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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.
November 8, 2007
November 12, 2007
June 5, 2013
July 8, 2014
August 7, 2014
July 2007
January 2011   (Final data collection date for primary outcome measure)
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..

  1. A subject is a sustained responder at a given week, if the subject has negative HCV RNA at that week and all the subsequent weeks through Week 72.
  2. If a patient has a missing value between visits, then the last non-missing HCV RNA is carried forward to fill in the missing value.
  3. If the patient's HCV RNA at last visit, Week 72 is missing or above the limit of detection, then the patient is a non-responder, even if all the previous visits from baseline onwards were undetectable.

Serum HCV RNA will be tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit)

Sustained Virologic Response (SVR) [ Time Frame: the absence of detectable HCV RNA 24 weeks after the termination of combinational drug treatment ]
Complete list of historical versions of study NCT00556504 on ClinicalTrials.gov Archive Site
  • 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).

  • 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)

  • 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.
  • Combined ALT and Virologic Response [ Time Frame: at the end of combination drug treatment (up to 48 weeks) ]
    Combined ALT and virologic response at the end of combination drug treatment.
  • Immune Cell Normalization [ Time Frame: at the end of combination drug treatment (up to 48 weeks) ]

    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)

  • Immune Cell Normalization [ Time Frame: 24 weeks after the termination of combinational drug treatment (up to 72 weeks) ]
    Normalization of immune cells, CD4, CD8 and NK cells at 24 weeks after cessation of combination drug treatment.
Virologic response Alanine amino transferase (ALT) response Normalization of immune cells Relapse rate Safety [ Time Frame: the absence of detectable HCV RNA 24 weeks after the termination of combinational drug treatment ]
Not Provided
Not Provided
 
The Effects of Adding TCM-700C on the Standard Combination Treatment for Patients With Genotype 1 Hepatitis C Infection
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
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Hepatitis C
  • Drug: TCM-700C
    An add-on drug to conventional treatment of Hepatitis C
  • Drug: Peginterferon alfa-2a
    conventional treatment of Hepatitis C
    Other Name: Peg-INTRON, Schering-Plough
  • Drug: Ribavirin
    conventional treatment of Hepatitis C
    Other Name: Rebetol, Schering-Plough)
  • Drug: Placebo
    Placebo, without acting ingredient.
  • Experimental: TCM-700C
    an add-on drug (2 tablets/t.i.d) to conventional treatment(Peginterferon alfa-2a + ribavirin) of Hepatitis C
    Interventions:
    • Drug: TCM-700C
    • Drug: Peginterferon alfa-2a
    • Drug: Ribavirin
  • Placebo Comparator: Placebo
    placebo add on(2 tablets/t.i.d) to conventional treatment(Peginterferon alfa-2a + ribavirin) of Hepatitis C
    Interventions:
    • Drug: Peginterferon alfa-2a
    • Drug: Ribavirin
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
May 2011
January 2011   (Final data collection date for primary outcome measure)

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;
Sexes Eligible for Study: All
20 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT00556504
TCM-700-01-04
No
Not Provided
Not Provided
TCM Biotech International Corp.
TCM Biotech International Corp.
Not Provided
Principal Investigator: I-Sheen Sheen, MD Chang Gung Memorial Hospital
TCM Biotech International Corp.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP