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 (NCT01132313) enrolled a total of 488 participants across four parts, testing different combinations and durations of two antiviral medicines — referred to as DBV and FDV — for the treatment of hepatitis C. The trial was divided into separate parts, each looking at slightly different doses, dosing schedules, or treatment lengths. The main things being measured were how many participants showed very low or undetectable levels of the hepatitis C virus in their blood — either after four weeks of treatment (called a "rapid virological response") or twelve weeks after finishing treatment (called a "sustained virological response," meaning the virus remained undetectable after treatment ended). The reported data shows the following for the primary (main) outcomes. In Part 1, which tested a shorter four-week course, 73.3% of participants on the lower dose and 100% on the higher dose had very low virus levels at the four-week mark. In Part 2, which tested longer treatment courses of 16 to 40 weeks, the percentage of participants who had undetectable virus levels twelve weeks after finishing treatment ranged from about 39% (in the group that did not receive an additional medicine called RBV) up to about 69% (in a group using a twice-daily dosing schedule). In Parts 3 and 4, the reported data shows figures ranging from about 12% to 66% across different groups, though results for two of the Part 4 groups were listed as not available. For several of the secondary (additional) outcome measures — such as how quickly virus levels dropped — only partial figures were reported in the submitted data, and some results were not reported at all. 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 27140229) ↗
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 a long-term hepatitis C infection that is specifically "genotype 1" (a particular strain of the virus)
- For Parts 1–3: You have never been treated before with interferon, pegylated interferon, ribavirin, or any direct-acting antiviral medication for hepatitis C
- For Part 4: You have previously been treated with pegylated interferon and ribavirin, but the treatment did not work (known as a "null-response")
- Your hepatitis C virus levels in the blood are at or above a certain level (10,000 IU/mL) at the initial screening
- You have had a liver biopsy (a small tissue sample taken from the liver) within the last two years, or a fibroscan (a painless scan to check liver health) within the last six months
- You are between 18 and 75 years old
Who may not be able to join:
- You have a hepatitis C infection involving more than one type (mixed genotype)
- Your liver disease is caused by something other than hepatitis C
- You have tested positive for HIV
- You have a hepatitis B infection
- Your liver has stopped working properly, or has done so in the past (decompensated liver disease)
- You have had or are suspected to have cancer within the last 5 years
- You have ongoing or a history of sensitivity to light or recurring skin rashes
- You have had problems with alcohol or drug misuse (other than cannabis) in the past 12 months
- Your body mass index (a measure of weight relative to height) is below 18 or above 35
- You have taken any experimental (unapproved) drugs within 30 days before joining, or plan to do so during the trial
- You have a known allergy or sensitivity to any ingredient in the study drugs
- You have any other health condition that the doctor running the trial feels could affect your ability to take part or could affect the results (confirm with trial site)
- Your blood protein levels (alpha fetoprotein) are above a certain threshold, which may suggest liver concerns — this will be checked at screening (confirm with trial site)
- Certain liver-related blood test results are outside acceptable ranges, including bilirubin, liver enzymes (AST or ALT), and a blood clotting measure (INR) (confirm with trial site)
- You need to take steroid medications regularly (such as corticosteroids taken by mouth or injection)
- You have received certain antiviral, immune-boosting, or blood-stimulating treatments within 30 days before joining
- You have taken certain herbal supplements — silymarin, glycyrrhizin, or Sho-saiko-to — within 30 days before joining
- You have any medical reasons why you cannot take pegylated interferon or ribavirin (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
2 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Part 1: Rapid Virological Response (RVR); Part 2: Sustained Virological Response (SVR); Part 3 and 4: Sustained Virological Response (SVR)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.