Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Adefovir Dipivoxil for, mL · 2 trials · 1 indication
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.
| 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. |
| 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 | - |
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 an investigational small molecule being developed for HIV infections, Hepatitis B, and Chronic Hepatitis B. It is a nucleotide analog reverse transcriptase inhibitor that has been studied in Phase 3 clinical trials for chronic Hepatitis B. The drug is not approved and remains in clinical development.
Adefovir Dipivoxil targets hepatitis B virus reverse transcriptase, an enzyme essential for viral replication. By inhibiting this enzyme, the drug aims to suppress viral DNA synthesis and reduce hepatitis B viral load in infected patients. This mechanism is relevant to its use in treating chronic Hepatitis B infections.
Adefovir Dipivoxil is developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker GILD. Gilead has conducted multiple clinical trials of this drug for chronic Hepatitis B, including studies in adult and pediatric populations.
Adefovir Dipivoxil has completed Phase 3 clinical trials for chronic Hepatitis B, with three completed trials involving 221 total participants. However, the drug is still investigational and has not received FDA approval. Its development status is not specified beyond these completed trials.
Adefovir Dipivoxil has been studied in completed trials including NCT00071201, a Phase 3 study of a liquid suspension in 48 adults with chronic Hepatitis B, and NCT00095121, a Phase 3 trial in 173 children and adolescents. Additional Phase 1 studies include NCT00645294 and NCT01146808.
Adefovir Dipivoxil is the generic name for the drug also known as Hepsera, which is a brand name used for adefovir dipivoxil. The drug is being developed by Gilead Sciences for chronic Hepatitis B and has been evaluated in clinical trials under the name Adefovir Dipivoxil.