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

NCT00926120 | Completed Phase 2

• 1 other identifier: C.2008.193
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatitis C

Keywords

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (1)

• To assess the efficacy of administering Mogroside sweetener "PureLo" at a dosage level of 5 g every 6 hours over 15 in subjects with chronic hepatitis C (CHC) with respect to the following: hepatitis C viral load; serum ALT levels.

  30 days

Study Arms (1)

Mogroside sweetener

EXPERIMENTAL

All subjects will received Mogroside. Mogroside sweetener administered at a dosage level of 5 g every 6 hours for 14 days.

Dietary Supplement: Mogroside sweetener (PureLo)

Interventions

Mogroside sweetener (PureLo) DIETARY_SUPPLEMENT

Mogroside sweetener administered at a dosage level of 5g every 6 hours for 14 days

Also known as: Pure Lo

Mogroside sweetener

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Brooke Army Medical Center: lead
• The Geneva Foundation: collaborator

Study Sites (1)

Brooke Army Medical Center

San Antonio, Texas, 78234, United States

Location

MeSH Terms

Conditions

Hepatitis C; Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Hepatitis, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen A Harrison, MD

  Brooke Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 22, 2009
• First Posted: June 23, 2009
• Study Start: December 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: January 1, 2010
• Last Updated: February 14, 2012

Record last verified: 2012-02

Locations

US (1)