The Effects of Adding TCM-700C on the Standard Combination Treatment for HCV Genotype 1 Patients(Phase III)
Primary Purpose
Chronic Hepatitis C
Status
Withdrawn
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Peginterferon alfa-2a
Ribavirin
TCM-700C
Placebo
Sponsored by

About this trial
This is an interventional treatment trial for Chronic Hepatitis C focused on measuring add-on treatment, botanical drug, HCV genotype 1, TCM-700C
Eligibility 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:
- 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.
Sites / Locations
- Peking University People's Hospit
- Chang Gung Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
TCM-700C (low dose)
TCM-700C (high dose)
Placebo
Arm Description
an add-on drug (t.i.d) to conventional treatment(Peginterferon alfa-2a + ribavirin) of Hepatitis C
an add-on drug (t.i.d) to conventional treatment(Peginterferon alfa-2a + ribavirin) of Hepatitis C
placebo add on(t.i.d) to conventional treatment(Peginterferon alfa-2a + ribavirin) of Hepatitis C
Outcomes
Primary Outcome Measures
sustained virologic response (SVR) rate
undetectable HCV RNA 24 weeks after the EOT.
Secondary Outcome Measures
Virologic response (VR)
undetectable HCV RNA at the EOT.
relapse rate
undetectable HCV RNA at the EOT followed by a positive HCV RNA level within 24 weeks after the EOT
Full Information
NCT ID
NCT01890200
First Posted
June 26, 2013
Last Updated
April 26, 2017
Sponsor
TCM Biotech International Corp.
1. Study Identification
Unique Protocol Identification Number
NCT01890200
Brief Title
The Effects of Adding TCM-700C on the Standard Combination Treatment for HCV Genotype 1 Patients(Phase III)
Official Title
A Phase III, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Effects of Adding TCM-700C,Botanical Drug, on the Standard Treatment (Peginterferon and Ribavirin) for Subjects With Naive Genotype 1 Hepatitis C Infection
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Withdrawn
Study Start Date
June 2015 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TCM Biotech International Corp.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
add-on treatment, botanical drug, HCV genotype 1, TCM-700C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TCM-700C (low dose)
Arm Type
Experimental
Arm Description
an add-on drug (t.i.d) to conventional treatment(Peginterferon alfa-2a + ribavirin) of Hepatitis C
Arm Title
TCM-700C (high dose)
Arm Type
Experimental
Arm Description
an add-on drug (t.i.d) to conventional treatment(Peginterferon alfa-2a + ribavirin) of Hepatitis C
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo add on(t.i.d) to conventional treatment(Peginterferon alfa-2a + ribavirin) of Hepatitis C
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa-2a
Other Intervention Name(s)
Pegasys
Intervention Description
conventional treatment of Hepatitis C
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Rebetol
Intervention Description
conventional treatment of Hepatitis C
Intervention Type
Drug
Intervention Name(s)
TCM-700C
Intervention Description
An add-on drug to conventional treatment of Hepatitis C
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo, without acting ingredient.
Intervention Description
Placebo, without acting ingredient.
Primary Outcome Measure Information:
Title
sustained virologic response (SVR) rate
Description
undetectable HCV RNA 24 weeks after the EOT.
Time Frame
24 weeks after the end of treatment (EOT, 48 weeks)
Secondary Outcome Measure Information:
Title
Virologic response (VR)
Description
undetectable HCV RNA at the EOT.
Time Frame
at the EOT (48 weeks)
Title
relapse rate
Description
undetectable HCV RNA at the EOT followed by a positive HCV RNA level within 24 weeks after the EOT
Time Frame
24 weeks after the EOT
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
I-Shyan Sheen, MD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lai Wei, MD
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University People's Hospit
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effects of Adding TCM-700C on the Standard Combination Treatment for HCV Genotype 1 Patients(Phase III)
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