- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00556504
The Effects of Adding TCM-700C on the Standard Combination Treatment for Patients With Genotype 1 Hepatitis C Infection (TCM-700C)
TCM-700C Phase II Trial The Effects of Adding a Chinese Formulation (TCM-700C) on the Standard Combination Treatment for Patients With Genotype 1 Hepatitis C Infection
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This was a randomized, double-blind, placebo controlled, parallel-group, Phase 2 study to evaluate the effects of adding a Chinese formulation (TCM-700C) on the standard combination treatment for patients with Genotype 1 hepatitis C infection. Patients were screened within 4 weeks before receive the first study drug dose. Eligible patients at baseline were stratified according to baseline HCV RNA (≤800,000 IU/ml vs >800,000 IU/ml) and randomized with an equal chance to receive either TCM-700C or placebo as an add-on to the combination drug therapy. The combination drug therapy was peginterferon α-2b (PEG-INTRON®, Schering-Plough) 1.5 micrograms/kg once weekly injection for 48 weeks plus oral ribavirin (REBETOL®, Shering-Plough) 1000mg-1200mg daily for 48 weeks. The add-on treatment of TCM-700C or placebo was given 2 tablets thrice daily for 48 weeks.
During the 48 week treatment period and 24 week untreated follow-up, patients were assessed at regular intervals for safety and efficacy at weeks 2, 4, 8, 12, 16 and then every 8 weeks thereafter until study completion. Patients who prematurely discontinued test drug therapy had laboratory examination re-taken on the week patient was discontinued from study.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Taoyuan, Taiwan, 333
- Chang Gung memorial hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- HCV strain confirmed as genotype I;
- Elevated ALT (≥1.5 x upper limit of normal)during last 6 months
- Females of childbearing potential with a negative serum pregnancy test
- Subject must be willing to sign a written informed consent
- Subject must be willing and able to adhere to dose and visit schedule.
Exclusion Criteria:
- Serum AFP levels > 400 ng/ml
- Liver biopsy within 12 months prior to study entry showed liver cirrhosis with METAVIR system fibrosis score of 3-4, or hepatocellular carcinoma (HCC);
- Co-infection with hepatitis B virus (HBV);
- Anti-HIV positive;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TCM-700C
an add-on drug (2 tablets/t.i.d) to conventional treatment(Peginterferon alfa-2a + ribavirin) of Hepatitis C
|
An add-on drug to conventional treatment of Hepatitis C
conventional treatment of Hepatitis C
Other Names:
conventional treatment of Hepatitis C
Other Names:
|
Placebo Comparator: Placebo
placebo add on(2 tablets/t.i.d) to conventional treatment(Peginterferon alfa-2a + ribavirin) of Hepatitis C
|
conventional treatment of Hepatitis C
Other Names:
conventional treatment of Hepatitis C
Other Names:
Placebo, without acting ingredient.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sustained Virologic Response (SVR)
Time Frame: 24 weeks after the termination of combinational drug treatment (up to 72 weeks)
|
SVR is defined as no detectable HCV RNA in serum of patient at Week 72, which is 24 weeks after the termination of combination drug treatment..
Serum HCV RNA will be tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit) |
24 weeks after the termination of combinational drug treatment (up to 72 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Virologic Response
Time Frame: at the end of combination drug treatment (up to 48 weeks)
|
undetectable HCV RNA at the end of combination drug treatment Serum HCV RNA will be tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit). |
at the end of combination drug treatment (up to 48 weeks)
|
ALT Response
Time Frame: at the end of combination drug treatment (up to 48 weeks)
|
An ALT response is defined as normalization of ALT at the end of combination drug treatment. (ALT normalization is defined as ALT level decreases into within the normal range) |
at the end of combination drug treatment (up to 48 weeks)
|
Sustained ALT Response
Time Frame: 24 weeks after the termination of combinational drug treatment (up to 72 weeks)
|
a sustained ALT response is defined as sustained normalization of ALT 24 weeks after cessation of combination drug treatment.
|
24 weeks after the termination of combinational drug treatment (up to 72 weeks)
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Combined ALT and Virologic Response
Time Frame: at the end of combination drug treatment (up to 48 weeks)
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Combined ALT and virologic response at the end of combination drug treatment.
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at the end of combination drug treatment (up to 48 weeks)
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Immune Cell Normalization
Time Frame: at the end of combination drug treatment (up to 48 weeks)
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Normalization of immune cells, CD4, CD8 and NK cells at the end of combination drug treatment (Immune cell normalization is defined as return of CD4, CD8 and NK cells to normal range) |
at the end of combination drug treatment (up to 48 weeks)
|
Immune Cell Normalization
Time Frame: 24 weeks after the termination of combinational drug treatment (up to 72 weeks)
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Normalization of immune cells, CD4, CD8 and NK cells at 24 weeks after cessation of combination drug treatment.
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24 weeks after the termination of combinational drug treatment (up to 72 weeks)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: I-Sheen Sheen, MD, Chang Gung memorial hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis C, Chronic
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Ribavirin
- Peginterferon alfa-2a
- Peginterferon alfa-2b
Other Study ID Numbers
- TCM-700-01-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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