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Trial record 8 of 85 for:    "Primary biliary cirrhosis"

Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary Cirrhosis

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ClinicalTrials.gov Identifier: NCT01857284
Recruitment Status : Completed
First Posted : May 20, 2013
Last Update Posted : May 20, 2013
Sponsor:
Collaborator:
Beijing Trendful Kangjian Medical Information Consulting Limited Company
Information provided by (Responsible Party):
Jia Ji-Dong, Beijing Friendship Hospital

Brief Summary:
Though ursodeoxycholate acid (UDCA) is the wellknown effective therapy for PBC, clinical effectiveness of UDCA may be limited by its poor absorption and extensive biotransformation. The more hydrophilic bile acid tauroursodeoxycholate (TUDCA) is the active ingredients of UDCA, and has been approved by state food and drug administration in China for treatment of cholesterol stones. So it is necessary to verify the efficacy and safety of TUDCA in the treatment of adult primary biliary cirrhosis. In this randomized, double-blinded, double-dummy, parallel-controlled and multicenter clinical trial, we detect the proportion of patients who had AKP decline more than 25% as the primary outcome; decline of AKP, total bilirubin, GGT, ALT and AST as secondary outcomes after patients were treated with TUDCA or UDCA for 24 weeks.

Condition or disease Intervention/treatment Phase
Primary Biliary Cirrhosis Drug: Tauroursodeoxycholic Acid Capsules Drug: Ursodeoxycholic Acid Capsules Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical Trial to Investigate Safety and Efficacy of Tauroursodeoxycholic Acid Capsules in Treatment of Adult Primary Biliary Cirrhosis
Study Start Date : September 2009
Primary Completion Date : January 2013
Study Completion Date : January 2013


Arm Intervention/treatment
Experimental: Group 1
Tauroursodeoxycholic Acid Capsules,250mg,tid.
Drug: Tauroursodeoxycholic Acid Capsules
250mg.tid.po
Other Name: Taurolite
Active Comparator: Group 2
Ursodeoxycholate acid capsules, 250mg,tid,
Drug: Ursodeoxycholic Acid Capsules
250mg.tid.po
Other Name: Ursofalk



Primary Outcome Measures :
  1. The proportion of patients who had AKP decline more than 25% after 24 weeks treatment of UDCA [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. ALP decline from baseline after 24 weeks treatment of TUDCA [ Time Frame: 12 month ]
  2. Total bilirubin decline from baseline after 24 weeks treatment of TUDCA [ Time Frame: 12 months ]
  3. GGT decline from baseline after 24 weeks treatment of TUDCA [ Time Frame: 12 months ]
  4. ALT and AST decline from baseline after 24 weeks treatment of TUDCA [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • written informed consent
  • aged 18-70 years
  • increase in alkaline phosphatase for 2 folds or more
  • positive anti-mitochondrial antibody (AMA) with presence of antibodies against the pyruvate dehydrogenase complex (AMA-M2);AMA-negative patients should be diagnosed as PBC with histologic evidence.

Exclusion Criteria:

  1. patients who had been treated with UDCA, immunosuppressive medications within 3 months.
  2. patients who had evidence of extrahepatic biliary obstruction
  3. patients coinfection with HBV or HCV
  4. patients with one of the followings: 1) hemoglobin(HB): <11 g/dl in male, <10 g/dl in female 2) white blood cell count <3000/mm3 3) neutrophile granulocyte <1500/mm3 4) platelet <50000/mm3; 5) serum albumin <3.3 g/dl 6) alanine aminotransferase(ALT)≥10×ULN and/or aspartate aminotransferase(ALT)≥10×ULN; 7) ALT≥5×ULN and/or AST≥5×ULN coexisting with immunoglobulin G (IgG) ≥2×ULN; 8) total bilirubin ≥4×ULN; 9) prothrombin time (PT) prolong 3 seconds or more, or PTA ≦60%; 10) creatinine ≥4×ULN.
  5. patients with evidence of decompensated liver disease(ascites, gastrointestinal bleeding, hepatic encephalopathy et al.)
  6. definitely diagnosed as hepatocellular carcinoma(HCC), probable HCC, AFP>100ng/ml.Patients with AFP>2×ULN while <100ng/ml should re-test 2 weeks later.
  7. Body Mass Index >28 kg/m2
  8. drug or alcohol abuse.
  9. patient with severe disease of heart, lung, kidney, alimentary canal, neural system, autoimmune disease or tumor
  10. patient had or on the scheduled of organ transplantation;
  11. patient for whom the follow-up is considered impossible
  12. pregnant or nursing woman

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01857284


Locations
China, Beijing
Beijing 302 Hospital
Beijing, Beijing, China
Beijing Ditan Hospital
Beijing, Beijing, China
Beijing Friendship Hospital
Beijing, Beijing, China
Beijing Youan Hospital
Beijing, Beijing, China
Chinese PLA General Hospital
Beijing, Beijing, China
Peiking University First Hosptial
Beijing, Beijing, China
Peking University People's Hospital
Beijing, Beijing, China
China, Guangdong
First Affiliated Hospital,SunYat-Sen University
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Third Affiliated Hospital,SunYat-Sen University
Guangzhou, Guangdong, China
China, Hunan
Tongji Hospital
Wuhan, Hunan, China
China, Shanghai
85 Military Hospital
Shanghai, Shanghai, China
Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai, China
Huashan Hospital
Shanghai, Shanghai, China
NO.3 People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai, China
RenJi Hospital
Shanghai, Shanghai, China
RuiJin Hospital
Shanghai, Shanghai, China
ShangHai Changzheng Hospital
Shanghai, Shanghai, China
Shanghai Public Health Clinical Center
Shanghai, Shanghai, China
Shanghai Zhongshan Hospital
Shanghai, Shanghai, China
China, Shanxi
Xijing Hospital
Xian, Shanxi, China
China, Sichuan
West China Hospital
Chengdu, Sichuan, China
China, Yunnan
First Affiliated Hospital Of KunMing Medical College
Kunming, Yunnan, China
China, Zhejiang
The Sixth People's Hospital of Hangzhou
Hangzhou, Zhejiang, China
First Affiliated Hospital of Zhejiang University
Zhejiang, Zhejiang, China
Sponsors and Collaborators
Beijing Friendship Hospital
Beijing Trendful Kangjian Medical Information Consulting Limited Company
Investigators
Principal Investigator: Dong Ji Jia, Doctor Beijing Friendship Hospital

Responsible Party: Jia Ji-Dong, Professor, Beijing Friendship Hospital
ClinicalTrials.gov Identifier: NCT01857284     History of Changes
Other Study ID Numbers: 2009L05707
First Posted: May 20, 2013    Key Record Dates
Last Update Posted: May 20, 2013
Last Verified: May 2013

Keywords provided by Jia Ji-Dong, Beijing Friendship Hospital:
Tauroursodeoxycholic Acid
Primary Biliary Cirrhosis
Safety
Efficacy

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Liver Cirrhosis, Biliary
Pathologic Processes
Liver Diseases
Digestive System Diseases
Cholestasis, Intrahepatic
Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Ursodeoxycholic Acid
Tauroursodeoxycholic acid
Taurochenodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents
Antiviral Agents
Anti-Infective Agents