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

Mitsubishi Tanabe Pharma logo

Mitsubishi Tanabe Pharma

Status and phase

Completed
Phase 3

Conditions

Chronic Hepatitis C

Treatments

Drug: Ursodeoxycholic acid 900mg / day
Drug: Ursodeoxycholic acid 150mg / day
Drug: Ursodeoxycholic acid 600mg / day

Study type

Interventional

Funder types

Industry

Identifiers

NCT00200343
MT711-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

596 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

596 participants in 3 patient groups

Ursodeoxycholic acid 150mg / day
Experimental group
Treatment:
Drug: Ursodeoxycholic acid 150mg / day
Ursodeoxycholic acid 600mg / day
Experimental group
Treatment:
Drug: Ursodeoxycholic acid 600mg / day
Ursodeoxycholic acid 900mg / day
Experimental group
Treatment:
Drug: Ursodeoxycholic acid 900mg / day

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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