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Nucleoside Reverse Transcriptase Inhibitor

Clevudine for Hepatitis B

Phase 2
Waitlist Available
Research Sponsored by Triangle Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
HBV DNA positive with DNA levels at screening greater than or equal to 3,000,000 copies/mL
HBeAg positive and anti-HBe negative OR HBeAg negative (pre-core mutant) and anti-HBe positive with positive HBsAg for the previous 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing a potential new hepatitis B treatment to see if it is safe and effective.

Who is the study for?
This trial is for adults with chronic hepatitis B virus infection, having high viral DNA levels and positive HBsAg status for over 6 months. They should not have cirrhosis or liver cancer, no recent interferon treatment, and no co-infection with HCV or HIV. Participants must not be on antiviral or immunomodulatory therapy.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of a drug called clevudine in three different doses over a period of 12 weeks to treat patients with chronic hepatitis B virus infection.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions to clevudine which could include typical drug-related issues such as digestive discomfort, fatigue, allergic reactions or changes in liver function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My HBV DNA levels are 3 million copies/mL or more.
Select...
I have a specific type of hepatitis B infection.
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My bilirubin levels are within the normal range, or I have Gilbert's disease with normal conjugated bilirubin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Find a Location

Who is running the clinical trial?

Triangle PharmaceuticalsLead Sponsor
11 Previous Clinical Trials
929 Total Patients Enrolled

Media Library

Clevudine (Nucleoside Reverse Transcriptase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00044135 — Phase 2
Hepatitis B Research Study Groups:
Hepatitis B Clinical Trial 2023: Clevudine Highlights & Side Effects. Trial Name: NCT00044135 — Phase 2
Clevudine (Nucleoside Reverse Transcriptase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00044135 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you detail the risks associated with this treatment method?

"While Phase 2 trials don't have efficacy data, there is some safety data from other studies supporting this intervention. For that reason, Power gave it a score of 2."

Answered by AI

Are patients being actively recruited for participation in this trial?

"The clinical trial mentioned is not seeking new patients at this time, as the last update was in 2005. However, there are plenty of other medical studies recruiting volunteers right now."

Answered by AI

Does this research project welcome participants who are below the age of 25?

"This trial is designed for people who are 18-60 years old. If you don't fit this age criteria, there are other options available: 30 trials exist for those under 18 and 246 trials focus on patients 65 and older."

Answered by AI

How can I become involved in this research project?

"Up to 30 individuals that have hepatitis b and are between 18-60 years old may be admitted into this trial. Furthermore, all participants must meet the following additional conditions: a positive HBsAg status for more than 6 months OR a positive HBsAg status with a negative anti-HBc IgM and anti-HBs or,positive HBeAg status with a negative anti-HBe ,or negative HBeAg (pre-core mutant)status with a positive anti-HBe in addition to being HBsAg positive for the past 6 months."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Hospital St Louis, Service de Medecine Interne
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Safety Study to Evaluate 12 Weeks of Treatment with Clevudine in Patients Infected with Hepatitis B Virus.
2002. "A Safety Study to Evaluate 12 Weeks of Treatment with Clevudine in Patients Infected with Hepatitis B Virus.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00044135.
All > Autoimmune Hepatitis > Cte
~1 spots leftby Apr 2025
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