Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:48 AM
Study NCT ID:
NCT06174402
Status:
RECRUITING
Last Update Posted:
2025-08-05
First Post:
2023-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis
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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 184}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-03', 'studyFirstSubmitDate': '2023-12-08', 'studyFirstSubmitQcDate': '2023-12-08', 'lastUpdatePostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients with biochemical response', 'timeFrame': '48 weeks', 'description': 'The normalisation of Alkaline Phosphatase'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients having biochemical response', 'timeFrame': '4, 12, 24 and 36weeks', 'description': 'The normalisation of Alkaline Phosphatase at 4, 12, 24, and 36 weeks'}, {'measure': 'Assessment of the pruritus', 'timeFrame': '4, 12, 24, 36, and 48 weeks', 'description': 'Change From Baseline in Pruritus as Assessed by Visual Analogue Scale (VAS) Total Score for Fatigue and Pruritus. (0-10, higher scores mean a worse outcome)'}, {'measure': 'Assessment of the fatigue', 'timeFrame': '4, 12, 24, 36, and 48 weeks', 'description': 'Change From Baseline in Fatigue as Assessed by Visual Analogue Scale (VAS) Total Score for Fatigue and Pruritus. (0-10, higher scores mean a worse outcome)'}, {'measure': 'Percentage of patients having biological or clinical adverse events', 'timeFrame': '4, 12, 24, 36, and 48 weeks', 'description': 'Increase of creatinine, blood urea nitrogen, alanine aminotransferase and aspartate aminotransferase'}, {'measure': 'Survival without transplantation and hepatic impairment', 'timeFrame': '48 weeks', 'description': 'Occurrence of ascites, variceal bleeding, hepatic encephalopathy, liver-transplantation, or death'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Biliary Cholangitis']}, 'descriptionModule': {'briefSummary': 'The main objectives of the study were to assess the effects of fenofibrate on serum alkaline phosphatase, as a composite endpoint and on safety in participants with primary biliary cholangitis (PBC)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have provided written informed consent\n* Age 18-75 years;\n* BMI 17-28 kg/m2\n* Male or female with a diagnosis of PBC, by at least two of the following criteria:\n\n 1. History of alkaline phosphatase（ALP） above upper limit of normal（ULN） for at least six months;\n 2. Positive Anti-mitochondrial antibody (AMA) titers (\\>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies;\n 3. Documented liver biopsy result consistent with PBC.\n* Incomplete response to UDCA defined by 1 x ULN\\< ALP \\<= 1.67 x ULN\n* Taking UDCA for at least 6 months (stable dose for ≥ 3 months) prior to Day 0\n\nExclusion Criteria:\n\n* History or presence of other concomitant liver diseases.\n* ALT or AST \\> 5×ULN, total bilirubin（TBIL） \\> 3×ULN.\n* If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating.\n* Allergic to fenofibrate or ursodeoxycholic acid.\n* Taking hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months, and long-term hormonal users.\n\nRecurrent variceal bleeding, poorly controlled hepatic encephalopathy or refractory ascites.\n\n* Patients with a history of severe cardiac, cerebrovascular, renal, respiratory disease or functional failure, and psychiatric disorders (including those due to alcohol and drug abuse).\n* Creatinine \\>1.5×ULN and creatinine clearance \\<60 ml/min.\n* Currently using statins (such as pravastatin, fluvastatin, and simvastatin), other fibrates (such as gemfibrozil and bezafibrate), and drugs structurally similar to fenofibrate (like ketoprofen).\n* Planned to receive an organ transplant or an organ transplant recipient.\n* Needing Liver transplantation within 1 year according to the Mayo Rick score.\n* Any other condition(s) that would compromise the safety of the subject or compromise'}, 'identificationModule': {'nctId': 'NCT06174402', 'briefTitle': 'Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital of Digestive Diseases'}, 'officialTitle': 'Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis', 'orgStudyIdInfo': {'id': 'KY-20232219-C-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fenofibrate-ursodesoxycholic acid（UDCA）', 'description': 'Fenofibrate 200 mg/day and UDCA 13-15mg/kg/day for 12 months', 'interventionNames': ['Drug: Fenofibrate', 'Drug: UDCA']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo-UDCA', 'description': '1 tablet/ day and UDCA 13-15mg/kg/day for 12 months', 'interventionNames': ['Drug: Placebo', 'Drug: UDCA']}], 'interventions': [{'name': 'Fenofibrate', 'type': 'DRUG', 'description': 'Fenofibrate 200 mg/day', 'armGroupLabels': ['Fenofibrate-ursodesoxycholic acid（UDCA）']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '1 tablet/ day', 'armGroupLabels': ['Placebo-UDCA']}, {'name': 'UDCA', 'type': 'DRUG', 'description': 'UDCA 13-15mg/kg/day', 'armGroupLabels': ['Fenofibrate-ursodesoxycholic acid（UDCA）', 'Placebo-UDCA']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lanzhou', 'state': 'Gansu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhang', 'role': 'CONTACT', 'email': 'zhanglymd@126.com', 'phone': '15193100697'}], 'facility': 'The second hospital of Lanzhou University', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhuang', 'role': 'CONTACT', 'email': 'zhuangyy5@mail.sysu.edu.cn', 'phone': '13632322509'}], 'facility': 'Sun Yat-sen Memorial Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li', 'role': 'CONTACT', 'email': 'dr-lijun@vip.sina.com', 'phone': '13905175333'}], 'facility': 'Jiangsu Province Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li', 'role': 'CONTACT', 'email': 'lijier@nju.edu.cn', 'phone': '15863787910'}], 'facility': 'Nanjing Drum Tower Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yang', 'role': 'CONTACT', 'email': 'lijier@nju.edu.cn', 'phone': '13951990210'}], 'facility': 'Nanjing Second Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dou', 'role': 'CONTACT', 'email': 'guang40@163.com', 'phone': '18940251121'}], 'facility': 'Shengjing Hospital Affiliated to China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ying Han', 'role': 'CONTACT', 'email': 'hanying1@fmmu.edu.cn', 'phone': '+862984771539'}, {'name': 'Ying Han', 'role': 'CONTACT'}], 'facility': 'Xijing Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': 'Yan’an', 'state': 'Shanxxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Gao', 'role': 'CONTACT', 'email': '13891118887@163.com', 'phone': '13891118887'}], 'facility': "Yan'an University Affiliated Hospital", 'geoPoint': {'lat': 36.59889, 'lon': 109.49167}}, {'city': 'Kunming', 'state': 'Yunnan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tang', 'role': 'CONTACT', 'email': 'tangyingmei_med@163.com', 'phone': '15308845032'}], 'facility': 'The Second Affiliated Hospital of Kunming Medical University', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fei', 'role': 'CONTACT', 'email': 'feiyunyun@pumch.cn', 'phone': '13681125226'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Han Ying', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Han Ying', 'investigatorAffiliation': 'Xijing Hospital of Digestive Diseases'}}}}