Hepatitis CPhase 2PureLoNCT00926120
The Effects of Mogroside Sweetener on Viral Load in TreatmenT Naive Genotype 1 (GT 1) Subjects CHC
A Phase 2 study testing Mogroside sweetener (PureLo) in people with Hepatitis C, run by Brooke Army Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Mogroside sweetener (PureLo)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Jan 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brooke Army Medical Center
San Antonio, Texas, 78234
About this study
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
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.
Read the 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.
- Conditions
- Hepatitis C
- Being tested
- Mogroside sweetener (PureLo)
- Keywords
- Chronic Hepatitis C
- Medical subject headings
- Hepatitis C, Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mogroside sweetener (PureLo)Dietary supplement
Also called Pure Lo
Mogroside sweetener administered at a dosage level of 5g every 6 hours for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Mogroside sweetener | Experimental | All subjects will received Mogroside. Mogroside sweetener administered at a dosage level of 5 g every 6 hours for 14 days. Receives: Dietary Supplement: Mogroside sweetener (PureLo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2009 (estimated)
- Study startDec 2008
- Primary completionApr 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- The Geneva Foundation
- Responsible party
- Principal investigator, Stephen A Harrison, Brooke Army Medical Center
- Investigators
- Stephen A Harrison, MD, Principal investigator, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926120
- Sponsor's protocol ID
- C.2008.193
- Acronym
- PureLo
- Status last verified
- Feb 2012
- First submitted
- 22 Jun 2009
- Last updated
- 14 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00926120
- Acronym / sponsor ID
- PureLo / C.2008.193
- Conditions
- Hepatitis C
- Keywords
- Chronic Hepatitis C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Collaborators
- The Geneva Foundation
- Study start
- Dec 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 23 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mogroside sweetener | Experimental | Dietary Supplement: Mogroside sweetener (PureLo)All subjects will received Mogroside. Mogroside sweetener administered at a dosage level of 5 g every 6 hours for 14 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (25 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mogroside sweetener (PureLo)Also: Pure LoMogroside sweetener administered at a dosage level of 5g every 6 hours for 14 days | Dietary supplement | Mogroside sweetener |
Primary outcome
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.
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen A Harrison, MD principal investigator
Brooke Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mogroside sweetener (PureLo) in people with Hepatitis C, run by Brooke Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2012.