Ronald Pearl
Study to see if ART-123 (recombinant human soluble thrombomodulin) decreases the number of people who die as a result of Disseminated Intravascular Coagulation (DIC) complication of sepsis.
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
You are invited to participate in a research study of the safety and effectiveness of an experimental drug Art-123 (a soluble recombinant human thrombomodulin) due to your current illness. Your doctor believes you have sepsis (severe form of infection). With sepsis you may develop a condition called DIC (Disseminated Intravascular Coagulation). DIC is a complication of many serious diseases including sepsis, cancer and trauma. It interferes with platelets and other parts of the blood that help prevent clotting. As a result, small clots can develop (microthrombi). This can then affect the heart, lungs, liver and brain function. Mortality from sepsis doubles when it is complicated by DIC. The purpose of the study is to evaluate the outcome of ART-123 treatment. Intravenous injection of ART-123 appears to enhance the reversal of DIC and may reduce mortality in subjects with sepsis. It directly inhibits thrombin, (one of the clotting factors) and converts protein C (a protein in the blood that helps breakdown the clots) ART-123 is under investigation and has not yet been approved and registered by the Food and Drug Administration (FDA). ART-123 has been given to more than 700 people in the past in the United States and Japan. These people have been both healthy volunteers as well as critically ill patients.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: ART-123
- Drug: placebo
Phase:
Phase 2/Phase 3Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
Inclusion Criteria:
Infection or suspected infection resulting in sepsis and DIC
Key Exclusion Criteria:
Exclusion Criteria:
Unable to provide informed consent, or lack of consent from an acceptable surrogate
Subjects < 18 years of age
Known conditions that could confound the diagnosis of DIC due to sepsis
Known conditions that increase the risk of bleeding
Known medical condition associated with a hypercoagulable state
Known or suspected severe liver disease
History of solid organ (excluding uncomplicated kidney), bone marrow or stem cell transplantation
Renal failure
Additional Study Details
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Phase-2B Study to Assess the Safety and Efficacy Effects of ART-123 on Subjects With Sepsis and Disseminated Intravascular CoagulationAnticipated start date:
7/1/2007Lead Sponsor:
Artisan Pharma, IncInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- 28-Day All-cause mortality [ Time Frame: 28 day ] [ Designated as safety issue: Yes ]
Total Number to be Enrolled:
750Total Number to be Enrolled at Stanford:
10More Information
Secondary ID(s):
- IRB 9529
- NCT00487656
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
5/14/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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