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Placebo & Entecavir
Entecavir inhibits hepatitis B virus reverse transcriptase and protein priming, reducing viral replication in chronic hepatitis B infection.
Entecavir inhibits hepatitis B virus reverse transcriptase and protein priming, reducing viral replication in chronic hepatitis B infection. Used for Chronic hepatitis B infection.
At a glance
| Generic name | Placebo & Entecavir |
|---|---|
| Also known as | Standard Therapy, baraclude |
| Sponsor | Fu-Sheng Wang |
| Drug class | Nucleoside reverse transcriptase inhibitor (NRTI) |
| Target | Hepatitis B virus reverse transcriptase / HBV polymerase |
| Modality | Small molecule |
| Therapeutic area | Virology / Hepatology |
| Phase | FDA-approved |
Mechanism of action
Entecavir is a nucleoside analog that selectively inhibits HBV polymerase, blocking both reverse transcription and protein priming steps essential for viral DNA synthesis. It achieves high potency against HBV with minimal activity against human reverse transcriptases, making it selective for the viral enzyme. The placebo component in this formulation indicates a comparative study design.
Approved indications
- Chronic hepatitis B infection
Common side effects
- Headache
- Fatigue
- Diarrhea
- Nausea
- Lactic acidosis (rare)
Key clinical trials
- A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection (PHASE1)
- A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) Infection (PHASE2)
- A Multicenter Study to Determine the Depth and Duration of Hepatitis B Surface Antigen (HBsAg) Reduction After Single or Multiple Doses of ARC-520, in Combination With Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection (PHASE2)
- A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Positive, Chronic Hepatitis B Virus Infection (PHASE2)
- A Study of ARC-521 Injection in Normal Adult Volunteers and Patients With Chronic Hepatitis B (CHB) (PHASE1)
- A Study of ALG-000184 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects (PHASE1)
- Study of ARC-520 in Participants With Hepatitis B Virus e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (PHASE2)
- A Phase III Study to Evaluate the Efficacy and Safety of ZM-H1505R in Patients With CHB (PHASE3)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |