NCT01857284|CompletedPhase 3DMC

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

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

Beijing Friendship Hospital ClinicalTrials.gov

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1 other identifier

2009L05707

Study Type

interventional

Target

216

Locations

1 country

Sites

Timeline

RegisteredMay 2013

StartedSep 2009

CompletionJan 2013

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

216

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Sep 2009

Typical duration for phase_3

Geographic Reach

1 country

25 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.3 years study duration

Study Start

First participant enrolled

September 1, 2009

Completed

3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed

5 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2013

Completed

4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2013

Completed

Last Updated

May 20, 2013

Status Verified

May 1, 2013

Enrollment Period

3.3 years

First QC Date

May 16, 2013

Last Update Submit

May 16, 2013

Conditions

Primary Biliary Cirrhosis

Keywords

Tauroursodeoxycholic AcidPrimary Biliary CirrhosisSafetyEfficacy

Outcome Measures

Primary Outcomes (1)

The proportion of patients who had AKP decline more than 25% after 24 weeks treatment of UDCA
12 months

Secondary Outcomes (4)

ALP decline from baseline after 24 weeks treatment of TUDCA
12 month
Total bilirubin decline from baseline after 24 weeks treatment of TUDCA
12 months
GGT decline from baseline after 24 weeks treatment of TUDCA
12 months
ALT and AST decline from baseline after 24 weeks treatment of TUDCA
12 months

Study Arms (2)

Group 1

EXPERIMENTAL

Tauroursodeoxycholic Acid Capsules,250mg,tid.

Drug: Tauroursodeoxycholic Acid Capsules

Group 2

ACTIVE COMPARATOR

Ursodeoxycholate acid capsules, 250mg,tid,

Drug: Ursodeoxycholic Acid Capsules

Interventions

Tauroursodeoxycholic Acid CapsulesDRUG

250mg.tid.po

Also known as: Taurolite

Group 1

Ursodeoxycholic Acid CapsulesDRUG

250mg.tid.po

Also known as: Ursofalk

Group 2

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

patients who had been treated with UDCA, immunosuppressive medications within 3 months.
patients who had evidence of extrahepatic biliary obstruction
patients coinfection with HBV or HCV
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.
patients with evidence of decompensated liver disease(ascites, gastrointestinal bleeding, hepatic encephalopathy et al.)
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.
Body Mass Index \>28 kg/m2
drug or alcohol abuse.
patient with severe disease of heart, lung, kidney, alimentary canal, neural system, autoimmune disease or tumor
patient had or on the scheduled of organ transplantation;
patient for whom the follow-up is considered impossible
pregnant or nursing woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Beijing 302 Hospital

Beijing, Beijing Municipality, China

Location

Beijing Ditan Hospital

Beijing, Beijing Municipality, China

Location

Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Location

Beijing Youan Hospital

Beijing, Beijing Municipality, China

Location

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Location

Peiking University First Hosptial

Beijing, Beijing Municipality, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

First Affiliated Hospital,SunYat-Sen University

Guangzhou, Guangdong, China

Location

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Location

Third Affiliated Hospital,SunYat-Sen University

Guangzhou, Guangdong, China

Location

Tongji Hospital

Wuhan, Hunan, China

Location

85 Military Hospital