Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LAM group · 1 trial · 1 indication
Change from baseline was the difference of the HBV DNA copy numbers (log10) in serum collected by blood draw between baseline and Week 52
| Arm | Type | Description |
|---|---|---|
| Adefovir Dipivoxil (ADV) | EXPERIMENTAL | - |
| Lamivudine (LAM) | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| LAM group | DRUG | Subjects took one LAM 100mg tablet orally once daily and one ADV placebo tablet orally once daily. |
| ADV group | DRUG | Subjects took one ADV 10mg tablet orally once daily and one LAM placebo tablet orally once daily. |
Inclusion criteria: * Have compensated chronic hepatitis B. * Have not been treated with anti HBV agents with antiproliferative activity against. However, previous Interferon (IFN) therapy is permitted. * Ability to read, understand, and sign the informed consent. * Have a positive serum HBV-DNA \>...
LAM group is an investigational small molecule being studied for the treatment of chronic Hepatitis B. It is currently in Phase 3 clinical development. The drug is being evaluated in patients with compensated chronic Hepatitis B, a condition where the liver is still functioning but has been infected with the Hepatitis B virus.
LAM group is being developed by GSK plc, a global biopharmaceutical company. GSK plc is publicly traded under the ticker symbol GSK. The company is conducting clinical trials to evaluate the safety and efficacy of LAM group in patients with chronic Hepatitis B.
LAM group is currently in Phase 3 clinical development for chronic Hepatitis B. This is the final stage of testing before a potential regulatory submission. The drug is being studied in a randomized, double-blind, active-controlled trial to assess its effects in patients with compensated chronic Hepatitis B.
LAM group has been studied in one completed Phase 3 clinical trial with the identifier NCT00316719. This trial, titled 'Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients', enrolled 105 participants aged 16 years and older. The study was randomized, double-blind, and active-controlled, and it included both male and female participants.
LAM group is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for chronic Hepatitis B. The drug has completed a Phase 3 trial, but it has not yet received regulatory approval. Further evaluation and regulatory review are required before it can be made available to patients.