Safety and Antiviral Study of ACH126, 433 (b-L-Fd4C) in Adults With Lamivudine-resistant Chronic … (NCT00040144) | Clinical Trial Compass
TerminatedPhase 2
Safety and Antiviral Study of ACH126, 433 (b-L-Fd4C) in Adults With Lamivudine-resistant Chronic Hepatitis B
Stopped: Safety concerns
United States, Canada, China85 participantsStarted 2002-07
Plain-language summary
The purpose of this study was to determine the safety and antiviral hepatitis B virus (HBV) activity of ACH126, 433 in the treatment of adults with lamivudine-resistant chronic hepatitis B.
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 HBV infection, known to be hepatitis B surface antigen (HbsAg) positive ≥ 6 months
* On lamivudine, either 100 or 150 milligrams daily for the treatment of chronic hepatitis B infection and exhibit a 2-3 log decrease in HBV deoxyribonucleic acid (DNA) levels followed by a rebound of at least 1.5 log HBV DNA or
* Achieved an HBV DNA level of \< 10,000 copies/milliliter (mL) HBV DNA on at least 2 occasions and have rebounded to \> 100,000 copies/mL HBV DNA, or
* Have a demonstrable lamivudine -resistant genotype regardless of treatment history.
* Hepatitis B e-antigen positive.
* Human immunodeficiency virus (HIV) negative.
* Serum alanine aminotransferase ≥ 1.5 and ≤ 10x times the upper limit of normal (ULN).
* Hemoglobin ≥ 10 grams/deciliter or hematocrit ≥ 30% (in the absence of blood transfusions or erythropoietin treatment in the preceding 2 weeks).
* Platelet count \>75,000/cubic millimeters (in the absence of ongoing granulocyte colony-stimulating factor therapy).
* Serum creatinine \< 1.1x the ULN.
* Negative radiologic screening test (ultrasound, computerized tomography scan, or magnetic resonance imaging) for hepatocellular carcinoma within 6 months prior to entry.
* Prothrombin time/international normalize ratio \< 2.
* Participants of reproductive capability must utilize an approved form of birth control.
* All women of child-bearing capability must have a negative serum or urine pregnancy test (minimum sensitivity of 24 internatio…
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.