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CompletedNCT00200343Updated Jan 7, 2026Results posted

Efficacy and Safety Study of Ursodeoxycholic Acid to Treat Chronic Hepatitis C

A Phase 3 interventional study of Ursodeoxycholic acid 150mg / day and Ursodeoxycholic acid 600mg / day in Chronic Hepatitis C, sponsored by Tanabe Pharma Corporation. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-01-07.

Sponsored by Tanabe Pharma Corporation · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
596
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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 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.

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Conditions studied

  • Chronic Hepatitis C

Keywords

  • Chronic hepatitis C, Ursodeoxycholic acid
03

In context

Hepatitis C, Chronic

1,073 studies on the registry are indexed under Hepatitis C, Chronic; 9 are open to participants now.

This study's enrollment of 596 is above the median of 90 across 775 interventional studies indexed under Hepatitis C, Chronic.

Browse Hepatitis C, Chronic studies →

Lead sponsor

Tanabe Pharma Corporation is the lead sponsor of 91 studies on the registry; 1 is open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Subject must have a clinical diagnosis to apply the conservative medication for chronic hepatitis C.
  2. Serum alanine aminotransferase levels measured at 4-week before the initiation of treatment must be over 61 IU/mL.
  3. Subject's age must be 20 years or older.

Exclusion criteria

Exclusion Criteria:

  1. Subject who received a treatment of antiviral agents (interferon) within 20 weeks before the start of 8-week observation period
  2. 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.
  3. Subject with decompensated cirrhosis
  4. Subject infecting with other hepatic virus
  5. Subject receiving a treatment for autoimmune disease, alcohol or drug-induced hepatic disorder, neoplasia, hepato-cholangiolar disease, fulminant hepatitis or peptic ulcer
  6. Subject who require hospitalization for complications of the heart, kidney or pancreas
  7. Pregnancy
  8. Alcoholics
  9. Alcohol intake more than 27 ml/day
  10. Subject who involved in other clinical trial within 4 weeks before the start of observation period
  11. Subject with a history of sensitivity to ursodeoxycholic acid or bile acid-products
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
596 participants (actual)

Study arms

  • Experimental
    Ursodeoxycholic acid 150mg / day

    Drug: Ursodeoxycholic acid 150mg / day

  • Experimental
    Ursodeoxycholic acid 600mg / day

    Drug: Ursodeoxycholic acid 600mg / day

  • Experimental
    Ursodeoxycholic acid 900mg / day

    Drug: Ursodeoxycholic acid 900mg / day

Interventions

  • DrugUrsodeoxycholic acid 150mg / day

    Ursodeoxycholic acid, 150mg/ day, three times a day at meals

  • DrugUrsodeoxycholic acid 600mg / day

    Ursodeoxycholic acid, 600mg/ day, three times a day at meals

  • DrugUrsodeoxycholic acid 900mg / day

    Ursodeoxycholic acid, 900mg/ day, three times a day at meals

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What researchers measure

Primary outcomes

  1. Alanine Aminotransferase at Baseline

    Time frame: 0 week

  2. 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

    Time frame: 24 weeks (from baseline to Week 24)

Secondary outcomes

  1. Aspartate Aminotransferase at Baseline

    Time frame: 0 week

  2. 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

    Time frame: 24 weeks (from baseline to Week 24)

  3. Gamma-glutamyl Transpeptidase at Baseline

    Time frame: 0 week

  4. 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

    Time frame: 24 weeks (from baseline to Week 24)

07

Results

Posted Nov 7, 2011

Participant flow

Participant flow — Overall Study
Milestone150mg / Day600mg / Day900mg / Day
Started199200197
Completed183192184
Not completed16813

Outcome measures

PrimaryAlanine Aminotransferase at Baseline
Time frame:
0 week
Reported as:
Mean · IU/L
Alanine Aminotransferase at Baseline
IU/L150mg / Day600mg / Day900mg / Day
Alanine Aminotransferase at Baseline109.2 ± 49.7106.3 ± 59.4110.6 ± 57.3
SecondaryAspartate Aminotransferase at Baseline
Time frame:
0 week
Reported as:
Mean · IU/L
Aspartate Aminotransferase at Baseline
IU/L150mg / Day600mg / Day900mg / Day
Aspartate Aminotransferase at Baseline84.0 ± 39.182.4 ± 41.885.2 ± 45.0
SecondaryPercentage 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

Time frame:
24 weeks (from baseline to Week 24)
Reported as:
Median · Percentage of change
Percentage Change of Aspartate Aminotransferase From Baseline at Week 24
Percentage of change150mg / Day600mg / Day900mg / Day
Percentage Change of Aspartate Aminotransferase From Baseline at Week 24-13.6 (-74.2 to 347.2)-25.0 (-82.7 to 72.5)-29.8 (-79.0 to 1026.1)
SecondaryGamma-glutamyl Transpeptidase at Baseline
Time frame:
0 week
Reported as:
Mean · IU/L
Gamma-glutamyl Transpeptidase at Baseline
IU/L150mg / Day600mg / Day900mg / Day
Gamma-glutamyl Transpeptidase at Baseline87.5 ± 73.082.4 ± 62.285.9 ± 66.3
PrimaryPercentage 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

Time frame:
24 weeks (from baseline to Week 24)
Reported as:
Median · Percentage of change
Percentage Change of Alanine Aminotransferase From Baseline at Week 24
Percentage of change150mg / Day600mg / Day900mg / Day
Percentage Change of Alanine Aminotransferase From Baseline at Week 24-15.3 (-80.7 to 375.9)-29.2 (-88.3 to 95.2)-36.2 (-81.4 to 1696.9)
SecondaryPercentage 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

Time frame:
24 weeks (from baseline to Week 24)
Reported as:
Median · Percentage of change
Percentage Change of Gamma-glutamyl Transpeptidase From Baseline at Week 24
Percentage of change150mg / Day600mg / Day900mg / Day
Percentage Change of Gamma-glutamyl Transpeptidase From Baseline at Week 24-22.4 (-74.6 to 145.9)-41.0 (-81.1 to 153.1)-50.0 (-80.1 to 213.9)

Adverse events

Collected over The reported adverse event data were collected for 24 weeks.. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
150mg / Day—9/199 (4.5%)130/199 (65.3%)
600mg / Day—8/200 (4%)122/200 (61%)
900mg / Day—9/197 (4.6%)119/197 (60.4%)
Most frequent serious events
Showing 10 of 20
Most frequent serious events
Event150mg / Day600mg / Day900mg / Day
Colonic polypGastrointestinal disorders2/1990/2001/197
Hepatic neoplasm malignant NOSNeoplasms benign, malignant and unspecified (incl cysts and polyps)2/1992/2001/197
Diverticulum intestinal haemorrhagicGastrointestinal disorders0/1990/2001/197
EnterocolitisGastrointestinal disorders0/1990/2001/197
Inguinal hernia NOSGastrointestinal disorders0/1990/2001/197
Hepatic cirrhosis NOSHepatobiliary disorders0/1991/2001/197
Renal neoplasm NOSNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/1990/2001/197
Subarachnoid haemorrhage NOSNervous system disorders0/1990/2001/197
Lumbar spinal stenosisNervous system disorders0/1990/2001/197
Appendicitis perforatedGastrointestinal disorders1/1990/2000/197
Most frequent other events
Showing 10 of 27
Most frequent other events
Event150mg / Day600mg / Day900mg / Day
NasopharyngitisInfections and infestations51/19949/20052/197
Diarrhoea NOSGastrointestinal disorders9/19912/20015/197
StomatitisGastrointestinal disorders1/1991/2007/197
Abdominal pain upperGastrointestinal disorders3/1995/2006/197
ConstipationGastrointestinal disorders4/1994/2006/197
Stomach discomfortGastrointestinal disorders3/1993/2006/197
HeadacheNervous system disorders6/1996/2006/197
DizzinessNervous system disorders6/1991/2003/197
Cystitis NOSRenal and urinary disorders6/1990/2004/197
PruritusSkin and subcutaneous tissue disorders6/1993/2004/197

Baseline characteristics

Age, Continuous
Age, Continuous(years)150mg / Day600mg / Day900mg / DayTotal
Mean58.0 ± 12.257.7 ± 12.059.8 ± 10.158.4 ± 11.5
Sex: Female, Male
Sex: Female, Male(Participants)150mg / Day600mg / Day900mg / DayTotal
Female988170249
Male97117123337
08

Study locations

1 site
  • Department of Gastroenterology, University of Tokyo
    Hongo, Bunkyo-ku, Tokyo, Japan
09

References and documents

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 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00200343
Lead sponsor
Tanabe Pharma Corporation
First posted
Sep 20, 2005
Start date
Jul 2002
Completion
Dec 2004
Results posted
Nov 7, 2011
Last update
Jan 7, 2026

Study contacts

Masao Omata, MD
study chair · Department of Gastroenterology, University of Tokyo
View the source record on ClinicalTrials.gov ↗

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