CompletedPhase 3

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

Japan596 participantsStarted 2002-07

Plain-language 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.

Who can participate

Age range20 Years

SexALL

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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

What they're measuring

Alanine Aminotransferase at Baseline

Timeframe: 0 week

Percentage Change of Alanine Aminotransferase From Baseline at Week 24

Timeframe: 24 weeks (from baseline to Week 24)

Trial details

NCT IDNCT00200343

SponsorTanabe Pharma Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Results submitted2011-08-17

View on ClinicalTrials.gov More Chronic Hepatitis C trials