Phase 3
N=596
Efficacy and Safety Study of Ursodeoxycholic Acid to Treat Chronic Hepatitis C
Chronic Hepatitis C
Bottom Line
View on ClinicalTrials.gov: NCT00200343 ↗Enrolled (actual)
596
Serious AEs
4.4%
Results posted
Nov 2011
Primary outcome: Primary: Alanine Aminotransferase at Baseline — 109.2; 106.3; 110.6 IU/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ursodeoxycholic acid 150mg / day (Drug); Ursodeoxycholic acid 600mg / day (Drug); Ursodeoxycholic acid 900mg / day (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Tanabe Pharma Corporation
- Primary completion
- —
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Alanine Aminotransferase at Baseline |
109.2; 106.3; 110.6 | — |
| PRIMARY Percentage Change of Alanine Aminotransferase From Baseline at Week 24 |
-15.3; -29.2; -36.2 | — |
| SECONDARY Aspartate Aminotransferase at Baseline |
84.0; 82.4; 85.2 | — |
| SECONDARY Percentage Change of Aspartate Aminotransferase From Baseline at Week 24 |
-13.6; -25.0; -29.8 | — |
| SECONDARY Gamma-glutamyl Transpeptidase at Baseline |
87.5; 82.4; 85.9 | — |
| SECONDARY Percentage Change of Gamma-glutamyl Transpeptidase From Baseline at Week 24 |
-22.4; -41.0; -50.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT00200343). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.