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Research History | PU Koreana | Clinical Studies | GMP

Clinical Studies


PHARMACOLOGY

Destruction of Dane Particle
HBV Dane Particle
Hepaguard® Treated
Visible destruction of viral (Dane) particles in an aqueous extract of Hepaguard® was demonstrated under EM.
Antiviral Effect of Phyllanthus Extract in Woodchuck model of Hepatitis B virus Infection (Efficacy Test)

TOXICOLOGY

Genotoxicology Studies

    Salmonella / Microsome Mutation Assay (AMES Test)

    Mouse Peripheral Blood Micronucleus Assay

    In Vitro Chromosome Aberration Assay in Human Peripheral Lymphocytes

Toxicology Studies

    Acute oral toxicity test of Phyllanthus extract on mice

    Acute toxicity test on mice by intraperitoneal administration for Phyllanthus

    Acute oral toxicity test on beagle dog for Phyllanthus extract

    Chronic toxicology and pharmacology of aqueous extracts of Phyllanthus urinaria in woodchucks

    The 4 week repeated dose toxicity study (oral) in rats – Phyllanthus Urinaria Extracts

PHASE II CLINICAL TRIAL

Randomized, Controlled, Phase II Clinical Trials of Hepaguard®
for the evaluation of Efficacy and Safety with Chronic Hepatitis B Patients

Trial Duration: 12 months

Trial Size: 30

During the course of treatment:

28 patients: HBV-DNA (+) > HBV-DNA (-)

7 patients: HBeAg (+) > HBeAg (-) &

Anti-HBeAb (-) > Anti-HBeAb (+)

PHASE III CLINICAL TRIAL

Randomized, Multicenter, Double-blind, Double-dummy, Placebo-controlled Study of Hepaguard® in Patients with Chronic Hepatitis B Infection

Trial Duration:
9 months + 1 month follow-up

Trial Size:
Treatment Group - 80 patients
Comparative Group - 40 patients

Trial Completion:
May, 2002

OTC Drug License Granted:
April, 2003 (by Korea FDA)

PHASE II / III CLINICAL TRIAL

Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled Study of Hepaguard® in Patients with Chronic Hepatitis B Infection

Trial Duration: 9 months treatment + 6 months follow-up

Trial Size: 280 patients

Trial Approval Granted:
April, 2003 (by Department of Health of Taiwan, ROC)

Proliferating Process of HBV in the Hepatocyte
                                &
                    sites of Hepaguard Effect