The Effects of Mogroside Sweetener on Viral Load in TreatmenT Naive Genotype 1 (GT 1) Subjects CHC

Completed · Phase 2

Conditions studied: Hepatitis C

In brief

The purpose of this study is to determine if administering Mogroside Sweetener "PureLo" (the study substance) for 14 days will lower the hepatitis C viral load and liver function alanine aminotransferase (ALT) levels.

Key facts

Study ID

NCT00926120

Run by

Brooke Army Medical Center

People needed

10

Starts

2008-12-01

Expected to finish

2010-01-01

Last updated by the study team

2012-02-14

Who can join

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

You may qualify if…

• Serologic evidence of HVC infection by an anti-HCV antibody test.
• Serum HCV RNA quantifiable > 20,000 copies/mL at screening period and demonstrate abnormal ALT > 40 for 6 months.
• No clinical suspicion or radiological evidence of hepatocellular carcinoma and a serum AFP < 50 ng/mL.
• Negative urine pregnancy test for women of childbearing potential documented within the 24-hour period prior to the first dose for test drug.

You may not qualify if…

• Interferon with or without RBV therapy at any previous time or any other systemic antiviral therapy or investigational drug > 3 months prior to the first dose of study drug.
• Subjects who are expected to need systemic antiviral therapy at any time during the study are also excluded.
• Positive test at screening for anti-HAV 1gM Ab, HbsAg, anti-HBc IgM Ab, or anti-HIV Ab.
• Documented serum concentrations of ceruloplasmin or Alpha 1-antitrypsin consistent with an increased risk of metabolic liver disease.
• History or other evidence of a medical condition associated with chronic liver disease (e.g., haemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures).
• Women with ongoing pregnancy or breast feeding
• Neutrophil count < 1000 cells/mm3, Hgb <11 g/dL in women or 12 g/dL in men, or platelet count < 80,000 cells/mm3.
• Serum creatinine level > 2 times the upper limit of normal at screening.
• Evidence of alcohol and/or drug abuse within one year of entry.
• History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquillizer at therapeutic doses for major depression or psychosis, respectively, for at least 4 months at any previous time or any history of the following:
• a suicidal attempt
• hospitalization for psychiatric disease, OR
• a period of disability due to a psychiatric disease.
• History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematous, autoimmune hemolytic anemia, scleroderma, severe psoriasis, sarcoidosis, etc.).
• History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease including ascites or hepatic encephalopathy.
• History or other evidence of chronic pulmonary disease associated with functional limitation.
• History of severe cardiac disease.
• History of a severe seizure disorder or current anticonvulsant use.
• Evidence of an active or suspected cancer or a past history of malignancy other than skin cancer.
• History of having received any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) ≤ 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study.
• History of major organ transplantation with an existing functional graft.
• History of thyroid disease poorly controlled on prescribed medications.
• History or other evidence of severe retinopathy.
• Inability or unwillingness to provide informed consent or abide by the requirements of the study.
• History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study.

Where it is running

• Brooke Army Medical Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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