The Effects of Adding TCM-700C on the Standard Combination Treatment for HCV Genotype 1 Patients(Phase III)
The Effects of Adding TCM-700C on the Standard Combination Treatment for HCV Genotype 1 Patients(Phase III)
This is a randomized, double blind, multi-center, placebo controlled, three parallel arms,
 Phase IIb/III clinical study to evaluate the effects of adding a TCM-700C with a low or high
 dose onto the combination treatment (PegIFN plus RBV) for subjects with naive genotype 1 HCV
 infection.

 This will be demonstrated by a higher sustained virologic response rate, defined as the
 absence of detectable HCV RNA 24 weeks after the termination of combination treatment,
 compared with the placebo add-on.
Eligible subjects with written informed consent will be stratified according to their
 baseline HCV RNA (≤800,000 IU/mL versus>800,000 IU/mL), stage of liver fibrosis (METAVIR
 system fibrosis score of 0 1 versus 2 3).

 During the 48 week Treatment Period and 24 week Follow up Period, subjects will be assessed
 at regular intervals for efficacy and safety at Weeks 2, 4, 8, 12, 16 and then every 8 weeks
 thereafter until study completion. If possible, subjects who prematurely discontinue the
 study during the Treatment Period will have samples taken for hematology, biochemistry and
 urinalysis in the same week of discontinuation as well as 24 weeks after discontinuation.
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.