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 719 people across seven treatment groups to study a drug called BI 201335 (at different doses and schedules) compared to a placebo, all in people with hepatitis C. Participants were split into two broad categories: those who had never been treated before (TN = treatment-naïve) and those who had been treated previously (TE = treatment-experienced). The trial was measuring the level of hepatitis C virus in participants' blood at various points during and after treatment, to see how many people had the virus fall below detectable levels. The reported data shows that for the main outcome — the percentage of people whose hepatitis C virus was undetectable 24 weeks after finishing all treatment (known as SVR24, a standard measure used in hepatitis C trials) — the figures varied considerably across groups. In the placebo group, 56.3% reached this point. Among treatment-naïve participants receiving BI 201335, the reported figures ranged from 72.5% to 83.8% depending on the dose. Among previously treated participants receiving BI 201335, the reported figures ranged from 28.2% to 40.8%. A second primary measure looked at virus levels four weeks after stopping an early phase of treatment in a subset of participants; the reported rates there ranged from 0% (placebo and one BI 201335 group) up to 75% in one treatment-naïve BI 201335 group. The reported data also shows results for several secondary measures taken at earlier time points. At week 2, the percentage of people with virus below the detectable threshold ranged from 1.4% (placebo) to 82.4% across groups. By week 4, those figures rose, ranging from 16.9% (placebo) to 93.7%. Measures at week 12 and combined week 4-plus-week-12 responses followed similar patterns across the groups. 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 ↗
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 chronic Hepatitis C, specifically genotype 1
- You have never been treated before with interferon, pegylated interferon, or ribavirin (common Hepatitis C medicines)
- Your Hepatitis C virus levels in the blood are at or above 100,000 IU/mL (a measure of how much virus is in your blood)
- You have had a liver tissue sample (biopsy) taken within the past 2 years showing signs of liver inflammation or scarring
- You have had a normal eye examination (looking at the back of the eye) within the past 6 months
- You are between 18 and 65 years old
- You are using adequate birth control (applies to both men and women)
Who may not be able to join:
- Your Hepatitis C involves more than one genotype (for example, a mix of types 1 and 2, 1 and 3, or 1 and 4)
- You have previously been treated with a type of medicine called a protease inhibitor
- Your liver disease is caused by something other than Hepatitis C
- You are HIV-1 or HIV-2 positive
- You are positive for Hepatitis B
- Your liver is not functioning properly (decompensated liver disease), or it has not functioned properly in the past
- You have, or have had, any type of cancer in the last 5 years
- You have had problems with alcohol or drug misuse in the past 12 months
- You have taken an experimental drug within the past 30 days (or longer, depending on the drug)
- You are known to be allergic to any ingredient in the study medicines
- You have a health condition that the doctor running the trial feels could put you at risk or affect your ability to participate (confirm with trial site)
- A specific protein in your blood called alpha-fetoprotein is above a certain level, which may indicate liver concerns (confirm with trial site)
- Certain liver-related blood test results are significantly above the normal range, including bilirubin, ALT, AST, or INR levels (confirm with trial site)
- You do not meet certain additional requirements related to the specific medicines used in this trial (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: Boehringer Ingelheim, Boehringer Ingelheim
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
9 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Virological Response 4 Weeks After the End of Treatment With BI 201335 or Placebo; Sustained Virological Response 24 Weeks (SVR24) After Completion of All Therapy
Can't join this trial?
Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.