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

• Status: Withdrawn
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TCM Biotech International Corp.
• Treatments: Interferon-alpha; Peginterferon alfa-2a; Ribavirin

Criteria

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.