Non Alcoholic Fatty Liver DiseaseNCT01511523
Study to Evaluate the Effect of RGMA001 on Patients With Non Alcoholic Fatty Liver Disease (NAFLD)
A study testing RGMA001 and Sugar Pill in people with Non Alcoholic Fatty Liver Disease, run by Biovil Research Group, LLC at 1 site in United States.
Trial summary
A research study of a compound containing vitamin E, silymarin and carnitine, three over the counter supplements. The investigators hope to learn if the new supplement can safely and successfully treat fatty liver disease or Non Alcoholic Fatty Liver Disease (NAFLD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Alcoholic Fatty Liver Disease
- What is being tested?
- RGMA001 and Sugar Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Oct 2012
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients age 18 years and older.
- A clinical or histologic or radiographic diagnosis of NAFLD.
- Abnormities above normal range in hepatic function testing consisting of panels containing ALT, AST, AP, Total bilirubin and albumin.
- Negative urine pregnancy test (for females of childbearing potential) collected at screening followed by another negative serum pregnancy test collected within 24 hours prior to the first dose of study drug.
- Female patients of childbearing potential must be on adequate birth control.
- Willingness to give written informed consent and willingness to participate in and comply with the study requirements.
Who cannot join
- History of having received any investigational drug ≤ 3 months prior to the first dose of study drug or the expectation that such drugs will be used during the study. Patients enrolled in this study cannot be enrolled in another study for either research, diagnostic or treatment purposes.
- Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, or anti-HIV Ab.
- History or other evidence of a medical condition associated with chronic liver disease other than NAFLD (e.g., hemochromatosis, viral or autoimmune hepatitis, Wilson's disease, α1-antitrypsin deficiency, alcoholic liver disease, and/or toxin exposure).
- Females who are pregnant or breast feeding.
- Platelet count < 90 x 103 / µL (< 90 x 109 /L) at screening.
- Hemoglobin (Hgb) concentration < 12 g/dL (< 120 g/L) in females or < 13 g/dL (< 30 g/L) in males at screening.
Show all 26Show fewer
- Any patient with a baseline increased risk for anemia (e.g., thalassemia, sickle cell anemia, spherocytosis, history of gastrointestinal bleeding) or for whom anemia would be medically problematic.
- Patients with history of severe psychiatric disease, including psychosis and/or severe depression, characterized by a suicide attempt, hospitalization for psychiatric disease, or a period of disability as a result of psychiatric disease must have a psychiatric evaluation at screening to ensure the patient is now stable and the patient must agree to have continued monitoring by a mental health specialist at least every 4 weeks during the study.
- History of immunologically mediated disease [(e.g., vasculitis, cryoglobulinemia, inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis (defined as affecting > 10% of the body, where the palm of one hand equals 1%, or if the hands and feet are affected), rheumatoid arthritis requiring more than intermittent nonsteroidal anti-inflammatory medications for management, etc.
- Patients with evidence of decompensated liver disease including but not limited to ascites, esophageal varices, and hepatic encephalopathy.
- History of 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 or other evidence of decompensated liver disease or Child-Pugh Grade B or higher [Appendix 1], coagulopathy, hyperbilirubinemia, hepatic encephalopathy, hypoalbuminemia, ascites, and bleeding from esophageal varices are conditions consistent with decompensated liver disease.
- One or more of the following conditions: (1) poorly controlled hypertension, OR (2) screening or baseline blood pressure ≥ 160 mmHg for systolic OR (3) screening or baseline blood pressure ≥ 100 mmHg for diastolic blood pressure.
- History of bleeding disorders or anticoagulant use
- Type I or II diabetes with HbA1C > 8.5% at screening.
- History or other evidence of chronic pulmonary disease associated with functional limitation.
- History of severe cardiac disease (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular disease). Patients with stable coronary artery disease (e.g., 6 months after by-pass surgery, angioplasty with or without stent placement, etc.) as confirmed by a cardiologist will be permitted. In addition, patients with documented or presumed unstable coronary artery disease, stable or unstable cardiovascular disease or cerebrovascular disease, or second or third degree heart block should not be enrolled.
- History of uncontrolled severe seizure disorder.
- Evidence of an active or suspected cancer, or a history of malignancy within the last 2 years, with the exception of patients with basal cell carcinoma that has been excised and cured.
- Poorly controlled thyroid dysfunction.
- History or other evidence of a clinically relevant ophthalmologic disorder due to diabetes mellitus or hypertension or history or other evidence of severe retinopathy (e.g., cytomegalovirus, macular degeneration).
- History of major organ transplantation with an existing functional graft.
- 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.
- Any herbal supplements containing silymarin, tocopherol, vitamin C, bioflavins, curcumin. For complete list see appendix.3
- Consumption of any nutrients know to possess antioxidant activity
- Evidence of excessive alcohol, drug or substance abuse (excluding marijuana use) within 1 year of first dose.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cumberland Research Associates, LLC
Fayetteville, North Carolina, 28304
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of RGMA001 on Patients With Non Alcoholic Fatty Liver Disease (NAFLD).
A research study of a compound containing vitamin E, silymarin and carnitine, three over the counter supplements. The investigators hope to learn if the new supplement can safely and successfully treat fatty liver disease or Non Alcoholic Fatty Liver Disease (NAFLD).
- Conditions
- Non Alcoholic Fatty Liver Disease
- Being tested
- RGMA001, Sugar Pill
- Keywords
- Liver, Fatty, Non Alcoholic, Vitamin E, Silymarin, Carnitine, Supplement, NAFLD
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RGMA001Dietary supplement
3 capsules administered BID once a day.
Sugar PillDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| RGMA001 | Active comparator | Proprietary blend of Vitamin E, Silymarin, and Carnitine. Receives: Dietary Supplement: RGMA001 |
| Sugar Pill | Placebo comparator | No treatment. Receives: Dietary Supplement: Sugar Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Normalization of hepatic AST, ALT, y-GT, albumin, alkaline phosphatase and total bilirubin.
Measured: 30 weeks
Secondary outcomes (1)
Safety
Vital signs, BMI, symptom directed physical exam, pregnancy tests, laboratory tests (hematology, and chemistry), clinical adverse events, dose modifications and treatment discontinuations related to adverse events or laboratory abnormalities.
Measured: 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionOct 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Alcoholic Fatty Liver DiseaseStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biovil Research Group, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Poulos, MD, Principal investigator, Cumberland Research Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511523
- Sponsor's protocol ID
- BVL-001
- Status last verified
- Jan 2012
- First submitted
- 13 Jan 2012
- Last updated
- 16 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of RGMA001 on Patients With Non Alcoholic Fatty Liver Disease (NAFLD).
- ClinicalTrials.gov ID
- NCT01511523
- Acronym / sponsor ID
- BVL-001
- Conditions
- Non Alcoholic Fatty Liver Disease
- Keywords
- Liver, Fatty, Non Alcoholic, Vitamin E, Silymarin, Carnitine, Supplement, NAFLD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Biovil Research Group, LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 18 Jan 2012 (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.
A research study of a compound containing vitamin E, silymarin and carnitine, three over the counter supplements. The investigators hope to learn if the new supplement can safely and successfully treat fatty liver disease or Non Alcoholic Fatty Liver Disease (NAFLD).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RGMA001 | Active comparator | Dietary Supplement: RGMA001Proprietary blend of Vitamin E, Silymarin, and Carnitine. |
| Sugar Pill | Placebo comparator | Dietary Supplement: Sugar PillNo treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female patients age 18 years and older.
- A clinical or histologic or radiographic diagnosis of NAFLD.
- Abnormities above normal range in hepatic function testing consisting of panels containing ALT, AST, AP, Total bilirubin and albumin.
- Negative urine pregnancy test (for females of childbearing potential) collected at screening followed by another negative serum pregnancy test collected within 24 hours prior to the first dose of study drug.
- Female patients of childbearing potential must be on adequate birth control.
Key exclusion criteria (26 listed)
- History of having received any investigational drug ≤ 3 months prior to the first dose of study drug or the expectation that such drugs will be used during the study. Patients enrolled in this study cannot be enrolled in another study for either research, diagnostic or treatment purposes.
- Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, or anti-HIV Ab.
- History or other evidence of a medical condition associated with chronic liver disease other than NAFLD (e.g., hemochromatosis, viral or autoimmune hepatitis, Wilson's disease, α1-antitrypsin deficiency, alcoholic liver disease, and/or toxin exposure).
- Females who are pregnant or breast feeding.
- Platelet count < 90 x 103 / µL (< 90 x 109 /L) at screening.
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 |
|---|---|---|
| RGMA0013 capsules administered BID once a day. | Dietary supplement | RGMA001 |
| Sugar PillPlacebo | Dietary supplement | Sugar Pill |
Primary outcome
Efficacy
Time frame: 30 weeks
Normalization of hepatic AST, ALT, y-GT, albumin, alkaline phosphatase and total bilirubin.
1 secondary outcome
Safety
Time frame: 30 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2012.
Related trials for Non Alcoholic Fatty Liver Disease
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
RecruitingPhase 2
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
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.
John Poulos, MD principal investigator
Cumberland Research Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RGMA001 and Sugar Pill in people with Non Alcoholic Fatty Liver Disease, run by Biovil Research Group, LLC 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 6 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 16 Mar 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
Efficacy (time frame: 30 weeks). 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 16 Mar 2012.