Chronic Hepatitis CPhase 3NCT00200343
Efficacy and Safety Study of Ursodeoxycholic Acid to Treat Chronic Hepatitis C
A Phase 3 study testing Ursodeoxycholic acid 150mg / day, Ursodeoxycholic acid 600mg / day and Ursodeoxycholic acid 900mg / day in people with Chronic Hepatitis C, run by Tanabe Pharma Corporation at 1 site in Japan.
Trial summary
This study is a 24-week multicenter, randomized, double-blind control trial with ursodeoxycholic acid (UDCA) in patients with chronic hepatitis C in Japan. The primary objectives of this study are to verify the superiority of efficacy of UDCA 600 or 900mg/day to that of 150mg/day and the safety of UDCA treatment. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- Ursodeoxycholic acid 150mg / day, Ursodeoxycholic acid 600mg / day and Ursodeoxycholic acid 900mg / day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 596 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2002to Dec 2004
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must have a clinical diagnosis to apply the conservative medication for chronic hepatitis C.
- Serum alanine aminotransferase levels measured at 4-week before the initiation of treatment must be over 61 IU/mL.
- Subject's age must be 20 years or older.
Who cannot join
- Subject who received a treatment of antiviral agents (interferon) within 20 weeks before the start of 8-week observation period
- Subject who received a treatment of corticosteroids, immunosuppressive drugs, glycyrrhizic acid, cholestyramine or other drugs which could interfere with hepatic function during 8-week observation period.
- Subject with decompensated cirrhosis
- Subject infecting with other hepatic virus
- Subject receiving a treatment for autoimmune disease, alcohol or drug-induced hepatic disorder, neoplasia, hepato-cholangiolar disease, fulminant hepatitis or peptic ulcer
- Subject who require hospitalization for complications of the heart, kidney or pancreas
Show all 11Show fewer
- Pregnancy
- Alcoholics
- Alcohol intake more than 27 ml/day
- Subject who involved in other clinical trial within 4 weeks before the start of observation period
- Subject with a history of sensitivity to ursodeoxycholic acid or bile acid-products
Trial locations and contacts
1 site in 1 country.
Japan1 site
Department of Gastroenterology, University of Tokyo
Hongo, Bunkyo-ku, Tokyo
About this study
Official title: A 24-week Multicenter Double-blind Control Trial With Ursodeoxycholic Acid in Patients With Chronic Hepatitis C
This study is a 24-week multicenter, randomized, double-blind control trial with ursodeoxycholic acid (UDCA) in patients with chronic hepatitis C in Japan. The primary objectives of this study are to verify the superiority of efficacy of UDCA 600 or 900mg/day to that of 150mg/day and the safety of UDCA treatment.
Read the detailed description
This study is a 24-week multicenter, randomized, double-blind control trial with ursodeoxycholic acid (UDCA) in patients with chronic hepatitis C in Japan. The primary objectives of this study are to verify the superiority of efficacy of UDCA 600 or 900mg/day to that of 150mg/day and the safety of UDCA treatment. The primary endpoint was percent changes of serum alanine aminotransferase(ALT) levels at 24-week of administration compared to pre-administration levels and secondary endpoints, serum aspartate aminotransferase(AST) and gamma-glutamyltranspeptidase(gamma-GTP) levels. Further, changes of bile acid composition and HCV-RNA levels at 24-week of administration were examined.
- Conditions
- Chronic Hepatitis C
- Being tested
- Ursodeoxycholic acid 150mg / day, Ursodeoxycholic acid 600mg / day, Ursodeoxycholic acid 900mg / day
- Keywords
- Chronic hepatitis C, Ursodeoxycholic acid
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ursodeoxycholic acid 150mg / dayDrug
Ursodeoxycholic acid, 150mg/ day, three times a day at meals
Ursodeoxycholic acid 600mg / dayDrug
Ursodeoxycholic acid, 600mg/ day, three times a day at meals
Ursodeoxycholic acid 900mg / dayDrug
Ursodeoxycholic acid, 900mg/ day, three times a day at meals
| Study group | Role | What they receive |
|---|---|---|
| Ursodeoxycholic acid 150mg / day | Experimental | Not described Receives: Drug: Ursodeoxycholic acid 150mg / day |
| Ursodeoxycholic acid 600mg / day | Experimental | Not described Receives: Drug: Ursodeoxycholic acid 600mg / day |
| Ursodeoxycholic acid 900mg / day | Experimental | Not described Receives: Drug: Ursodeoxycholic acid 900mg / day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alanine Aminotransferase at Baseline
Measured: 0 week
Percentage Change of Alanine Aminotransferase From Baseline at Week 24
Percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100
Measured: 24 weeks (from baseline to Week 24)
Secondary outcomes (4)
Aspartate Aminotransferase at Baseline
Measured: 0 week
Percentage Change of Aspartate Aminotransferase From Baseline at Week 24
Percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100
Measured: 24 weeks (from baseline to Week 24)
Gamma-glutamyl Transpeptidase at Baseline
Measured: 0 week
Percentage Change of Gamma-glutamyl Transpeptidase From Baseline at Week 24
Percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100
Measured: 24 weeks (from baseline to Week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJul 2002
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis CStudies 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
- Enrolment
- 596 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Masao Omata, MD, Study chair, Department of Gastroenterology, University of Tokyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200343
- Sponsor's protocol ID
- MT711-01
- Status last verified
- Dec 2025
- First submitted
- 12 Sep 2005
- Last updated
- 7 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Omata M, Yoshida H, Toyota J, Tomita E, Nishiguchi S, Hayashi N, Iino S, Makino I, Okita K, Toda G, Tanikawa K, Kumada H; Japanese C-Viral Hepatitis Network. A large-scale, multicentre, double-blind trial of ursodeoxycholic acid in patients with chronic hepatitis C. Gut. 2007 Dec;56(12):1747-53. doi: 10.1136/gut.2007.120956. Epub 2007 Jun 15.
PubMed 17573387
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-week Multicenter Double-blind Control Trial With Ursodeoxycholic Acid in Patients With Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT00200343
- Acronym / sponsor ID
- MT711-01
- Conditions
- Chronic Hepatitis C
- Keywords
- Chronic hepatitis C, Ursodeoxycholic acid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 596 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- Study completion
- Dec 2004
- First posted
- 20 Sep 2005 (estimated)
- Results
- Posted 7 Nov 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a 24-week multicenter, randomized, double-blind control trial with ursodeoxycholic acid (UDCA) in patients with chronic hepatitis C in Japan. The primary objectives of this study are to verify the superiority of efficacy of UDCA 600 or 900mg/day to that of 150mg/day and the safety of UDCA treatment.
Detailed description
This study is a 24-week multicenter, randomized, double-blind control trial with ursodeoxycholic acid (UDCA) in patients with chronic hepatitis C in Japan. The primary objectives of this study are to verify the superiority of efficacy of UDCA 600 or 900mg/day to that of 150mg/day and the safety of UDCA treatment. The primary endpoint was percent changes of serum alanine aminotransferase(ALT) levels at 24-week of administration compared to pre-administration levels and secondary endpoints, serum aspartate aminotransferase(AST) and gamma-glutamyltranspeptidase(gamma-GTP) levels. Further, changes of bile acid composition and HCV-RNA levels at 24-week of administration were examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ursodeoxycholic acid 150mg / day | Experimental | Drug: Ursodeoxycholic acid 150mg / day |
| Ursodeoxycholic acid 600mg / day | Experimental | Drug: Ursodeoxycholic acid 600mg / day |
| Ursodeoxycholic acid 900mg / day | Experimental | Drug: Ursodeoxycholic acid 900mg / day |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject must have a clinical diagnosis to apply the conservative medication for chronic hepatitis C.
- Serum alanine aminotransferase levels measured at 4-week before the initiation of treatment must be over 61 IU/mL.
- Subject's age must be 20 years or older.
Key exclusion criteria (11 listed)
- Subject who received a treatment of antiviral agents (interferon) within 20 weeks before the start of 8-week observation period
- Subject who received a treatment of corticosteroids, immunosuppressive drugs, glycyrrhizic acid, cholestyramine or other drugs which could interfere with hepatic function during 8-week observation period.
- Subject with decompensated cirrhosis
- Subject infecting with other hepatic virus
- Subject receiving a treatment for autoimmune disease, alcohol or drug-induced hepatic disorder, neoplasia, hepato-cholangiolar disease, fulminant hepatitis or peptic ulcer
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 |
|---|---|---|
| Ursodeoxycholic acid 150mg / dayUrsodeoxycholic acid, 150mg/ day, three times a day at meals | Drug | Ursodeoxycholic acid 150mg / day |
| Ursodeoxycholic acid 600mg / dayUrsodeoxycholic acid, 600mg/ day, three times a day at meals | Drug | Ursodeoxycholic acid 600mg / day |
| Ursodeoxycholic acid 900mg / dayUrsodeoxycholic acid, 900mg/ day, three times a day at meals | Drug | Ursodeoxycholic acid 900mg / day |
Primary outcome
Alanine Aminotransferase at Baseline
Time frame: 0 week
Percentage Change of Alanine Aminotransferase From Baseline at Week 24
Time frame: 24 weeks (from baseline to Week 24)
Percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100
4 secondary outcomes
Aspartate Aminotransferase at Baseline
Time frame: 0 week
Percentage Change of Aspartate Aminotransferase From Baseline at Week 24
Time frame: 24 weeks (from baseline to Week 24)
Gamma-glutamyl Transpeptidase at Baseline
Time frame: 0 week
Percentage Change of Gamma-glutamyl Transpeptidase From Baseline at Week 24
Time frame: 24 weeks (from baseline to Week 24)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 17573387Omata M, Yoshida H, Toyota J, Tomita E, Nishiguchi S, Hayashi N, Iino S, Makino I, Okita K, Toda G, Tanikawa K, Kumada H; Japanese C-Viral Hepatitis Network. A large-scale, multicentre, double-blind trial of ursodeoxycholic acid in patients with chronic hepatitis C. Gut. 2007 Dec;56(12):1747-53. doi: 10.1136/gut.2007.120956. Epub 2007 Jun 15.
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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.
Masao Omata, MD study chair
Department of Gastroenterology, University of Tokyo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ursodeoxycholic acid 150mg / day, Ursodeoxycholic acid 600mg / day and Ursodeoxycholic acid 900mg / day in people with Chronic Hepatitis C, run by Tanabe Pharma Corporation at 1 site in Japan.
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 11 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 7 Jan 2026. 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 Japan. 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?
Yes. Results are posted in the registry (first posted 7 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Alanine Aminotransferase at Baseline (time frame: 0 week). The study lists 2 primary outcomes in all. 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 NCT00200343, which also lists 1 linked publication.
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 7 Jan 2026.