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Clinical Studies

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  • A Multicenter, Randomized, Double Blinded, Placebo-controlled Clinical Trial of Anakinra (Plus Zinc), or Prednisone in Patients With Severe Alcoholic Hepatitis by the AlcHepNet Consortium (AlcHepNet02) Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz. Severe AH continues to be associated with a high mortality and represents a significant public health burden. Prednisone is the standard of care but is associated with a modest and transient survival benefit at best and increased risk of severe bacterial and fungal infections. A recent large study indicated that pentoxifylline is not significantly superior to placebo. While several new targets are being evaluated, they are not sufficiently powered to provide definitive data.
  • An Open-Label, Cohort Dose Escalation Study to Assess the Safety and Efficacy of F-652 in Patients With Alcoholic Hepatitis (TREAT 008) Jacksonville, Fla., Rochester, Minn., Mankato, Minn., Scottsdale/Phoenix, Ariz.

    Alcoholic hepatitis is a syndrome of progressive inflammatory liver injury associated with long-term heavy intake of ethanol. The pathogenesis is not completely understood. Patients who are severely affected present with subacute onset of fever, hepatomegaly, leukocytosis, marked impairment of liver function (e.g., jaundice, coagulopathy), and manifestations of portal hypertension (e.g., ascites, hepatic encephalopathy, variceal hemorrhage). However, milder forms of alcoholic hepatitis often do not cause any symptoms. Alcoholic hepatitis usually persists and progresses to cirrhosis if heavy alcohol use continues. If alcohol use ceases, alcoholic hepatitis resolves slowly over weeks to months, sometimes without permanent sequelae but often with residual cirrhosis. F-652 is a recombinant fusion protein containing human interleukin 22 (IL-22) and human Immunoglobulin G2 (IgG2)-Fc produced in CHO cells in serum-free culture. F-652 under development is intended to treat patients with graft vs host disease (GvHD) after bone marrow transplantation, and acute alcoholic hepatitis (AAH), a severe form of alcoholic liver disease (ALD). Both GvHD and AAH are diseases with unmet medical need. The current investigational new drug (IND) application is to conduct a phase Ia clinical study in GvHD patients to evaluate the safety and pharmacokinetic profile, and biomarkers of F-652 treatment by intravenous infusion (IV). IL-22 is a member of the IL-10 family of cytokines which control bacterial infection, homeostasis, and tissue repair. IL-22 may be used to treat patients with ALD because of its antioxidant, anti-apoptotic, anti-steatotic, anti-microbial, and proliferative effect that have been demonstrated in various experimental systems.

  • AURORA: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- Controlled Study to Evaluate the Efficacy and Safety of Cenicriviroc for Treatment of Liver Fibrosis in Adult Subjects with Nonalcoholic Steatohepatitis Jacksonville, Fla.

    The AURORA study will be conducted to confirm the efficacy and safety of cenicriviroc (CVC) for the treatment of liver fibrosis in adult subjects with NASH.

  • Exercise Intervention and Its Impact on Hospitalization - a Mulitcentered Study Jacksonville, Fla., Rochester, Minn., Scottsdale/Phoenix, Ariz.

    Skeletal muscle abnormalities (sarcopenia) and frailty are common complications seen in patients with end-stage liver disease. The presence of these complications portends poor prognosis. The purpose of this study is to assess the impact of a formal home based video strengthening program (REST) on sarcopenia and frailty. We also want to assess the impact of this exercise program on complication rates, hospitalization, on quality of life (QOL) and on survival.