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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)

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ClinicalTrials.gov Identifier: NCT00556504
Recruitment Status : Completed
First Posted : November 12, 2007
Results First Posted : July 8, 2014
Last Update Posted : August 7, 2014
Sponsor:
Information provided by (Responsible Party):
TCM Biotech International Corp.

Tracking Information
First Submitted Date  ICMJE November 8, 2007
First Posted Date  ICMJE November 12, 2007
Results First Submitted Date  ICMJE June 5, 2013
Results First Posted Date  ICMJE July 8, 2014
Last Update Posted Date August 7, 2014
Study Start Date  ICMJE July 2007
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2014)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: November 9, 2007)
Sustained Virologic Response (SVR) [ Time Frame: the absence of detectable HCV RNA 24 weeks after the termination of combinational drug treatment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2014)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2007)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Adding TCM-700C on the Standard Combination Treatment for Patients With Genotype 1 Hepatitis C Infection
Official Title  ICMJE 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
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis C
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 13, 2012)
84
Original Estimated Enrollment  ICMJE
 (submitted: November 9, 2007)
80
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00556504
Other Study ID Numbers  ICMJE TCM-700-01-04
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party TCM Biotech International Corp.
Study Sponsor  ICMJE TCM Biotech International Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: I-Sheen Sheen, MD Chang Gung Memorial Hospital
PRS Account TCM Biotech International Corp.
Verification Date July 2014

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