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| Sponsored by: |
TCM Biotech International Corp. |
| Information provided by: | TCM Biotech International Corp. |
| ClinicalTrials.gov Identifier: | NCT00556504 |
Purpose
The primary objective of this study is to evaluate the effectiveness of TCM-700C as an add-on treatment to the combination drug therapy (Peginterferon α-2b plus Ribavirin) for patients with genotype 1 chronic hepatitis C infections. 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 combinational drug treatment, compared with the placebo add-on.
| Condition | Intervention | Phase |
|
Chronic Hepatitis C |
Drug: TCM-700C Drug: Placebo |
Phase II |
| MedlinePlus related topics: | Hepatitis Hepatitis C |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | 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 |
| Estimated Enrollment: | 80 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | November 2010 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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1: Experimental
TCM-700C
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Drug: TCM-700C
2 tablets thrice daily from the beginning and for a total of 48 weeks
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2: Placebo Comparator
Placebo
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Drug: Placebo
2 tablets thrice daily from the beginning and for a total of 48 weeks
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Eligibility
| Ages Eligible for Study: | 20 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Crystal Wang | 886-2-2657-7777 ext 663 | crystal.wang@ppccro.com |
| Taiwan | |||||
| Chang Gung Memorial Hospital | Recruiting | ||||
| Taoyuan, Taiwan, 333 | |||||
| Contact: I-Sheen Sheen, MD 886-968-372-340 issheen.jks@gmail.com | |||||
| TCM Biotech International Corp. |
| Principal Investigator: | I-Sheen Sheen, MD | Chang Gung Memorial Hospital |
More Information
| Responsible Party: | TCM Biotech International Corp. ( TCM Biotech International Corp. ) |
| Study ID Numbers: | TCM-700-01-04, 96-EC-17-A-20-I1-0017 |
| First Received: | November 8, 2007 |
| Last Updated: | December 25, 2007 |
| ClinicalTrials.gov Identifier: | NCT00556504 |
| Health Authority: | United States: Food and Drug Administration; Taiwan (R.O.C.): Department of Health |
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