Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT01289782) enrolled 394 adults with Hepatitis C — 264 in the group receiving the investigational drug TMC435 (150mg) alongside standard antiviral treatment, and 130 in the group receiving a placebo alongside standard antiviral treatment. The trial was measuring whether the Hepatitis C virus became undetectable in participants' blood and stayed undetectable for a period of weeks to months after treatment finished. Of those who started the trial, 239 in the TMC435 group and 118 in the placebo group completed it. The reported data shows that for the main outcome — the proportion of participants whose virus was undetectable 12 weeks after the planned end of treatment — 79.5% of those in the TMC435 group reached this point, compared with 50% in the placebo group. For related measures checked at other time points, the reported figures were broadly similar: at 4 weeks after the end of treatment, 82.2% (TMC435) versus 56.2% (placebo); at 24 weeks after, 79.5% versus 49.2%; and at a later check around week 72, 78.4% versus 49.2%. The reported data also tracked how the level of Hepatitis C virus in participants' blood changed over time, measured on a scientific scale (log10 IU/mL — essentially a way of expressing very large or very small numbers in a compact form). These figures showed reductions in virus levels in both groups across various time points during and after treatment, with the TMC435 group generally showing larger reductions at the earlier time points during active treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 25445400) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Hepatitis C Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been confirmed to have a specific type of hepatitis C called "genotype 1" (checked at a screening appointment)
- You have never received any treatment for hepatitis C before
- You have had a liver biopsy (a small sample taken from your liver) within the last 3 years, or are willing to have one before the study begins, showing ongoing hepatitis C infection
- You are willing to use 2 forms of reliable contraception (birth control) throughout the entire study, whether you are male or female
Who may not be able to join:
- You have HIV, or a type of hepatitis C other than genotype 1
- You have liver disease that is caused by something other than hepatitis C
- Your liver is not functioning properly due to serious liver damage (confirm with trial site)
- You have significantly abnormal blood test results or other serious active health conditions
- You are pregnant or planning to become pregnant during the study
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Janssen R&D Ireland Clinical Trial, Janssen R&D Ireland
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
6 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.