Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT00926120
Status:
COMPLETED
Last Update Posted:
2012-02-14
First Post:
2009-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Mogroside Sweetener on Viral Load in TreatmenT Naive Genotype 1 (GT 1) Subjects CHC
Sponsor:
Brooke Army Medical Center
Organization:
Study Overview
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
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PureLo
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.
Detailed 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: