Study With Heptral in Subjects With Liver Disease Due to Alcohol Consumption
Overview[ - collapse ][ - ]
| Purpose | A research study of an approved drug called Heptral®, ademetionine, to treat adults with intrahepatic cholestasis (a condition where bile cannot flow from the liver to the duodenum) in pre-cirrhotic and cirrhotic states. Experience from clinical studies in subjects with liver disease has shown that ademetionine is effective. |
|---|---|
| Condition | Intrahepatic Cholestasis Associated With Alcoholic Liver Disease |
| Intervention | Drug: Ademetionine IV+tablet Drug: Ademetionine tablet |
| Phase | Phase 3 |
| Sponsor | Abbott |
| Responsible Party | Abbott |
| ClinicalTrials.gov Identifier | NCT02200029 |
| First Received | July 21, 2014 |
| Last Updated | August 13, 2014 |
| Last verified | July 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | July 21, 2014 |
|---|---|
| Last Updated Date | August 13, 2014 |
| Start Date | August 2014 |
| Estimated Primary Completion Date | December 2014 |
| Current Primary Outcome Measures | Concentrations (Units per liter) of Alkaline phosphatase (ALP) or gamma-glutamyltransferase (γGT) [Time Frame: from baseline up to the end of treatment visit (56-60 days)] [Designated as safety issue: No]Improvement of ALP or γGT after 8 weeks of treatment with ademetionine compared to baseline |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Study With Heptral in Subjects With Liver Disease Due to Alcohol Consumption |
|---|---|
| Official Title | Open-Label Study With Ademetionine (Heptral®) in Subjects With Intrahepatic Cholestasis (IHC) Associated With Alcoholic Liver Disease (ALD) |
| Brief Summary | A research study of an approved drug called Heptral®, ademetionine, to treat adults with intrahepatic cholestasis (a condition where bile cannot flow from the liver to the duodenum) in pre-cirrhotic and cirrhotic states. Experience from clinical studies in subjects with liver disease has shown that ademetionine is effective. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Intrahepatic Cholestasis Associated With Alcoholic Liver Disease |
| Intervention | Drug: Ademetionine IV+tablet IV ademetionine (500 mg/vial) for 2 weeks followed by oral ademetionine (500 mg/tablet, 2 in the morning and 1 before dinner) for 6 weeks Drug: Ademetionine tablet oral ademetionine (500 mg/tablet, 2 in the morning and 1 before dinner) for 8 weeks |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 50 |
| Estimated Completion Date | December 2014 |
| Estimated Primary Completion Date | December 2014 |
| Eligibility Criteria | Inclusion criteria: - Signed informed consent given by the subject - Age ≥ 18 years to 75 years - Chronic liver disease due to alcoholic liver disease - Compensated alcoholic liver disease, defined as having a Maddrey Score < 32 and not being treated with pentoxifylline or prednisolone within 6 months prior to the study - History of chronic alcohol use, defined as, history of consumption of > 40 g of alcohol per day for females and > 80 g alcohol per day for males for more than 5 years prior to enrolment - Subjects who abstain from alcohol for more than 2 weeks and will not consume alcohol during the study - Subjects with Intrahepatic Cholestasis (IHC): - ALP: more than 1.5 x upper normal limit and - γGT: more than 3 x upper normal limit - Subjects with additional serum conjugated bilirubin (SCB) > Upper Limit of Normal (ULN) will be selected for initial IV treatment Exclusion Criteria: - Subjects with a known hypersensitivity to the active substance of ademetionine or to any of the inactive ingredients - Subjects with extrahepatic cause of cholestasis (proven by ultrasound or described in medical history) - Diagnosis of human immunodeficiency virus (HIV) in medical history - Subjects with chronic liver disease Child-Pugh class C - Subjects in the decompensation stage of ALD (such as Maddrey Score >32) - Subjects with primary sclerosing cholangitis (PSC) - Subjects with primary biliary cirrhosis (PBC) - Any form of malignancy within the past 5 years and/or basal cell carcinoma and squamous cell carcinoma of the skin within the past two years - Subjects with drug-induced liver disease - History of active substance abuse (oral, inhaled or injected) within one year prior to the study - Subjects with renal impairment (creatinine level of >2.0 mg/dL or > 150 µmol/l) - Subjects with known genetic defects affecting the methionine cycle and/or causing homocystinuria and/or hyperhomocysteinemia (e.g., cystathionine beta-synthase deficiency, Vitamin B12 metabolism defect) or known folate, Vitamin B6 or B12 deficiency - Subjects on total parenteral nutrition in the year prior to screening - Subjects after or planned for bariatric surgery (jejunoileal bypass or gastric weight loss surgery) - Subjects after liver transplantation and subjects on the waiting list for liver transplantation - Subjects with any of the following disease in medical history: - Viral hepatitis (serum positive HBcAb or Hepatitis C Virus (HCV) RNA) - Evidence of autoimmune liver disease - Wilson´s disease - Hemochromatosis - Alpha-1-antitrypsin deficiency - Subjects with history of biliary diversion - History of major depression or bipolar disease - Women of childbearing potential: positive urine pregnancy test during screening or unwillingness to use an effective form of birth control during the study. - Breastfeeding women - Any condition that, in the opinion of the investigator, does not justify the patient's inclusion into the study - Investigational drug intake within one month prior to the study - Active, serious medical disease other than ALD with likely life-expectancy less than five years |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: van Assche +31 (0)294 477367 hanneke.vanassche@abbott.com |
| Location Countries | Russian Federation |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT02200029 |
|---|---|
| Other Study ID Numbers | M14-168 |
| Has Data Monitoring Committee | No |
| Information Provided By | Abbott |
| Study Sponsor | Abbott |
| Collaborators | Ascent Datamap ClinIntel Catalent |
| Investigators | Study Director: Suntje Sander-Struckmeier, PhD Abbott |
| Verification Date | July 2014 |
Locations[ + expand ][ + ]
| Research facility ORG-000957 | Moscow, Russian Federation, 117292 Recruiting |
|---|---|
| Research facility ORG-000963 | Moscow, Russian Federation, 129110 Not yet recruiting |
| Research facility ID ORG-000726 | Moscow, Russian Federation, 125284 Not yet recruiting |
| Research facility ID ORG-000959 | Moscow, Russian Federation, 111539 Withdrawn |
| Research facility ID ORG-000960 | Moscow, Russian Federation, 119992 Not yet recruiting |
| Research facility ORG-000961 | Moscow, Russian Federation, 119435 Not yet recruiting |
| Research facility ORG-000962 | Moscow, Russian Federation, 107014 Recruiting |
| Research facility ORG-000964 | Moscow, Russian Federation, 129128 Not yet recruiting |
| Research facility ORG-000970 | St. Petersburg, Russian Federation, 198216 Not yet recruiting |
| Research facility ORG-000965 | St. Petersburg, Russian Federation, 197022 Not yet recruiting |
| Research facility ORG-000966 | St. Petersburg, Russian Federation, 191015 Not yet recruiting |
| Research facility ORG-000967 | St. Petersburg, Russian Federation, 117630 Not yet recruiting |
| Research facility ORG-000968 | St. Petersburg, Russian Federation, 195257 Not yet recruiting |
| Research facility ORG-000958 | Troitsk, Russian Federation, 142190 Recruiting |
| Research facility ORG-000969 | Yaroslavl, Russian Federation, 150003 Not yet recruiting |