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

Primary Biliary Cirrhosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01857284
• Other study ID #: 2009L05707
• Status: Completed
• Phase: Phase 3
• First received: May 16, 2013
• Last updated: May 16, 2013
• Start date: September 2009
• Est. completion date: January 2013

Study information

• Verified date: May 2013
• Source: Beijing Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Cirrhosis
• Liver Cirrhosis, Biliary
• Primary Biliary Cirrhosis

Intervention

Drug:
• Tauroursodeoxycholic Acid Capsules
250mg.tid.po
• Ursodeoxycholic Acid Capsules
250mg.tid.po

Locations

Country	Name	City	State
China	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	West China Hospital	Chengdu	Sichuan
China	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	The Sixth People's Hospital of Hangzhou	Hangzhou	Zhejiang
China	First Affiliated Hospital Of KunMing Medical College	Kunming	Yunnan
China	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	Tongji Hospital	Wuhan	Hunan
China	Xijing Hospital	Xian	Shanxi
China	First Affiliated Hospital of Zhejiang University	Zhejiang	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Friendship Hospital	Beijing Trendful Kangjian Medical Information Consulting Limited Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients who had AKP decline more than 25% after 24 weeks treatment of UDCA		12 months	No
Secondary	ALP decline from baseline after 24 weeks treatment of TUDCA		12 month	No
Secondary	Total bilirubin decline from baseline after 24 weeks treatment of TUDCA		12 months	No
Secondary	GGT decline from baseline after 24 weeks treatment of TUDCA		12 months	No
Secondary	ALT and AST decline from baseline after 24 weeks treatment of TUDCA		12 months	No