Primary Biliary CirrhosisPhase 3NCT01857284
Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary Cirrhosis
A Phase 3 study testing Tauroursodeoxycholic Acid Capsules and Ursodeoxycholic Acid Capsules in people with Primary Biliary Cirrhosis, run by Beijing Friendship Hospital at 25 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary Biliary Cirrhosis
- What is being tested?
- Tauroursodeoxycholic Acid Capsules and Ursodeoxycholic Acid Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 25 sitesChina
- Study dates
- Sep 2009to Jan 2013
- 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
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
China25 sites
Beijing 302 Hospital
Beijing, Beijing Municipality
Beijing Ditan Hospital
Beijing, Beijing Municipality
Beijing Friendship Hospital
Beijing, Beijing Municipality
Beijing Youan Hospital
Beijing, Beijing Municipality
Chinese PLA General Hospital
Beijing, Beijing Municipality
Peiking University First Hosptial
Beijing, Beijing Municipality
Peking University People's Hospital
Beijing, Beijing Municipality
West China Hospital
Chengdu, Sichuan
First Affiliated Hospital,SunYat-Sen University
Guangzhou, Guangdong
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong
Third Affiliated Hospital,SunYat-Sen University
Guangzhou, Guangdong
The Sixth People's Hospital of Hangzhou
Hangzhou, Zhejiang
First Affiliated Hospital Of KunMing Medical College
Kunming, Yunnan
85 Military Hospital
Shanghai, Shanghai Municipality
Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai Municipality
Huashan Hospital
Shanghai, Shanghai Municipality
NO.3 People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
RenJi Hospital
Shanghai, Shanghai Municipality
RuiJin Hospital
Shanghai, Shanghai Municipality
ShangHai Changzheng Hospital
Shanghai, Shanghai Municipality
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality
Tongji Hospital
Wuhan, Hunan
Xijing Hospital
Xian, Shanxi
First Affiliated Hospital of Zhejiang University
Zhejiang, Zhejiang
About this study
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
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.
- Conditions
- Primary Biliary Cirrhosis
- Being tested
- Tauroursodeoxycholic Acid Capsules, Ursodeoxycholic Acid Capsules
- Keywords
- Tauroursodeoxycholic Acid, Primary Biliary Cirrhosis, Safety, Efficacy
- Medical subject headings
- Liver Cirrhosis, Biliary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tauroursodeoxycholic Acid CapsulesDrug
Also called Taurolite
250mg.tid.po
Ursodeoxycholic Acid CapsulesDrug
Also called Ursofalk
250mg.tid.po
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Tauroursodeoxycholic Acid Capsules,250mg,tid. Receives: Drug: Tauroursodeoxycholic Acid Capsules |
| Group 2 | Active comparator | Ursodeoxycholate acid capsules, 250mg,tid, Receives: Drug: Ursodeoxycholic Acid Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who had AKP decline more than 25% after 24 weeks treatment of UDCA
Measured: 12 months
Secondary outcomes (4)
ALP decline from baseline after 24 weeks treatment of TUDCA
Measured: 12 month
Total bilirubin decline from baseline after 24 weeks treatment of TUDCA
Measured: 12 months
GGT decline from baseline after 24 weeks treatment of TUDCA
Measured: 12 months
ALT and AST decline from baseline after 24 weeks treatment of TUDCA
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startSep 2009
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Biliary CirrhosisStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- 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
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Trendful Kangjian Medical Information Consulting Limited Company
- Responsible party
- Principal investigator, Jia Ji-Dong, Beijing Friendship Hospital
- Investigators
- Dong Ji Jia, Doctor, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857284
- Sponsor's protocol ID
- 2009L05707
- Status last verified
- May 2013
- First submitted
- 16 May 2013
- Last updated
- 20 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01857284
- Acronym / sponsor ID
- 2009L05707
- Conditions
- Primary Biliary Cirrhosis
- Keywords
- Tauroursodeoxycholic Acid, Primary Biliary Cirrhosis, Safety, Efficacy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Collaborators
- Beijing Trendful Kangjian Medical Information Consulting Limited Company
- Study start
- Sep 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 20 May 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Tauroursodeoxycholic Acid CapsulesTauroursodeoxycholic Acid Capsules,250mg,tid. |
| Group 2 | Active comparator | Drug: Ursodeoxycholic Acid CapsulesUrsodeoxycholate acid capsules, 250mg,tid, |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.)
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 |
|---|---|---|
| Tauroursodeoxycholic Acid CapsulesAlso: Taurolite250mg.tid.po | Drug | Group 1 |
| Ursodeoxycholic Acid CapsulesAlso: Ursofalk250mg.tid.po | Drug | Group 2 |
Primary outcome
The proportion of patients who had AKP decline more than 25% after 24 weeks treatment of UDCA
Time frame: 12 months
4 secondary outcomes
ALP decline from baseline after 24 weeks treatment of TUDCA
Time frame: 12 month
Total bilirubin decline from baseline after 24 weeks treatment of TUDCA
Time frame: 12 months
GGT decline from baseline after 24 weeks treatment of TUDCA
Time frame: 12 months
ALT and AST decline from baseline after 24 weeks treatment of TUDCA
Time frame: 12 months
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 20 May 2013.
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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.
Dong Ji Jia, Doctor principal investigator
Beijing Friendship Hospital
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tauroursodeoxycholic Acid Capsules and Ursodeoxycholic Acid Capsules in people with Primary Biliary Cirrhosis, run by Beijing Friendship Hospital at 25 sites in China.
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 4 inclusion and 12 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 20 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites 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?
The proportion of patients who had AKP decline more than 25% after 24 weeks treatment of UDCA (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2013.