Study to Evaluate the Effect of RGMA001 on Patients With Non Alcoholic Fatty Liver Disease (NAFLD)

NCT01511523 | Unknown

• 1 other identifier: BVL-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Non Alcoholic Fatty Liver Disease

Keywords

Liver; Fatty; Non Alcoholic; Vitamin E; Silymarin; Carnitine; Supplement; NAFLD

Outcome Measures

Primary Outcomes (1)

• Efficacy

  Normalization of hepatic AST, ALT, y-GT, albumin, alkaline phosphatase and total bilirubin.

  30 weeks

Secondary Outcomes (1)

• Safety

  30 weeks

Study Arms (2)

RGMA001

ACTIVE COMPARATOR

Proprietary blend of Vitamin E, Silymarin, and Carnitine.

Dietary Supplement: RGMA001

Sugar Pill

PLACEBO COMPARATOR

No treatment.

Dietary Supplement: Sugar Pill

Interventions

RGMA001 DIETARY_SUPPLEMENT

3 capsules administered BID once a day.

RGMA001

Sugar Pill DIETARY_SUPPLEMENT

Placebo

Sugar Pill

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Biovil Research Group, LLC: lead

Study Sites (1)

Cumberland Research Associates, LLC

Fayetteville, North Carolina, 28304, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Sugars

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• John Poulos, MD

  Cumberland Research Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2012
• First Posted: January 18, 2012
• Study Start: January 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: March 16, 2012

Record last verified: 2012-01

Locations

US (1)