{ "FullStudy":{ "Rank":218193, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01511523", "OrgStudyIdInfo":{ "OrgStudyId":"BVL-001" }, "Organization":{ "OrgFullName":"Biovil Research Group, LLC", "OrgClass":"INDUSTRY" }, "BriefTitle":"Study to Evaluate the Effect of RGMA001 on Patients With Non Alcoholic Fatty Liver Disease (NAFLD)", "OfficialTitle":"A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of RGMA001 on Patients With Non Alcoholic Fatty Liver Disease (NAFLD)." }, "StatusModule":{ "StatusVerifiedDate":"January 2012", "OverallStatus":"Unknown status", "LastKnownStatus":"Enrolling by invitation", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"October 2012", "PrimaryCompletionDateType":"Anticipated" }, "CompletionDateStruct":{ "CompletionDate":"October 2012", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 13, 2012", "StudyFirstSubmitQCDate":"January 17, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 18, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"March 15, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"March 16, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Biovil Research Group, LLC", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"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)." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Non Alcoholic Fatty Liver Disease" ] }, "KeywordList":{ "Keyword":[ "Liver", "Fatty", "Non Alcoholic", "Vitamin E", "Silymarin", "Carnitine", "Supplement", "NAFLD" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Supportive Care", "DesignMaskingInfo":{ "DesignMasking":"Triple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"40", "EnrollmentType":"Anticipated" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"RGMA001", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Proprietary blend of Vitamin E, Silymarin, and Carnitine.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Dietary Supplement: RGMA001" ] } },{ "ArmGroupLabel":"Sugar Pill", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"No treatment.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Dietary Supplement: Sugar Pill" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Dietary Supplement", "InterventionName":"RGMA001", "InterventionDescription":"3 capsules administered BID once a day.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "RGMA001" ] } },{ "InterventionType":"Dietary Supplement", "InterventionName":"Sugar Pill", "InterventionDescription":"Placebo", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Sugar Pill" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Efficacy", "PrimaryOutcomeDescription":"Normalization of hepatic AST, ALT, y-GT, albumin, alkaline phosphatase and total bilirubin.", "PrimaryOutcomeTimeFrame":"30 weeks" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Safety", "SecondaryOutcomeDescription":"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.", "SecondaryOutcomeTimeFrame":"30 weeks" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nMale and female patients age 18 years and older.\nA clinical or histologic or radiographic diagnosis of NAFLD.\nAbnormities above normal range in hepatic function testing consisting of panels containing ALT, AST, AP, Total bilirubin and albumin.\nNegative 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.\nFemale patients of childbearing potential must be on adequate birth control.\nWillingness to give written informed consent and willingness to participate in and comply with the study requirements.\n\nExclusion Criteria:\n\nHistory 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.\nPositive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, or anti-HIV Ab.\nHistory 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).\nFemales who are pregnant or breast feeding.\nPlatelet count < 90 x 103 / µL (< 90 x 109 /L) at screening.\nHemoglobin (Hgb) concentration < 12 g/dL (< 120 g/L) in females or < 13 g/dL (< 30 g/L) in males at screening.\nAny 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.\nPatients 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.\nHistory 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.\nPatients with evidence of decompensated liver disease including but not limited to ascites, esophageal varices, and hepatic encephalopathy.\nHistory 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\nHistory 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.\nOne 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.\nHistory of bleeding disorders or anticoagulant use\nType I or II diabetes with HbA1C > 8.5% at screening.\nHistory or other evidence of chronic pulmonary disease associated with functional limitation.\nHistory 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.\nHistory of uncontrolled severe seizure disorder.\nEvidence 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.\nPoorly controlled thyroid dysfunction.\nHistory 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).\nHistory of major organ transplantation with an existing functional graft.\nHistory 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.\nAny herbal supplements containing silymarin, tocopherol, vitamin C, bioflavins, curcumin. For complete list see appendix.3\nConsumption of any nutrients know to possess antioxidant activity\nEvidence of excessive alcohol, drug or substance abuse (excluding marijuana use) within 1 year of first dose.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"John Poulos, MD", "OverallOfficialAffiliation":"Cumberland Research Associates", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Cumberland Research Associates, LLC", "LocationCity":"Fayetteville", "LocationState":"North Carolina", "LocationZip":"28304", "LocationCountry":"United States" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000008107", "ConditionMeshTerm":"Liver Diseases" },{ "ConditionMeshId":"D000005234", "ConditionMeshTerm":"Fatty Liver" },{ "ConditionMeshId":"D000065626", "ConditionMeshTerm":"Non-alcoholic Fatty Liver Disease" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000004066", "ConditionAncestorTerm":"Digestive System Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M9690", "ConditionBrowseLeafName":"Liver Diseases", "ConditionBrowseLeafAsFound":"Liver Disease", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M6958", "ConditionBrowseLeafName":"Fatty Liver", "ConditionBrowseLeafAsFound":"Fatty Liver", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M29127", "ConditionBrowseLeafName":"Non-alcoholic Fatty Liver Disease", "ConditionBrowseLeafAsFound":"Non-alcoholic Fatty Liver Disease", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M7466", "ConditionBrowseLeafName":"Gastrointestinal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5838", "ConditionBrowseLeafName":"Digestive System Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T5891", "ConditionBrowseLeafName":"Visceral Steatosis", "ConditionBrowseLeafAsFound":"Fatty Liver", "ConditionBrowseLeafRelevance":"high" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC06", "ConditionBrowseBranchName":"Digestive System Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"Rare", "ConditionBrowseBranchName":"Rare Diseases" } ] } } } } } }