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

Hepatitis C Clinical Trial

Official title: A Phase II, Open-label, Efficacy and Safety Study to Evaluate the Effects of Mogroside Sweetener "PureLo" on Viral Load in Treatment Naïve, Genotype 1 Subjects With Chronic Hepatitis C

Status Completed

Clinical Trial 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.

Clinical Trial Description

The primary objectives of the study are to assess the safety and efficacy of administering Mogroside Sweetener "PureLo" to genotype 1 subjects at a dose level of 5 grams every 6 hours for 14 days on hepatitis C viral load and serum ALT levels. Percentage change in HCV load over the first 48 hours and daily for 14 days and change in serum ALT levels over the two week period of study, will be calculated for each patient. The number of subjects who show a decline in viral load of at least 50% will then be calculated, as will the number of subjects who decrease their serum ALT levels by at least 50%. All efficacy and safety analysis will be conducted at the end of the study. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C

• NCT number: NCT00926120
• Study type: Interventional
• Source: Brooke Army Medical Center
• Status: Completed
• Phase: Phase 2
• Start date: December 2008
• Completion date: January 2010