Cholestatic Liver DiseasePhase 3NCT01829698

Efficacy and Safety Study of TUDCA Compare UDCA to Treatment Chronic Cholestatic Liver Disease-PBC

A Phase 3 study testing tauroursodeoxycholic and ursodeoxycholic acid in people with Cholestatic Liver Disease, run by Beijing Trendful Kangjian Medical Information Consulting Limited Company at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Cholestatic Liver Disease
What is being tested?: tauroursodeoxycholic and ursodeoxycholic acid
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 199 participants
Where: 1 siteChina
Study dates: Aug 2009to Feb 2014
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1 Ages Eligible for Study: 18 Years to 70 Years
2 Alkaline phosphatase (ALP) ≥ 2 times the Upper Limits of Normal (ULN);
3 Anti mitochondrial antibody (AMA) positive and / or anti-mitochondrial antibody subtype M2 (AMA-M2) positive; if the AMA and AMA-M2 were negative, need liver biopsy confirmed pathological changes in PBC.

Who cannot join

1．in the 3 months before screening received UDCA, hormones, immunosuppressive therapy;
2．with extrahepatic biliary obstruction;
3．accompanied by hepatitis B virus (HBV) and hepatitis C virus (HCV) infection;
4．laboratory screening examination :
hemoglobin (HB): male< 11 g/dL, female <10 g/dL < g/dL;
the total white blood cell (WBC) count < 3000/mm3;

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the absolute neutrophil count (ANC) <1500/mm3;
platelet (PLT) count <50000/mm3;
serum albumin <3.3g/dL;
alanine aminotransferase (ALT) ≥ 10 ULN and / or aspartate aminotransferase (AST) ≥ 10ULN;
ALT ≥ 5 ULN and / or AST ≥ 5 ULN with immunoglobulin G (IgG) ≥ 2ULN;
total bilirubin (T-Bil) ≥ 4 ULN;
prothrombin time (PT) prolonged ≥ 3 seconds (limit reference value based on) or PTA ≤ 60%;
the serum creatinine (Cr) ≥ 1.5ULN.
5．patients with esophageal variceal or bleeding, ascites, hepatic encephalopathy or other evidence of hepatic decompensation;
6．diagnosed with liver cancer, suspected to have liver cancer, AFP > 100ng/ml. As the AFP in 2 times the upper limit of normal to 100ng/ml, need re-check in 2 weeks, if their AFP > 100ng/ml can not be included
7．body mass index >28 (Kg/m2);
8．alcohol or drug abusers within the recent year;
9．there is a serious heart, lung, kidney, digestive, nervous, mental disease, autoimmune diseases or malignant tumor
10．drug-induced liver injury;
11. plan to transplant or have had organ transplants;
12． are unable or unwilling to provide informed consent or fails to comply with the test requirements;
13．pregnant, lactating women.

Trial locations and contacts

1 site in 1 country.

China1 site

Liver Research Center,Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050

Other trials in China

About this study

Official title: Evaluate the Efficacy And Safety Of TUDCA Compare UDCA In The Treatment Of Cholestatic Liver Disease-PBC by A Randomized,Double-Blind,Double Dummy,Parallel-Controlled,Multicenter Trial and The Consecutive Treatment By TUDCA

Though ursodeoxycholate acid (UDCA) is the well known effective therapy for PBC,clinical effectiveness of UDCA may be limited by its poor absorption and extensive biotransformation.The more hydrophillic 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 ALP,total bilirubin, GGT,ALT and AST as secondary outcomes after patients were treated with TUDCA or UDCA for 24 weeks.

Read the detailed description

This is a double-blind, randomized, parallel controlled, multicenter, clinical trial. Subjects inclusion by randomization after passing the screening, continuous administration the test drug (Taurolite) or control drug (Ursofalk) treatment for 24 weeks. Compare the safety and efficacy of Taurolite vs Ursofalk.

At the end of the double-blind period，enroll 100 subjects from both two group randomly ,for a consecutive treatment use TUDCA up to 24 weeks. Further evaluate the efficacy and safety of tauroursodeoxycholic acid (TUDCA) in the treatment of adult primary biliary cirrhosis (PBC) for a long time up to one year. Also evaluate the regimen's efficacy and safety that udca take placed by TUDCA in the treatment of adult primary biliary cirrhosis (PBC) for the patients who use udca treatment for 24 weeks.

Conditions: Cholestatic Liver Disease
Being tested: tauroursodeoxycholic, ursodeoxycholic acid
Keywords: tudca PBC Cholestasis tauroursodeoxycholic acid taurolite

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

tauroursodeoxycholicDrug
Also called TUDCA, Taurolite
Testing arm: tauroursodeoxycholic acid, 750mg , divided into three times, each time 250mg, oral administration, after meal
ursodeoxycholic acidDrug
Also called UDCA, Ursofalk
ursodeoxycholic acid, 750mg ,divided into three times, each time 250mg, oral administration, after meal

Study groups in NCT01829698
Study group	Role	What they receive
tauroursodeoxycholic	Experimental	tauroursodeoxycholic acid, 750mg , divided into three times, each time 250mg, oral administration, after meal Receives: Drug: tauroursodeoxycholic
ursodeoxycholic	Active comparator	control arm: ursodeoxycholic acid, 750mg ,divided into three times, each time 250mg, oral administration, after meal Receives: Drug: ursodeoxycholic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

Efficiency is defined as the patients composition whose ALP level of serum decreased more than 25% compared to baseline at treatment for 24 weeks.
After 24 weeks of treatment, calculate the rate of patients whose ALP level of serum ALP decreased more than 25% compared to the baseline. After 48 weeks of treatment, calculate the rate of patients whose ALP level of serum ALP decreased more than 40% compared to the baseline.
Measured: 48 weeks

Secondary outcomes (1)

The change of laboratory parameters about liver function
1. after 24 weeks of treatment, the serum level ALP decreased compared with baseline.
2. after 24 weeks of treatment, the serum bilirubin level decreased compared with baseline.
3. after 24 weeks of treatment, the serum level of GGT decreased compared with baseline.
4. after 24 weeks of treatment, serum ALT, AST levels decreased compared to baseline.
5. after 48 weeks of treatment, the serum level ALP decreased compared with 24 weeks.
6. after 48 weeks of treatment, the serum level ALP decreased compared with baseline.
7. after 48 weeks of treatment, the serum bilirubin level decreased compared with 24 weeks.
8. after 48 weeks of treatment, the serum level of GGT decreased compared with 24 weeks.
9. after 48 weeks of treatment, serum ALT, AST levels decreased compared to 24 weeks.
Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2009Feb 2014

First posted11 Apr 2013 (estimated)
Study startAug 2009
Primary completionJan 2013
Study completionFeb 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cholestatic Liver DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 199 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01829698
Sponsor's protocol ID: Trendful-TAU-001
Other IDs: 2009L05707
Status last verified: Mar 2014
First submitted: 9 Apr 2013
Last updated: 24 Mar 2014
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND)
Cholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC)
Not yet recruitingPhase 2
Nemolizumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus
Chronic Hepatic Pruritus, Cholestatic Liver Disease
RecruitingPhase 1
Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease
Hepatic Impairment, Cirrhosis
RecruitingPhase 1
Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease
Cholestatic Liver Disease
RecruitingPhase 4
Vitamin D2 vs Vitamin D2 Plus Calcitriol in Cholestatic Children With Vitamin D Deficiency
Cholestatic Liver Disease, Chronic Liver Disease (CLD)

All Cholestatic Liver Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluate the Efficacy And Safety Of TUDCA Compare UDCA In The Treatment Of Cholestatic Liver Disease-PBC by A Randomized,Double-Blind,Double Dummy,Parallel-Controlled,Multicenter Trial and The Consecutive Treatment By TUDCA
ClinicalTrials.gov ID: NCT01829698
Acronym / sponsor ID: Trendful-TAU-001
Conditions: Cholestatic Liver Disease
Keywords: tudca PBC Cholestasis tauroursodeoxycholic acid taurolite
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 199 participants (actual)
Lead sponsor: Beijing Trendful Kangjian Medical Information Consulting Limited CompanyUniversity, hospital or other
Study start: Aug 2009
Primary completion: Jan 2013 (actual)
Study completion: Feb 2014 (actual)
First posted: 11 Apr 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
tauroursodeoxycholic	Experimental	Drug: tauroursodeoxycholictauroursodeoxycholic acid, 750mg , divided into three times, each time 250mg, oral administration, after meal
ursodeoxycholic	Active comparator	Drug: ursodeoxycholic acidcontrol arm: ursodeoxycholic acid, 750mg ,divided into three times, each time 250mg, oral administration, after meal

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

1 Ages Eligible for Study: 18 Years to 70 Years
2 Alkaline phosphatase (ALP) ≥ 2 times the Upper Limits of Normal (ULN);
3 Anti mitochondrial antibody (AMA) positive and / or anti-mitochondrial antibody subtype M2 (AMA-M2) positive; if the AMA and AMA-M2 were negative, need liver biopsy confirmed pathological changes in PBC.

Key exclusion criteria (23 listed)

1．in the 3 months before screening received UDCA, hormones, immunosuppressive therapy;
2．with extrahepatic biliary obstruction;
3．accompanied by hepatitis B virus (HBV) and hepatitis C virus (HCV) infection;
5．patients with esophageal variceal or bleeding, ascites, hepatic encephalopathy or other evidence of hepatic decompensation;
6．diagnosed with liver cancer, suspected to have liver cancer, AFP > 100ng/ml. As the AFP in 2 times the upper limit of normal to 100ng/ml, need re-check in 2 weeks, if their AFP > 100ng/ml can not be included

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
tauroursodeoxycholicAlso: TUDCA, TauroliteTesting arm: tauroursodeoxycholic acid, 750mg , divided into three times, each time 250mg, oral administration, after meal	Drug	tauroursodeoxycholic
ursodeoxycholic acidAlso: UDCA, Ursofalkursodeoxycholic acid, 750mg ,divided into three times, each time 250mg, oral administration, after meal	Drug	ursodeoxycholic

Primary outcome

Efficiency is defined as the patients composition whose ALP level of serum decreased more than 25% compared to baseline at treatment for 24 weeks.
Time frame: 48 weeks
After 24 weeks of treatment, calculate the rate of patients whose ALP level of serum ALP decreased more than 25% compared to the baseline. After 48 weeks of treatment, calculate the rate of patients whose ALP level of serum ALP decreased more than 40% compared to the baseline.

1 secondary outcome

The change of laboratory parameters about liver function
Time frame: 48 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2014.

Related trials for Cholestatic Liver Disease

Active, not recruitingPhase 3
Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND)
Cholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC)
Not yet recruitingPhase 2
Nemolizumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus
Chronic Hepatic Pruritus, Cholestatic Liver Disease
RecruitingPhase 1
Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease
Hepatic Impairment, Cirrhosis
RecruitingPhase 1
Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease
Cholestatic Liver Disease
RecruitingPhase 4
Vitamin D2 vs Vitamin D2 Plus Calcitriol in Cholestatic Children With Vitamin D Deficiency
Cholestatic Liver Disease, Chronic Liver Disease (CLD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ji Dong Jia, Doctor principal investigator

Beijing Friendship Hospital

Wen Xie, Doctor study director

Beijing Ditan Hospital

Hui Ping Yan, Doctor study director

Beijing YouAn Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficiency is defined as the patients composition whose ALP level of serum decreased more than 25% compared to baseline at treatment for 24 weeks. (time frame: 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01829698.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2014; AzTrials last refreshed its copy on 26 Oct 2026.