Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-01-17 @ 11:15 PM
Study NCT ID:
NCT02823366
Status:
UNKNOWN
Last Update Posted:
2022-09-30
First Post:
2016-01-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008105', 'term': 'Liver Cirrhosis, Biliary'}], 'ancestors': [{'id': 'D002780', 'term': 'Cholestasis, Intrahepatic'}, {'id': 'D002779', 'term': 'Cholestasis'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011345', 'term': 'Fenofibrate'}], 'ancestors': [{'id': 'D058607', 'term': 'Fibric Acids'}, {'id': 'D058610', 'term': 'Isobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D001577', 'term': 'Benzophenones'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D007659', 'term': 'Ketones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 104}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-27', 'studyFirstSubmitDate': '2016-01-28', 'studyFirstSubmitQcDate': '2016-06-30', 'lastUpdatePostDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in symptom-pruritus.', 'timeFrame': 'Week 24', 'description': 'The symptom of pruritus will be evaluated by questionnaire before enrolment and at the end of the study.'}, {'measure': 'Change in symptom-fatigue.', 'timeFrame': 'Week 24', 'description': 'The symptom of fatigue will be evaluated by Fatigue Impact Scale before enrolment and at the end of the study.'}, {'measure': 'Change in serum Immunoglobulin M Levels.', 'timeFrame': 'Week 24', 'description': 'Absolute change in serum levels of Immunoglobulin M compared to the baseline.'}], 'primaryOutcomes': [{'measure': 'Rate of patients with complete biochemical response', 'timeFrame': 'Week 24', 'description': 'Normalization of alkaline phosphatase (ALP) or decrease of ALP by more than 40% compared to the baseline.'}], 'secondaryOutcomes': [{'measure': 'Change in liver biopsy examinations according to conventional Ludwig system.', 'timeFrame': 'Week 48', 'description': 'Histological evolution will be checked by liver biopsy at the end of the study to compare with baseline histological status. The Ludwig histological classification schemes will be used, which categorised the disease into four stages.'}, {'measure': 'Change in GLOBE risk scores after treatment.', 'timeFrame': 'Week 48', 'description': 'The prognostic scores will be calculated at entry and end of study by GLOBE scoring system, which calculated based on serum values of bilirubin, ALP, albumin and platelet count after 1 year of treatment and age at baseline.'}, {'measure': 'Change in liver stiffness status measured by magnetic resonance elastography.', 'timeFrame': 'Week 48', 'description': 'The change of liver stiffness status at the end of the study compared to baseline checked by magnetic resonance elastography.'}, {'measure': 'Change in serum levels of ALP compared to the baseline.', 'timeFrame': 'Weeks 0, 4, 8, 12, 24, and 48', 'description': 'Absolute change in serum levels of ALP compared to the baseline.'}, {'measure': 'Change in serum levels of bilirubin compared to the baseline.', 'timeFrame': 'Weeks 0, 4, 8, 12, 24, and 48', 'description': 'Absolute change in serum levels of bilirubin compared to the baseline.'}, {'measure': 'Change in serum levels of transaminase compared to the baseline.', 'timeFrame': 'Weeks 0, 4, 8, 12, 24, and 48', 'description': 'Absolute change in serum levels of transaminase compared to the baseline.'}]}, 'conditionsModule': {'keywords': ['PBC', 'UDCA', 'Fenofibrate'], 'conditions': ['Primary Biliary Cirrhosis']}, 'descriptionModule': {'briefSummary': 'Ursodeoxycholic acid (UDCA) has been the only treatment for PBC approved by US and European drug administrations. Long-term use of UDCA(13-15 mg/kg/day) in patients with PBC improves serum liver biochemistries and survival free of liver transplantation However, about 40% of patients do not respond to UDCA optimally as assessed by known criteria for biochemical response. Those patients represent the group in need for additional therapies, having increased risk of disease progression and decreased survival free of liver transplantation. Both lab research and some clinical studies suggest that fenofibrate could improve cholestasis in multiple ways including reduce of bile acid synthesis, increase of biliary secretion and anti-inflammation effect. Here we start a random, open and parallel clinical research to explore the effect of fenofibrate in the PBC treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Signed informed consent\n2. Patient with PBC defined by 2 in 3 of the following criteria: a.Positive antimitochondrial antibody type M2; b.Abnormal serum alkaline phosphatases (ALP \\> 1,5N) and aminotransferase (AST or ALT \\> 1N) activities; c.Histological hepatic injuries consistent with PBC.\n3. Had been treated with UDCA more than 6 months, and failed to achieve a complete biochemical response.\n\nExclusion Criteria:\n\n1. Pregnancy or desire of pregnancy.\n2. Breast-feeding.\n3. Co-existing liver diseases such as acute or chronic viral hepatitis, alcoholic liver disease, choledocholithiasis, autoimmune hepatitis, biopsy-proven non-alcoholic fatty liver disease, Wilson's disease and hemochromatosis.\n4. History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy, or poorly controlled ascites).\n5. History of urolithiasis, nephritis or renal failure (clearance of creatinine \\< 60 ml/mn).\n6. Hepatotoxic drugs use before recruiting.\n7. Fenofibrate anaphylaxis."}, 'identificationModule': {'nctId': 'NCT02823366', 'briefTitle': 'Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital of Digestive Diseases'}, 'orgStudyIdInfo': {'id': 'KY20151230-5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fenofibrate + UDCA', 'description': 'Fenofibrate in combination with ursodeoxycholic acid', 'interventionNames': ['Drug: Fenofibrate', 'Drug: UDCA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Monotherapy', 'description': 'UDCA alone', 'interventionNames': ['Drug: UDCA']}], 'interventions': [{'name': 'Fenofibrate', 'type': 'DRUG', 'armGroupLabels': ['Fenofibrate + UDCA']}, {'name': 'UDCA', 'type': 'DRUG', 'armGroupLabels': ['Fenofibrate + UDCA', 'Monotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ying Han, Ph.D', 'role': 'CONTACT', 'email': 'hanying@fmmu.edu.cn', 'phone': '86-29-84771539'}, {'name': 'Yongquan Shi, Ph.D', 'role': 'CONTACT', 'email': 'shiyquan@fmmu.edu.cn', 'phone': '86-29-84771515'}], 'facility': 'Xijing Hosipital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Ying Han, Ph.D', 'role': 'CONTACT', 'email': 'hanying@fmmu.edu.cn', 'phone': '86-29-84771539'}, {'name': 'Yongquan Shi, Ph.D', 'role': 'CONTACT', 'email': 'shiyquan@fmmu.edu.cn', 'phone': '86-29-84771515'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital of Digestive Diseases', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Consultant Physician', 'investigatorFullName': 'Han Ying', 'investigatorAffiliation': 'Xijing Hospital of Digestive Diseases'}}}}