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The Effects of Adding TCM-700C on the Standard Combination Treatment for Patients With Genotype 1 Hepatitis C Infection (TCM-700C)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00556504
First Posted: November 12, 2007
Last Update Posted: August 7, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
TCM Biotech International Corp.
Results First Submitted: June 5, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Hepatitis C
Interventions: Drug: TCM-700C
Drug: Peginterferon alfa-2a
Drug: Ribavirin
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
recruitment period: 12 Months location: CGMH clinical ceters

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
TCM-700C

TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C

TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.

Placebo

Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C

Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.


Participant Flow:   Overall Study
    TCM-700C   Placebo
STARTED   42   42 
Intend-to Treat Population   42   42 
Safety Population   41   42 
COMPLETED   34   33 
NOT COMPLETED   8   9 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
TCM-700C TCM-700C, an add-on drug to conventional treatment of Hepatitis C
Placebo Placebo with convetional treatment for HCV patients
Total Total of all reporting groups

Baseline Measures
   TCM-700C   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 42   42   84 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   42   42   84 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.6  (9.58)   48.74  (11.52)   48.67  (10.53) 
Gender 
[Units: Participants]
     
Female   22   15   37 
Male   20   27   47 
Region of Enrollment 
[Units: Participants]
     
Taiwan   42   42   84 
Fibrosis score [1] 
[Units: Participants]
     
Fibrosis score 0   0   2   2 
Fibrosis score 1   11   21   32 
Fibrosis score 2   31   19   50 
[1]

Liver biopsy within 12 months prior to study entry showed liver cirrhosis with METAVIR system fibrosis score

0 No fibrosis

  1. Stellate enlargement of portal tract but without septa formation
  2. Enlargement of portal tract with rare septa formation


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Sustained Virologic Response (SVR)   [ Time Frame: 24 weeks after the termination of combinational drug treatment (up to 72 weeks) ]

2.  Secondary:   Virologic Response   [ Time Frame: at the end of combination drug treatment (up to 48 weeks) ]

3.  Secondary:   ALT Response   [ Time Frame: at the end of combination drug treatment (up to 48 weeks) ]

4.  Secondary:   Sustained ALT Response   [ Time Frame: 24 weeks after the termination of combinational drug treatment (up to 72 weeks) ]

5.  Secondary:   Combined ALT and Virologic Response   [ Time Frame: at the end of combination drug treatment (up to 48 weeks) ]

6.  Secondary:   Immune Cell Normalization   [ Time Frame: at the end of combination drug treatment (up to 48 weeks) ]

7.  Secondary:   Immune Cell Normalization   [ Time Frame: 24 weeks after the termination of combinational drug treatment (up to 72 weeks) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Ya-Chun Wang, EVP/CSO
Organization: TCM Biotech International
phone: 886-2-26581677 ext 733
e-mail: yachunwang@tcmbio.com



Responsible Party: TCM Biotech International Corp.
ClinicalTrials.gov Identifier: NCT00556504     History of Changes
Other Study ID Numbers: TCM-700-01-04
First Submitted: November 8, 2007
First Posted: November 12, 2007
Results First Submitted: June 5, 2013
Results First Posted: July 8, 2014
Last Update Posted: August 7, 2014