A Pilot Study of the Grapefruit Flavonoid Naringenin for HCV Infection

Completed · Phase 1

Conditions studied: Hepatitis C Virus, HCV Infection, Chronic HCV, Hepatitis C

In brief

Hepatitis C virus when it leaves the cells in the liver is bound to a type of fat. An component of grapefruit could block this fat and thus lower the amount of virus in the blood stream. We propose that treatment with this ingredient, called naringenin, could be used to block this fat and HCV in persons infected with hepatitis C.

Key facts

Study ID

NCT01091077

Run by

Massachusetts General Hospital

People needed

7

Starts

2009-06-01

Expected to finish

2013-08-01

Last updated by the study team

2015-09-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HCV infection as documented by any licensed ELISA test kit any time prior to study entry.
• Documentation of chronic high-titer HCV infection, as defined as a positive HCV viral load >400,000 IU/ML measured within 2 years prior to study entry and after the last interferon-based treatment course.
• HCV genotype - all genotypes are eligible for this trial
• Prior (but not current) treatment with interferon-based therapies are allowed
• Subjects with documented or suspected hepatic cirrhosis must have a Modified Child-Pugh-Turcotte (CPT) Score of 5 or less within 42 days prior to study entry.

You may not qualify if…

• Presence of known causes of significant liver disease including chronic or acute hepatitis B, acute hepatitis A, autoimmune hepatitis, hemochromatosis, or homozygote alpha-1 antitrypsin deficiency.
• Evidence of decompensated liver disease manifested by presence of or history of ascites, variceal bleeding, or hepatic encephalopathy, and/or a Child-Pugh score of 6 or higher.
• History of major organ transplantation, including liver, with an active, functioning graft
• Candidates for liver transplant, as evidenced by active listing
• Receipt of HCV treatment within 28 days prior to study entry.
• Breast-feeding.
• Pregnancy, or considering getting pregnant within 1 month
• Use of lipid-lowering drugs (i.e. HMG-CoA reductase inhibitors, fibrates, omega-3 fatty acids, bile acid sequestrants, ezetimibe, and niacin derivatives), within 3 months prior to study entry
• Use of drugs with known interactions with grapefruit juice
• Known HIV infection
• Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
• History of an adverse reaction to citrus fruits
• History of uncontrolled seizure disorder.
• Uncontrolled depression or other psychiatric disorder such as untreated Grade 3 psychiatric disorder, Grade 3 disorder not amenable to medical intervention, or any hospitalization within the past 52 weeks that in the opinion of the site investigator might preclude tolerability of study requirements.
• History of autoimmune processes, including but not limited to Crohn's disease, ulcerative colitis, severe psoriasis, rheumatoid arthritis, that have been exacerbated by previous interferon use.
• Any systemic antineoplastic or immunomodulatory treatment or radiation within 24 weeks prior to study entry.
• Serious illness including malignancy, active symptomatic coronary artery disease within 24 weeks prior to study entry, or other chronic medical conditions that may preclude completion of the protocol in the investigator's opinion.
• Past history of estrogen-responsive breast cancer
• Use of antidiabetic medications within 12 weeks prior to study entry.
• Fasting plasma glucose ≥126 mg/dL within 42 days prior to study entry or currently or previously treated at any time for diabetes with measures other than diet. NOTE: Women with a history of gestational diabetes not requiring any treatment for diabetes before or after pregnancy are eligible for participation. Subjects with diabetes/hyperglycemia occurring in the context of short-term use of corticosteroids, growth hormone, or other diabetogenic medication, but not requiring any treatment for diabetes after discontinuation of the implicated medication, are eligible to participate. Subjects with diabetes/hyperglycemia following an episode of pancreatitis who no longer require treatment for diabetes are eligible.
• Known osteoporosis or receipt of treatment of osteopenia or osteoporosis within 12 weeks prior to study entry with the following medications: risedronate (Actonel®), ibandronate (Boniva®), etidronate (Didronel®), raloxifene (Evista®), teriparatide (Forteo®), aledronate (Fosamax®), calcitonin (Miacalcin®).
• Inability to tolerate consumption of an ice cream-based milkshake.
• Regular and excessive use of alcohol defined as self-reported alcohol intake >120 g of alcohol/week in a male or >60 g alcohol/week in a female within 12 weeks immediately prior to study entry.
• Unwilling to restrict alcohol use during the study to ≤120g alcohol/week in a male or ≤60 g alcohol/week in a female.
• Unwilling to restrict diet during the study (both Step 1 and Step 2).

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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