Safety and Efficacy Study in Hepatitis C Patients With PHN121

• Status: Terminated
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety, tolerability and efficacy of escalating dose of PHN121 when administered orally in non-responder hepatitis C genotype 1 patients

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PhytoHealth Corporation

Criteria

Inclusion Criteria:

• Nonsmoking adult subjects age 20 years or above, male or female

• Non-Responder HCV patient who failed to achieve sustained viral response (SVR), either do not respond or relapse, to prior 24-week interferon based therapy

• Any antiviral agent discontinued at least 4 weeks before the screening visit.

• Presence of anti-HCV in serum

• Serum and PCR positive for HCV-RNA*1 (Genotype 1)

• Elevated ALT (> 1.3 x upper limit of normal) during last 6 months and (1.3 x to 10 x upper limit of normal) during the screening phase

• No evidence showing liver cirrhosis or hepatocellular carcinoma*2

• Hematological, biochemical and serologic criteria at the screening phase is within normal limits (WNL):

• Hemoglobin values of > 12gm/dl for females and > 13gm/dl for males

• WBC > 3,000/mm3

• Neutrophil > 1,500/mm3

• Platelets count > 90,000/mm3

• Normal PT (INR< 1.2)

• Total bilirubin < 2 mg/dl

• Albumin, WNL

• Serum creatinine, WNL

• Written informed consent

Exclusion Criteria:

• Has evidence of significant renal, cardiovascular, hematopoetic, neurological, pulmonary or gastrointestinal pathology, or any other medical reason or disease that might interfere with the study objectives, as determined by the investigator

• Has participated in other investigational trials within 28 days prior to study enrollment

• Has taken botanical medications*3 within 28 days prior to study enrollment

• Has an surgery within 28 days prior to study enrollment

• Has been diagnosed with any other cause for the liver disease other than chronic hepatitis C including the following conditions:

• Co-infection with HBV

• Hemochromatosis

• Alpha-1 antitrypsin deficiency

• Wilson's disease

• Autoimmune hepatitis

• Alcoholic liver disease

• Drug-related liver disease

• Other liver disease that was considered by the principal investigator

• Has been test positive for HIV

• Has been diagnosed with poor-controlled Diabetes Mellitus (HbA1C > 9.0%)

• Active alcohol abuse of daily intake > 30 g for male and > 20 g for female within the previous 1 year

• Active substance abuse, such as inhaled or injection drugs within the previous 1 year *4

• Female subjects of child bearing potential who are pregnant, nursing, do not agree to practice effective birth control during the time period from 14 days before administration of study drug to 28 days after administration of study drug