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Pravastatin Intervention in HCC

Condition: Hepatocellular carcinoma

Eligibility

Key Inclusion Criteria

  • At least 18 years old
  • Diagnosis of liver cirrhosis
  • Diagnosis of hepatocellular carcinoma

Key Exclusion Criteria

  • Current use of statin medication or statin use within 12 months of screening visit
  • Current use of medications known to interact with statins and potentially increase toxicity
  • History of adverse effects, intolerance, or allergic reactions attributed to other statin medications
Please see complete list of inclusion and exclusion criteria

Full Study Name

Pravastatin Intervention to Delay Hepatocellular Carcinoma Recurrence (IRB no. 48985)

Summary

This study focuses on individuals who have been diagnosed with an early-stage hepatocellular carcinoma (HCC) and who have been treated with therapies targeting the liver. The purpose of the study is to examine the effects that an investigational drug called pravastatin has on the time it takes for HCC to occur again in patients with early-stage HCC. Researchers believe that pravastatin, in combination with therapies targeting the liver, may delay or protect against HCC occurring again.

Pravastatin is a type of statin that is approved by the U.S. Food and Drug Administration (FDA) for various conditions. However, it is not approved by the FDA to delay or protect against HCC occurring again. The study will compare the effects of pravastatin against the effects of a placebo (inactive substance). Participants will be randomly assigned to receive either pravastatin or a placebo.

Phase

Phase II

Principal Investigator

Shehnaz Hussain, PhD

Clinical Investigators

Walid S. Ayoub, MD (Principal)
Vinay Sundaram, MD
Mazen Noureddin, MD

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