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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TCM Biotech International Corp.
ClinicalTrials.gov Identifier:
NCT00556504
First received: November 8, 2007
Last updated: August 4, 2014
Last verified: July 2014
  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: Peginterferon alfa-2a
Drug: Ribavirin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by TCM Biotech International Corp.:

Primary Outcome Measures:
  • Sustained Virologic Response (SVR) [ Time Frame: 24 weeks after the termination of combinational drug treatment (up to 72 weeks) ] [ Designated as safety issue: No ]

    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)



Secondary Outcome Measures:
  • Virologic Response [ Time Frame: at the end of combination drug treatment (up to 48 weeks) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]
    Normalization of immune cells, CD4, CD8 and NK cells at 24 weeks after cessation of combination drug treatment.


Enrollment: 84
Study Start Date: July 2007
Study Completion Date: May 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TCM-700C
an add-on drug (2 tablets/t.i.d) to conventional treatment(Peginterferon alfa-2a + ribavirin) of Hepatitis C
Drug: TCM-700C
An add-on drug to conventional treatment of Hepatitis C
Other Name: TCM-700C
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)
Placebo Comparator: Placebo
placebo add on(2 tablets/t.i.d) to conventional treatment(Peginterferon alfa-2a + ribavirin) 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.
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556504

Locations
Taiwan
Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333
Sponsors and Collaborators
TCM Biotech International Corp.
Investigators
Principal Investigator: I-Sheen Sheen, MD Chang Gung Memorial Hospital
  More Information

No publications provided

Responsible Party: TCM Biotech International Corp.
ClinicalTrials.gov Identifier: NCT00556504     History of Changes
Other Study ID Numbers: TCM-700-01-04
Study First Received: November 8, 2007
Results First Received: June 5, 2013
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration
Taiwan : Food and Drug Administration

Keywords provided by TCM Biotech International Corp.:
add-on treatment
botanical drug
HCV genotype 1
TCM-700C
genotype I

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferon-alpha
Peginterferon alfa-2a
Ribavirin
Anti-Infective Agents
Antimetabolites
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014