Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary Cirrhosis (no)

This study has been completed.
Sponsor:
Collaborator:
Beijing Trendful Kangjian Medical Information Consulting Limited Company
Information provided by (Responsible Party):
Jia Ji-Dong, Beijing Friendship Hospital
ClinicalTrials.gov Identifier:
NCT01857284
First received: May 16, 2013
Last updated: NA
Last verified: May 2013
History: No changes posted
  Purpose

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 Intervention Phase
Primary Biliary Cirrhosis
Drug: Tauroursodeoxycholic Acid Capsules
Drug: Ursodeoxycholic Acid Capsules
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Beijing Friendship Hospital:

Primary Outcome Measures:
  • The proportion of patients who had AKP decline more than 25% after 24 weeks treatment of UDCA [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ALP decline from baseline after 24 weeks treatment of TUDCA [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • Total bilirubin decline from baseline after 24 weeks treatment of TUDCA [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • GGT decline from baseline after 24 weeks treatment of TUDCA [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • ALT and AST decline from baseline after 24 weeks treatment of TUDCA [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 216
Study Start Date: September 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01857284

Locations
China, Beijing
Chinese PLA General Hospital
Beijing, Beijing, China
Beijing Ditan Hospital
Beijing, Beijing, China
Beijing Youan Hospital
Beijing, Beijing, China
Peking University People's Hospital
Beijing, Beijing, China
Peiking University First Hosptial
Beijing, Beijing, China
Beijing 302 Hospital
Beijing, Beijing, China
Beijing Friendship Hospital
Beijing, Beijing, China
China, Guangdong
First Affiliated Hospital,SunYat-Sen University
Guangzhou, Guangdong, China
Third Affiliated Hospital,SunYat-Sen University
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
China, Hunan
Tongji Hospital
Wuhan, Hunan, China
China, Shanghai
Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai, China
RuiJin Hospital
Shanghai, Shanghai, China
ShangHai Changzheng Hospital
Shanghai, Shanghai, China
Shanghai Public Health Clinical Center
Shanghai, Shanghai, China
NO.3 People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai, China
Huashan Hospital
Shanghai, Shanghai, China
Shanghai Zhongshan Hospital
Shanghai, Shanghai, China
RenJi Hospital
Shanghai, Shanghai, China
85 Military 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
  More Information

No publications provided

Responsible Party: Jia Ji-Dong, Professor, Beijing Friendship Hospital
ClinicalTrials.gov Identifier: NCT01857284     History of Changes
Other Study ID Numbers: 2009L05707
Study First Received: May 16, 2013
Last Updated: May 16, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Beijing Friendship Hospital:
Tauroursodeoxycholic Acid
Primary Biliary Cirrhosis
Safety
Efficacy

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

ClinicalTrials.gov processed this record on October 19, 2014