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Can a higher dose of a common drug tame hepatitis c?

NCT ID NCT00200343

Disease control Sponsor: Tanabe Pharma Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether higher doses of ursodeoxycholic acid (UDCA) could better lower liver enzymes in 596 adults with chronic hepatitis C. Participants received 150, 600, or 900 mg of UDCA daily for 24 weeks. The main goal was to see if the higher doses were more effective and safe.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ursodeoxycholic acid (UDCA)
What this could lead to
If successful, higher doses of UDCA could help control liver inflammation in people with chronic hepatitis C.
What could go wrong
This trial is completed and focused on liver enzyme changes, not on curing the infection. Results may not lead to a new standard treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

596 people

The number who actually took part.

Start date

Jul 2002

Completion date

Dec 2004

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

chronic hepatitis C virus infection hepatitis C virus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic hepatitis C

Contacts and locations

Locations

  • Department of Gastroenterology, University of Tokyo

    Hongo, Bunkyo-ku, Tokyo, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.