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

NCT00200343 | Completed Phase 3 Results

• 1 other identifier: MT711-01
• Study Type: interventional
• Target: 596
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis C

Keywords

Chronic hepatitis C, Ursodeoxycholic acid

Outcome Measures

Primary Outcomes (2)

• Alanine Aminotransferase at Baseline

  0 week

• 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

  24 weeks (from baseline to Week 24)

Secondary Outcomes (4)

• Aspartate Aminotransferase at Baseline

  0 week

• Percentage Change of Aspartate Aminotransferase From Baseline at Week 24

  24 weeks (from baseline to Week 24)

• Gamma-glutamyl Transpeptidase at Baseline

  0 week

• Percentage Change of Gamma-glutamyl Transpeptidase From Baseline at Week 24

  24 weeks (from baseline to Week 24)

Study Arms (3)

Ursodeoxycholic acid 150mg / day

EXPERIMENTAL

Drug: Ursodeoxycholic acid 150mg / day

Ursodeoxycholic acid 600mg / day

EXPERIMENTAL

Drug: Ursodeoxycholic acid 600mg / day

Ursodeoxycholic acid 900mg / day

EXPERIMENTAL

Drug: Ursodeoxycholic acid 900mg / day

Interventions

Ursodeoxycholic acid 600mg / day DRUG

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

Ursodeoxycholic acid 600mg / day

Ursodeoxycholic acid 900mg / day DRUG

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

Ursodeoxycholic acid 900mg / day

Ursodeoxycholic acid 150mg / day DRUG

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

Ursodeoxycholic acid 150mg / day

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (1)

Department of Gastroenterology, University of Tokyo

Hongo, Bunkyo-ku, Tokyo, Japan

Location

Related Publications (1)

• 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.

  PMID: 17573387 RESULT

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma Corporation

cti-inq-ml.JP@ml.tanabe-pharma.com

Study Officials

• Masao Omata, MD

  Department of Gastroenterology, University of Tokyo

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: July 1, 2002
• Study Completion: December 1, 2004
• Last Updated: January 7, 2026
• Results First Posted: November 7, 2011

Record last verified: 2025-12

Locations

JP (1)