Clinical trial NCT00200343: Efficacy and Safety Study of Ursodeoxycholic Acid to Treat Chronic Hepatitis C
Official title: A 24-week Multicenter Double-blind Control Trial With Ursodeoxycholic Acid in Patients With Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C
Keywords: Chronic hepatitis C, Ursodeoxycholic acid
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 596
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Alanine Aminotransferase at Baseline
timeFrame: 0 week
measure: Percentage Change of Alanine Aminotransferase From Baseline at Week 24
timeFrame: 24 weeks (from baseline to Week 24)
Secondary outcomes:
measure: Aspartate Aminotransferase at Baseline
timeFrame: 0 week
measure: Percentage Change of Aspartate Aminotransferase From Baseline at Week 24
timeFrame: 24 weeks (from baseline to Week 24)
measure: Gamma-glutamyl Transpeptidase at Baseline
timeFrame: 0 week
measure: Percentage Change of Gamma-glutamyl Transpeptidase From Baseline at Week 24
timeFrame: 24 weeks (from baseline to Week 24)
Other outcomes:
Locations:
city: hongo, bunkyo-ku, Tokyo
country: Japan
facility: Department of Gastroenterology, University of Tokyo
Study officials:
affiliation: Department of Gastroenterology, University of Tokyo
name: Masao Omata, MD
role: STUDY_CHAIR
References:
citation: 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.