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Oclassen Clinical Trial R91-001-10 (NIH Protocol 91-DK-AI-213)
Pages 61-65

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From page 61...
... He was one of the first investigators to describe the flare in transaminase levels associated with the successful clearance of HBV from the blood and has established a large group of patients with chronic active HBV whom he follows at the NIH Clinical Center. In conjunction with OcIassen Pharmaceuticals, Hoofnagle and Stephen Straus developed a protocol entitled "A Four Week Course of FlAU for Chronic Hepatitis-B" that was submitted to the NIDDK IRB in August 1991.
From page 62...
... This 59-year-old man with chronic HBV infection died on January 6, 1993, 2 months after laparoscopic cholecystectomy and 4 months after completion of his 28-clay FlAU therapy. He had previously been treated in a 1989 interferon protocol at NTH (a pretreatment liver biopsy in 1989 revealed mild chronic active hepatitis with bridging fibrosis)
From page 63...
... He died of multisystem organ failure and lactic acidosis prior to transplantation. An autopsy performed at NTH revealed inactive cirrhosis of the liver with marked microvesicular steatosis, but rare hepatocyte staining for HBV antigens.
From page 64...
... On the basis of the unchanged liver biopsy findings at the time of the patient's cholecystectomy, the investigators concluded that his subsequent liver failure and death were due to complications of the cholecystectomy, possibly related to the anesthetic agent, rather than to delayed toxicity of FIAU. Since the syndrome of FIAU toxicity was undescribed at the time, the investigators cannot be strongly criticized for coming to this conclusion.
From page 65...
... The attention paid to this patient's death by the investigators and their acute awareness of the peculiar nature of his presentation were no doubt responsible for their increased vigilance throughout the conduct of the ensuing PPPC study and the rapid termination of that trial when a patient presented with a similar syndrome on June 26, 1993.


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