Status:
WITHDRAWN
The Effects of Adding TCM-700C on the Standard Combination Treatment for HCV Genotype 1 Patients(Phase III)
Lead Sponsor:
TCM Biotech International Corp.
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
20-65 years
Phase:
PHASE3
Brief 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 co...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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:
- Platelet count \<90,000/mm3;
- Absolute neutrophil count \<1500 cells/mm3;
- Hemoglobin \<12 g/dL for women and \<13 g/dL for men;
- Creatinine \>1.5 mg/dL;
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>10 x upper limit of normal (ULN);
- Total serum bilirubin \>1.5 x ULN;
- 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:
- Psychiatric disorders;
- Organ transplant (other than cornea or hair transplant or skin graft);
- 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);
- 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.
Key Trial Info
Start Date :
June 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01890200
Start Date
June 1 2015
End Date
June 1 2018
Last Update
April 28 2017
Active Locations (2)
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1
Peking University People's Hospit
Beijing, Beijing Municipality, China, 100044
2
Chang Gung Memorial Hospital
Taoyuan District, Taiwan, 333