The Effects of Adding TCM-700C on the Standard Combination Treatment for HCV Genotype 1 Patients(Phase III)

NCT01890200 | Withdrawn Phase 3

• 1 other identifier: TCM-700-02-01
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 2

Brief Summary

This is a randomized, double blind, multi-center, placebo controlled, three parallel arms, Phase IIb/III clinical study to evaluate the effects of adding a TCM-700C with a low or high dose onto the combination treatment (PegIFN plus RBV) for subjects with naive genotype 1 HCV infection. 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 combination treatment, compared with the placebo add-on.

Conditions

Chronic Hepatitis C

Keywords

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

Outcome Measures

Primary Outcomes (1)

• sustained virologic response (SVR) rate

  undetectable HCV RNA 24 weeks after the EOT.

  24 weeks after the end of treatment (EOT, 48 weeks)

Secondary Outcomes (2)

• Virologic response (VR)

  at the EOT (48 weeks)

• relapse rate

  24 weeks after the EOT

Study Arms (3)

TCM-700C (low dose)

EXPERIMENTAL

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

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

TCM-700C (high dose)

EXPERIMENTAL

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

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

Placebo

PLACEBO COMPARATOR

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

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

Interventions

Peginterferon alfa-2a DRUG

conventional treatment of Hepatitis C

Also known as: Pegasys

Placebo; TCM-700C (high dose); TCM-700C (low dose)

Ribavirin DRUG

conventional treatment of Hepatitis C

Also known as: Rebetol

Placebo; TCM-700C (high dose); TCM-700C (low dose)

TCM-700C DRUG

An add-on drug to conventional treatment of Hepatitis C

TCM-700C (high dose); TCM-700C (low dose)

Placebo DRUG

Placebo, without acting ingredient.

Also known as: 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:

• Adult subjects who are 20 to 65 years old (inclusive), of either gender and in any ethnical group in Asia.
• Chronic hepatitis C, positive with both antibody to hepatitis C virus (anti HCV) and HCV RNA assays.
• Confirmed HCV genotype 1.
• Subjects who are indicated to have combination treatment of PegIFNα 2a and RBV at the discretion of the investigator.
• All fertile males and females receiving RBV must be using two forms of effective contraception during treatment with study drugs and 6 months post treatment completion.
• Subjects must voluntarily give written informed consent indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
• Subjects must be able to comply with the assessments during the study.
• Subjects must be able to understand study QoL questionnaires.

You may not qualify if:

• Prior treatment with any IFN α or any medicines that contain Cordyceps.
• Prior treatment of hepatitis C with any other antiviral or immune modulators.
• Investigational therapy administered within 4 weeks, or within a time interval less than at least 5 half lives of the investigational agent, whichever is longer, prior to the first scheduled day of dosing in this study.
• Subjects diagnosed with hepatocellular carcinoma (HCC) by biopsy or α fetoprotein (AFP) serology and radiology (helical computed tomography \[CT\] and/or magnetic resonance imaging \[MRI\]) within 5 years of signing the informed consent form.
• Evidence of hepatic decompensation (history or current evidence of ascites, bleeding varices or hepatic encephalopathy).
• History or evidence of other liver diseases other than chronic HCV infection.
• Subjects with known allergy or hypersensitivity to any ingredient of the study drug or placebo.
• Pregnant, planning on becoming pregnant, or breastfeeding female subject or male subject whose partner is pregnant or planning on becoming pregnant.
• Subject with any of the following laboratory abnormalities:
• Platelet count \<90,000/mm3;
• Absolute neutrophil count \<1500 cells/mm3;
• Hemoglobin \<12 g/dL for women and \<13 g/dL for men;
• Creatinine \>1.5 mg/dL;
• Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>10 x upper limit of normal (ULN);
• Total serum bilirubin \>1.5 x ULN;

Sponsors & Collaborators

• TCM Biotech International Corp.: lead

Study Sites (2)

Peking University People's Hospit

Beijing, Beijing Municipality, 100044, China

Location

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2a; 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

Study Officials

• I-Shyan Sheen, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Lai Wei, MD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: June 26, 2013
• First Posted: July 1, 2013
• Study Start: June 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: June 1, 2018
• Last Updated: April 28, 2017

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1); CN (1)