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Also known as Adefovir Dipivoxil (ADV)
Adefovir dipivoxil · 8 trials · 4 indications
In the absence of biopsy data from these pediatric participants, this endpoint enables assessments of drug effect on viral replication and the underlying degree of inflammation in the liver.
Determined by positive hepatitis B serology (tests positive for HBsAg) and HBV DNA viral load (\>40 IU/mL).
| Arm | Type | Description |
|---|---|---|
| Placebo (PLB) | PLACEBO_COMPARATOR | Participants randomized to receive placebo received placebo during the first 48 weeks of treatment (double-blind phase) and then all eligible participants were administered open-label ADV for the remainder of the study. |
| Adefovir Dipivoxil (ADV) | EXPERIMENTAL | Participants randomized to receive ADV received ADV during the first 48 weeks of treatment (double-blind phase) and then all eligible participants were administered open-label ADV for the remainder of the study. |
| Treatment Arm 1 | OTHER | Adefovir dipivoxil 10 mg once daily with tacrolimus or cyclosporine for 14 days |
| ADV plus hepatitis B vaccination | EXPERIMENTAL | Adefovir dipivoxil and hepatitis B vaccination: All subjects will receive adefovir 10mg po daily, or adjusted for renal function and an option for Hepatitis B vaccination, double dose. |
| Treatment Group A | OTHER | ADV (0.14 mg/kg) oral suspension formulation on Day 1 followed by ADV (0.3 mg/kg) oral suspension formulation on Day 8 in 2-6 and 7-11 year old age group |
| Treatment Group B | OTHER | ADV (0.3 mg/kg) oral suspension formulation on Day 1 followed by ADV (0.14 mg/kg) oral suspension formulation on Day 8 in 2-6 and 7-11 year old age group |
| Treatment Group C | OTHER | ADV 10 mg single dose on Day 1 in 12-17 year old age group |
| Name | Type | Description |
|---|---|---|
| Placebo (PLB) | DRUG | Matching placebo |
| Adefovir Dipivoxil (ADV) | DRUG | 10-mg tablet or 2-mg/mL oral suspension |
| Lamivudine | DRUG | 100-mg tablet administered according to package labeling. Lamivudine was to be added to the open-label ADV regimen of subjects with a serum HBV DNA concentration \>= 1000 copies/mL at 2 consecutive study visits at or after Study Week 96. If the HBV DNA concentration remained \>= 1000 copies/mL at 2 consecutive study visits after the addition of lamivudine, the investigator was required to discontinue all study drugs, perform the early termination ssessments, and have the subject return every 4 weeks for 16 weeks of posttreatment evaluations. |
| Adefovir Dipivoxil for oral suspension, 2 mg/mL | DRUG | - |
| Adefovir Dipivoxil | DRUG | Adefovir dipivoxil 10 mg once daily for 14 days co-administered with tacrolimus or cyclosporine |
| Adefovir dipivoxil and hepatitis B vaccination | DRUG | Adefovir 10mg po daily, or adjusted for renal function and option for Hepatitis B vaccination, double dose |
Key Inclusion Criteria: * Positive HBsAg \>= 6 months prior to randomization and positive HBeAg at screening. * Serum HBV DNA greater than or equal to 1 x 100,000 copies/mL (PCR assay) at initial or confirmatory screening visit. * Serum ALT levels greater than or equal to 1.5 x ULN at both initial ...
Adefovir dipivoxil is a small molecule antiviral drug developed by Gilead Sciences, Inc. (ticker GILD) for infectious disease. It is studied in chronic hepatitis B, hepatitis B, and HIV infections. It is given orally, including as a 2 mg/mL oral suspension, and has been evaluated in placebo-controlled, randomized, double-blind clinical trials.
Adefovir dipivoxil is used for the treatment of chronic hepatitis B, and it has also been studied in hepatitis B and HIV infections. Its clinical program includes a Phase 3 trial in children and adolescents with chronic hepatitis B, as well as pharmacokinetic and safety studies in liver transplant patients.
Adefovir dipivoxil is developed by Gilead Sciences, Inc., which trades under the ticker GILD. Gilead is the company associated with the drug's clinical development across its hepatitis B and HIV infection programs.
Adefovir dipivoxil has reached Phase 3 development. Its Phase 3 trial was a safety and efficacy study in children and adolescents with chronic hepatitis B. Additional completed studies include Phase 1 and Phase 2 trials, and no trials are currently active.
Adefovir dipivoxil has been studied in completed trials including NCT00095121, a Phase 3 safety and efficacy study in children and adolescents with chronic hepatitis B; NCT00645294, a Phase 1 pharmacokinetics and safety study in children and adolescents with HBV; NCT00644761, a Phase 2 drug interaction study in post-liver transplant patients; and NCT01146808, a Phase 1 study of adefovir plus vaccination in transplant patients.
Yes. Adefovir dipivoxil is also known as ADV, and it is supplied as adefovir dipivoxil for oral suspension at 2 mg/mL. Related search terms include adefovir dipivoxil and hepatitis B vaccination, reflecting trial combinations of the drug with hepatitis B vaccination.