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 enrolled 386 adults with Hepatitis C across five treatment groups. Participants received either the investigational drug TMC435 (at one of two doses — 75 mg or 150 mg — and for either 12 or 24 weeks) combined with a standard backbone treatment called PR (pegylated interferon and ribavirin), or a placebo combined with the same PR treatment. The main thing the trial was measuring was whether participants had no detectable Hepatitis C virus in their blood at the end of treatment and again at 72 weeks (roughly 18 months) after the study began — a result researchers called a "sustained virologic response." The reported data shows that, for the primary goal (no detectable virus at week 72), the percentages of participants who reached that point varied across groups. In the four TMC435 groups, the reported figures were: 80.8% (75 mg, 12-week TMC435 course), 70.7% (75 mg, 24-week course), 77.9% (150 mg, 12-week course), and 84.8% (150 mg, 24-week course). In the placebo group, the reported figure was 64.9%. For a related secondary measure — no detectable virus at 24 weeks after the planned end of treatment — the reported figures were 82.1%, 74.7%, 80.5%, and 86.1% across the four TMC435 groups respectively, compared with 64.9% in the placebo group. An early measure at week 4 (called a rapid virologic response) showed no detectable virus in 68.0%–75.6% of TMC435 participants, compared with 5.2% in the placebo group. Some secondary outcome data points were only partially reported in the submitted results, so complete figures across all groups at every time point were not available. 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 2 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 diagnosed with a long-term (chronic) hepatitis C infection, specifically the type known as "genotype 1," and your blood tests show a high enough level of the virus (over 100,000 IU/mL)
- You have never received any treatment for hepatitis C before
- If you or your partner could become pregnant, you must be willing to use 2 effective forms of birth control during the trial
Who may not be able to join:
- You have severe scarring of the liver (cirrhosis) or signs that your liver is not working properly
- You also have HIV (the virus that causes AIDS)
- You have any medical reason why you cannot take the medications Pegasys or Copegus (confirm with trial site)
- You have a past or current medical condition that could put your safety at risk during the study (confirm with trial site)
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: Tibotec Pharmaceuticals, Ireland Clinical Trial, Tibotec Pharmaceuticals, 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 at Week 72 (SVRW72)
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.