Safety and Antiviral Activity Study of ACH-126,443 (Beta-L-Fd4C) in Treatment-naive Adults With C… (NCT00034359) | Clinical Trial Compass
CompletedPhase 2
Safety and Antiviral Activity Study of ACH-126,443 (Beta-L-Fd4C) in Treatment-naive Adults With Chronic Hepatitis B Virus Infection
Bulgaria, Federal Republic of Yugoslavia79 participantsStarted 2002-02
Plain-language summary
The purpose of this study was to determine the safety and anti-hepatitis B virus (-HBV) activity of ACH-126,443 in comparison to lamivudine or placebo in treatment-naive adults with chronic hepatitis B infection.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Chronic hepatitis B virus (HBV) infection, known to be hepatitis B surface antigen positive ≥ 6 months.
* Plasma HBV deoxyribonucleic acid level ≥ 100,000 copies/milliliter.
* Hepatitis B e-antigen positive.
* Human immunodeficiency virus negative.
* Basic hematologic and chemistry parameters within acceptable limits (defined in protocol).
* No need for excluded medications.
* Participants of reproductive capability must have utilized 2 approved forms of birth control, one of which must have been barrier protection.
Exclusion Criteria:
* Human immunodeficiency virus infection.
* Hepatitis C co-infection.
* Concurrent systemic antiviral treatment.
* Previous antiviral treatment for HBV infection within 6 months prior to randomization or treatment with lamivudine for more than 6 months at any time in the past.
* Previous therapy with agents with significant systemic myelosuppressive or cytotoxic potential within 3 months of study start or the expected need for such therapy at study start.
* Alcohol abuse.
* Pregnancy or breast-feeding.
* Inability to tolerate oral medication.
* Aspartate aminotransferase \> 7.0 times the upper limit of normal.
* Alanine aminotransferase \> 7.0 times the upper limit of normal.
* Any clinical condition or prior therapy that, in the Investigators opinion, would make the participant unsuitable for the study or unable to comply with the dosing requirements.
* Use of any investigational drug.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.