Phase 2
N=84
The Effects of Adding TCM-700C on the Standard Combination Treatment for Patients With Genotype 1 Hepatitis C Infection
Chronic Hepatitis C
Bottom Line
View on ClinicalTrials.gov: NCT00556504 ↗Enrolled (actual)
84
Serious AEs
18.1%
Results posted
Jul 2014
Primary outcome: Primary: Sustained Virologic Response (SVR) — 27; 29 Number of participants with SVR
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TCM-700C (Drug); Peginterferon alfa-2a (Drug); Ribavirin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- TCM Biotech International Corp.
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sustained Virologic Response (SVR) |
27; 29 | — |
| SECONDARY Virologic Response |
34; 31 | — |
| SECONDARY ALT Response |
32; 30 | — |
| SECONDARY Sustained ALT Response |
26; 27 | — |
| SECONDARY Combined ALT and Virologic Response |
31; 29 | — |
| SECONDARY Immune Cell Normalization |
30; 25; 34; 30; 36; 31 | — |
| SECONDARY Immune Cell Normalization |
30; 25; 34; 30; 36; 31 | — |
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.
Eligibility 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;
Data sourced from ClinicalTrials.gov (NCT00556504). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.