Arbios Systems, Inc., announced that the Company has received conditional approval from the U.S. Food and Drug Administration (FDA) of an Investigational Device Exemption to begin the pivotal clinical trial for SEPET™, Arbios’ extracorporeal artificial liver assist device for blood purification of chronically ill patients suffering from acute liver failure. Permission was granted to initiate the trial while the Company responds to the FDA’s conditions and request for additional information. In particular, FDA has requested a survival primary endpoint, which could potentially increase the total number of patients required for the trial. The trial design proposed by the Company has a primary endpoint of a two-stage drop in hepatic encephalopathy and its secondary endpoints include several survival based endpoints.
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February 23, 2008
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Good post!!! Thanks....
Posted by: International Regulatory Affairs | May 14, 2009 at 15:03
Great post!!! Thanks.....
Posted by: Clinical Trial Regulations | May 16, 2009 at 13:44