NCT03625102

A Randomized, Double-Blind Trial of Antroquinonol in Patients With Chronic Hepatitis B

A Randomized, Double-Blind, Dosing-Ranging, Placebo-controlled Trial of Antroquinonol in Patients With Chronic Hepatitis B

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Golden Biotechnology Corporation · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Hepatitis B virus infection is a worldwide disease and is still the most common cause of hepatocellular carcinoma (HCC).Existing treatments for hepatitis B infection have various side-effects including renal toxicity and drug resistance or failure.

Detailed description

Hepatitis B virus infection is a worldwide disease and is still the most common cause of hepatocellular carcinoma (HCC). Those carriers in China account for 33% of all chronic carriers globally. A big epidemiological study of patients with chronic hepatitis B has revealed that baseline HBV DNA level or cirrhosis is an independent predictor for the occurrence of HCC. Antroquinonol is a new chemical entity isolated from the mycelium of Antrodia camphorata, which showed interesting anticancer and anti-inflammatory activities.Previous studies have indicated that signaling molecules, such as PI3K, AMPK, and mTOR, participate in Antroquinonol-induced cancer cell death, whereas Nrf2 and NF-kB are involved in the anti-inflammatory effects of Antroquinonol. Moreover, we also found the administration of Antroquinonol also differentially modulated T cell activity and reduced IL-18 production, but enhanced the activation of Nrf2 and, thus, suppressed oxidative stress by animal studies. These results demonstrate the potential applications of Antroquinonol in treating hepatitis B.

Conditions

• HBV

Interventions

Type	Name	Description
DRUG	Antroquinonol	Antroquinonol will be provided as a capsule-shaped which contain 50 mg Antroquinonol.
OTHER	placebo	The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects

Timeline

• Start date: 2018-08-01
• Primary completion: 2023-06-16
• Completion: 2023-06-16
• First posted: 2018-08-10
• Last updated: 2023-09-13

Locations

1 site across 1 country: Taiwan