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

A 24-week Multicenter Double-blind Control Trial With Ursodeoxycholic Acid in Patients With Chronic Hepatitis C

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00200343
Enrollment
596
Registered
2005-09-20
Start date
2002-07-31
Completion date
2004-12-31
Last updated
2026-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

Keywords

Chronic hepatitis C, Ursodeoxycholic acid

Brief 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.

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.

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

Sponsors

Tanabe Pharma Corporation
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
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

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

Design outcomes

Primary

MeasureTime frameDescription
Alanine Aminotransferase at Baseline0 week—
Percentage Change of Alanine Aminotransferase From Baseline at Week 2424 weeks (from baseline to Week 24)Percentage change=\[(measured value at Week 24 - measured value at baseline)/measured value at baseline\]\*100

Secondary

MeasureTime frameDescription
Aspartate Aminotransferase at Baseline0 week—
Percentage Change of Aspartate Aminotransferase From Baseline at Week 2424 weeks (from baseline to Week 24)Percentage change=\[(measured value at Week 24 - measured value at baseline)/measured value at baseline\]\*100
Gamma-glutamyl Transpeptidase at Baseline0 week—
Percentage Change of Gamma-glutamyl Transpeptidase From Baseline at Week 2424 weeks (from baseline to Week 24)Percentage change=\[(measured value at Week 24 - measured value at baseline)/measured value at baseline\]\*100

Countries

Japan

Participant flow

Participants by arm

ArmCount
150mg / Day
ursodeoxycholic acid, 150mg/day, three times a day at meals
195
600mg / Day
ursodeoxycholic acid, 600mg/day, three times a day at meals
198
900mg / Day
ursodeoxycholic acid, 900mg/day, three times a day at meals
193
Total586

Baseline characteristics

Characteristic150mg / Day600mg / Day900mg / DayTotal
Age, Continuous58.0 years
STANDARD_DEVIATION 12.2
57.7 years
STANDARD_DEVIATION 12
59.8 years
STANDARD_DEVIATION 10.1
58.4 years
STANDARD_DEVIATION 11.5
Sex: Female, Male
Female
98 Participants81 Participants70 Participants249 Participants
Sex: Female, Male
Male
97 Participants117 Participants123 Participants337 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
130 / 199122 / 200119 / 197
serious
Total, serious adverse events
9 / 1998 / 2009 / 197

Outcome results

Primary

Alanine Aminotransferase at Baseline

Time frame: 0 week

Population: 10 patients were excluded from analysis population due to luck of sufficient data.

ArmMeasureValue (MEAN)Dispersion
150mg / DayAlanine Aminotransferase at Baseline109.2 IU/LStandard Deviation 49.7
600mg / DayAlanine Aminotransferase at Baseline106.3 IU/LStandard Deviation 59.4
900mg / DayAlanine Aminotransferase at Baseline110.6 IU/LStandard Deviation 57.3
Primary

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)

Population: percentage change=\[(measured value at Week 24 - measured value at baseline)/measured value at baseline\]\*100

ArmMeasureValue (MEDIAN)
150mg / DayPercentage Change of Alanine Aminotransferase From Baseline at Week 24-15.3 Percentage of change
600mg / DayPercentage Change of Alanine Aminotransferase From Baseline at Week 24-29.2 Percentage of change
900mg / DayPercentage Change of Alanine Aminotransferase From Baseline at Week 24-36.2 Percentage of change
Secondary

Aspartate Aminotransferase at Baseline

Time frame: 0 week

ArmMeasureValue (MEAN)Dispersion
150mg / DayAspartate Aminotransferase at Baseline84.0 IU/LStandard Deviation 39.1
600mg / DayAspartate Aminotransferase at Baseline82.4 IU/LStandard Deviation 41.8
900mg / DayAspartate Aminotransferase at Baseline85.2 IU/LStandard Deviation 45
Secondary

Gamma-glutamyl Transpeptidase at Baseline

Time frame: 0 week

ArmMeasureValue (MEAN)Dispersion
150mg / DayGamma-glutamyl Transpeptidase at Baseline87.5 IU/LStandard Deviation 73
600mg / DayGamma-glutamyl Transpeptidase at Baseline82.4 IU/LStandard Deviation 62.2
900mg / DayGamma-glutamyl Transpeptidase at Baseline85.9 IU/LStandard Deviation 66.3
Secondary

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)

ArmMeasureValue (MEDIAN)
150mg / DayPercentage Change of Aspartate Aminotransferase From Baseline at Week 24-13.6 Percentage of change
600mg / DayPercentage Change of Aspartate Aminotransferase From Baseline at Week 24-25.0 Percentage of change
900mg / DayPercentage Change of Aspartate Aminotransferase From Baseline at Week 24-29.8 Percentage of change
Secondary

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)

Population: percentage change=\[(measured value at Week 24 - measured value at baseline)/measured value at baseline\]\*100

ArmMeasureValue (MEDIAN)
150mg / DayPercentage Change of Gamma-glutamyl Transpeptidase From Baseline at Week 24-22.4 Percentage of change
600mg / DayPercentage Change of Gamma-glutamyl Transpeptidase From Baseline at Week 24-41.0 Percentage of change
900mg / DayPercentage Change of Gamma-glutamyl Transpeptidase From Baseline at Week 24-50.0 Percentage of change

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026