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

NCT00556504 | Completed Phase 2 Results

• 1 other identifier: TCM-700-01-04
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis C

Keywords

add-on treatment; botanical drug; HCV genotype 1; TCM-700C; genotype I

Outcome Measures

Primary Outcomes (1)

• Sustained Virologic Response (SVR)

  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)

  24 weeks after the termination of combinational drug treatment (up to 72 weeks)

Secondary Outcomes (6)

• Virologic Response

  at the end of combination drug treatment (up to 48 weeks)

• ALT Response

  at the end of combination drug treatment (up to 48 weeks)

• Sustained ALT Response

  24 weeks after the termination of combinational drug treatment (up to 72 weeks)

• Combined ALT and Virologic Response

  at the end of combination drug treatment (up to 48 weeks)

• Immune Cell Normalization

  at the end of combination drug treatment (up to 48 weeks)

Study Arms (2)

TCM-700C

EXPERIMENTAL

an add-on drug (2 tablets/t.i.d) to conventional treatment(Peginterferon alfa-2a + ribavirin) of Hepatitis C

Drug: TCM-700C; Drug: Peginterferon alfa-2a; Drug: Ribavirin

Placebo

PLACEBO COMPARATOR

placebo add on(2 tablets/t.i.d) to conventional treatment(Peginterferon alfa-2a + ribavirin) of Hepatitis C

Drug: Peginterferon alfa-2a; Drug: Ribavirin; Drug: Placebo

Interventions

TCM-700C DRUG

An add-on drug to conventional treatment of Hepatitis C

TCM-700C

Peginterferon alfa-2a DRUG

conventional treatment of Hepatitis C

Also known as: Peg-INTRON, Schering-Plough

Placebo; TCM-700C

Ribavirin DRUG

conventional treatment of Hepatitis C

Also known as: Rebetol, Schering-Plough)

Placebo; TCM-700C

Placebo DRUG

Placebo, without acting ingredient.

Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• TCM Biotech International Corp.: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Taiwan, 333, Taiwan

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2a; peginterferon alfa-2b; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Dr. Ya-Chun Wang, EVP/CSO
• Organization: TCM Biotech International

yachunwang@tcmbio.com

886-2-26581677

Study Officials

• I-Sheen Sheen, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2007
• First Posted: November 12, 2007
• Study Start: July 1, 2007
• Primary Completion: January 1, 2011
• Study Completion: May 1, 2011
• Last Updated: August 7, 2014
• Results First Posted: July 8, 2014

Record last verified: 2014-07

Locations

TW (1)