The Effects of Adding TCM-700C on the Standard Combination Treatment for HCV Genotype 1 Patients(Phase III)

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring add-on treatment, botanical drug, HCV genotype 1, TCM-700C Read More

Inclusion Criteria:

• Adult subjects who are 20 to 65 years old (inclusive), of either gender and in any ethnical group in Asia.
• Chronic hepatitis C, positive with both antibody to hepatitis C virus (anti HCV) and HCV RNA assays.
• Confirmed HCV genotype 1.
• Subjects who are indicated to have combination treatment of PegIFNα 2a and RBV at the discretion of the investigator.
• All fertile males and females receiving RBV must be using two forms of effective contraception during treatment with study drugs and 6 months post treatment completion.
• Subjects must voluntarily give written informed consent indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
• Subjects must be able to comply with the assessments during the study.
• Subjects must be able to understand study QoL questionnaires.

Exclusion Criteria:

• Prior treatment with any IFN α or any medicines that contain Cordyceps.
• Prior treatment of hepatitis C with any other antiviral or immune modulators.
• Investigational therapy administered within 4 weeks, or within a time interval less than at least 5 half lives of the investigational agent, whichever is longer, prior to the first scheduled day of dosing in this study.
• Subjects diagnosed with hepatocellular carcinoma (HCC) by biopsy or α fetoprotein (AFP) serology and radiology (helical computed tomography [CT] and/or magnetic resonance imaging [MRI]) within 5 years of signing the informed consent form.
• Evidence of hepatic decompensation (history or current evidence of ascites, bleeding varices or hepatic encephalopathy).
• History or evidence of other liver diseases other than chronic HCV infection.
• Subjects with known allergy or hypersensitivity to any ingredient of the study drug or placebo.
• Pregnant, planning on becoming pregnant, or breastfeeding female subject or male subject whose partner is pregnant or planning on becoming pregnant.

• Subject with any of the following laboratory abnormalities:

  1. Platelet count <90,000/mm3;
  2. Absolute neutrophil count <1500 cells/mm3;
  3. Hemoglobin <12 g/dL for women and <13 g/dL for men;
  4. Creatinine >1.5 mg/dL;
  5. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >10 x upper limit of normal (ULN);
  6. Total serum bilirubin >1.5 x ULN;
  7. Subjects without cirrhosis and AFP >50 ng/mL must have an ultrasound between the screening and baseline visit with no findings suspicious for HCC.

• Medical conditions which are contraindications for PegIFNα 2a or RBV therapy:

  1. Psychiatric disorders;
  2. Organ transplant (other than cornea or hair transplant or skin graft);
  3. Severe concurrent medical disease such as severe hypertension, significant coronary heart disease, poorly controlled diabetes mellitus (glycated hemoglobin A1c [HbA1c] >8.5%), not adequately controlled thyroid dysfunction, chronic obstructive pulmonary disease, severe infections (bacterial, viral, fungal, including acute tuberculosis), or hemoglobinopathies (thalassemia major or sickle cell anemia);
  4. Autoimmune hepatitis or other autoimmune conditions known to be exacerbated by PegIFNα 2a and RBV.
• History of a severe seizure disorder or current anticonvulsant use.
• Evidence of severe retinopathy (e.g., cytomegalovirus retinitis, macular degeneration) or clinically relevant ophthalmological disorder (e.g., due to diabetes mellitus or hypertension).
• Other cases judged by the investigator to be ineligible for participation in the study.