Idaho | |
| Eastern Idaho Medical Consultants | |
| Idaho Falls, Idaho, United States, 83404 | |
| United States, Illinois | |
| West Suburban Hospital Medical Center | |
| Oak Park, Illinois, United States, 60302 | |
| Peoria Pulmonary Associates | |
| Peoria, Illinois, United States, 61603 | |
| United States, Indiana | |
| Methodist Research Institute | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| University of Iowa | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Massachusetts | |
| Baystate Medical Center | |
| Springfield, Massachusetts, United States, 01199 | |
| United States, Michigan | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| United States, Missouri | |
| St. Johns Mercy Medical Center | |
| St. Louis, Missouri, United States, 63141 | |
| United States, Nebraska | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198 | |
| United States, New Jersey | |
| Cooper University Hospital | |
| Camden, New Jersey, United States, 08103 | |
| United States, North Carolina | |
| Moses Cone Memorial Hospital | |
| Greensboro, North Carolina, United States, 27401 | |
| Wake Forest University Health Sciences | |
| Winston-Salem, North Carolina, United States, 27517 | |
| United States, Ohio | |
| Riverside Methodist Hospital | |
| Columbus, Ohio, United States, 43214 | |
| St. Vincent Mercy Medical Center | |
| Toledo, Ohio, United States, 43608 | |
| United States, Oklahoma | |
| University of Oklahoma Health Science Center | |
| Oklahoma, Oklahoma, United States, 73104 | |
| United States, Pennsylvania | |
| Cancer Institute, Hillman Cancer Center | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| United States, Tennessee | |
| University of Tennessee | |
| Memphis, Tennessee, United States, 38163 | |
| United States, Texas | |
| Texas Tech Health Science Center | |
| El Paso, Texas, United States, 79905 | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| United States, Utah | |
| LDS Hospital | |
| Murray, Utah, United States, 84157 | |
| United States, Wisconsin | |
| University of Wisconsin Medical School | |
| Madison, Wisconsin, United States, 53792 | |
| Belgium | |
| UZ Brussel | |
| Brussel, Belgium, 1090 | |
| Cliniques Universitaires Saint-Luc | |
| Bruxelles, Belgium, 1200 | |
| Hôpital Erasme | |
| Bruxelles, Belgium, 1070 | |
| Hôpitaux IRIS Sud | |
| Bruxelles, Belgium, 1050 | |
| Ziekenhuis Oost-Limburg | |
| Genk, Belgium, 3600 | |
| UZ Gent | |
| Gent, Belgium, 9000 | |
| CHU de Liège | |
| Liège, Belgium, 4000 | |
| Centre Hospitalier de Dinant | |
| Mons, Belgium, 7000 | |
| Clinique Saint-Pierre | |
| Ottignies, Belgium, 1340 | |
| Cliniques Universitaires UCL de Mont-Godinne | |
| Yvoir, Belgium, 5530 | |
| Canada, British Columbia | |
| Vancouver General Hospital | |
| Vancouver, British Columbia, Canada, V5Z 1M9 | |
| Royal Jubilee Hospital | |
| Victoria, British Columbia, Canada, V8R 1J8 | |
| Canada, Manitoba | |
| Grace Hospital | |
| Winnipeg, Manitoba, Canada, R3J 3M7 | |
| St. Boniface General Hospital | |
| Winnipeg, Manitoba, Canada, R2H 2A6 | |
| Health Sciences Centre | |
| Winnipeg, Manitoba, Canada, R3A 1R9 | |
| Canada, Nova Scotia | |
| Queen Elizabeth II Health Sciences Center | |
| Halifax, Nova Scotia, Canada, B3H 3A7 | |
| Canada, Ontario | |
| Kingston General Hospital | |
| Kingston, Ontario, Canada, K7L 2V7 | |
| Windsor Regional Hospital | |
| Windsor, Ontario, Canada, N8X 3V6 | |
| Canada, Quebec | |
| SMBD - Jewish General Hospital | |
| Montreal, Quebec, Canada, H3T 1C5 | |
| Denmark | |
| Aalborg Sygehus | |
| Aalborg, Denmark, DK-9100 | |
| Odense universitetshospital | |
| Odense, Denmark, DK-5000 | |
| France | |
| Hôtel Dieu | |
| Angers, France, 49933 | |
| Centre Hospitalier Victor Dupouy | |
| Argenteuil, France, 95107 | |
| Centre Hospitalier Départemental La Roche sur Yon, Luçon, Montaigu - Les Oudaries | |
| La Roche sur Yon, France, 85925 | |
| Hôpital Albert Michallon / La Tronche | |
| La Tronche, France, 38700 | |
| Hôpital Universitaire Dupuytren | |
| Limoges, France, 87042 | |
| Centre Hospitalier de Montauban | |
| Montauban, France, 82013 | |
| Hôpital de la Source | |
| Orléans, France, 45067 | |
| Hôpital Cochin | |
| Paris, France, 75679 | |
| Centre Hospitalier Lyon Sud | |
| Pierre Benite, France, 69495 | |
| Hôpital de la Miletrie | |
| Poitiers, France, 86021 | |
| Centre Hospitalier Angouleme | |
| Saint-Michel, France, 16470 | |
| Hôpital Bretonneau | |
| Tours, France, 37044 | |
| Germany | |
| Charité - Universitätsmedizin Berlin | |
| Berlin, Germany, 13353 | |
| Universitätsklinikum Bonn | |
| Bonn, Germany, 53105 | |
| Helios Klinikum Erfurt | |
| Erfurt, Germany, 99089 | |
| Klinikum der Johann-Wolfgang Goethe-Universität | |
| Frankfurt am Main, Germany, 60590 | |
| Klinikum der Friedrich-Schiller-Universität Jena | |
| Jena, Germany, 07747 | |
| Klinikum der Stadt Ludwigshafen gGmbH | |
| Ludwigshafen, Germany, 67063 | |
| Klinikum Harlaching | |
| München, Germany, 81545 | |
| Israel | |
| The Lady Davis Carmel Medical Center | |
| Haifa, Israel, 34362 | |
| Rambam Medical Center | |
| Haifa, Israel, 31096 | |
| Hadassah University Hospital Ein Kerem | |
| Jerusalem, Israel, 91120 | |
| Shaare Zedek Medical Center | |
| Jerusalem, Israel, 91031 | |
| Western Galilee Hospital - Nahariya | |
| Nahariya, Israel, 22100 | |
| Rabin Medical Center | |
| Petach Tikva, Israel, 49100 | |
| Netherlands | |
| Jeroen Bosch Ziekenhuis | |
| 's-Hertogenbosch, Netherlands, 5223 GZ | |
| VU Medisch Centrum | |
| Amsterdam, Netherlands, 1081 HV | |
| Gelre Ziekenhuizen | |
| Apeldoorn, Netherlands, 7334 DZ | |
| Medisch Centrum Leeuwarden | |
| Leeuwarden, Netherlands, 8934 AD | |
| UMC St. Radboud | |
| Nijmegen, Netherlands, 6525 GA | |
| Ikazia Ziekenhuis | |
| Rotterdam, Netherlands, 3083 AN | |
| Spain | |
| Hospital del Mar | |
| Barcelona, Cataluña, Spain, 08003 | |
| Hospital Universitari De Bellvitge | |
| L'Hospitalet de Llobregat, Cataluña, Spain, 08907 | |
| Hospital de Sabadell | |
| Sabadell, Cataluña, Spain, 8208 | |
| Hospital Universitari de Tarragona Joan XXIII | |
| Tarragona, Cataluña, Spain, 43007 | |
| Hospital Mutua de Terrassa | |
| Terrassa, Cataluña, Spain, 08221 | |
| Hospital Universitario La Paz | |
| Madrid, Madrid, Communidad de, Spain, 28046 | |
| Hospital Clinico San Carlos | |
| Madrid, Madrid, Communidad de, Spain, 28040 | |
| Hospital Universitario de Getafe | |
| Getafe, Spain, 28905 | |
| Hospital Universitario La Paz | |
| Madrid, Spain, 28046 | |
| United Kingdom | |
| Aberdeen Royal Infirmary | |
| Aberdeen, United Kingdom, AB25 2ZN | |
| St James's University Hospital | |
| Leeds, United Kingdom, LS9 7TF | |
| St John's Hospital | |
| Livingston, United Kingdom, EH54 6PP | |
| St. Thomas' Hospital | |
| London, United Kingdom, SE1 7EH | |
| University College London | |
| London, United Kingdom, NW1 2BU | |
Sponsors and Collaborators
Agennix
More Information
No publications provided
| Responsible Party: | Agennix |
| ClinicalTrials.gov Identifier: | NCT01273779 History of Changes |
| Other Study ID Numbers: | LF-0802 |
| Study First Received: | January 7, 2011 |
| Last Updated: | February 2, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Agennix:
|
sepsis talactoferrin lactoferrin recombinant human lactoferrin |
Additional relevant MeSH terms:
|
Sepsis Toxemia Infection |
Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |
ClinicalTrials.gov processed this record on June 17, 2013