Phase 3 Hepatitis C Trial, Completed NCT01542788 Sponsor: Gilead Sciences Condition: Hepatitis C
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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 209 people in the active treatment group (receiving a combination of sofosbuvir and ribavirin, referred to here as SOF+RBV) and 71 people in a placebo group (receiving dummy treatment). The trial was measuring whether people with hepatitis C could reach a point where the hepatitis C virus became undetectable in their blood — first at 4 weeks, then at 12 weeks, and again at 24 weeks after finishing treatment. The trial also tracked whether the virus came back during or after treatment, and whether any participants had to permanently stop taking the study drug due to unwanted side effects. The reported data shows that among those who received SOF+RBV, 78% had undetectable levels of the hepatitis C virus in their blood 12 weeks after finishing treatment (the main goal of the trial), compared with 0% in the placebo group. At 4 weeks after treatment, the reported figure for the SOF+RBV group was 83.1%, and at 24 weeks it was 77.8% — again, 0% for the placebo group at both timepoints. The reported data shows that 0% of participants in either group experienced what is called "viral breakthrough" (the virus becoming detectable again while still on treatment). However, a viral relapse rate of 20.5% was reported for the SOF+RBV group, meaning roughly 1 in 5 people in that group who had undetectable virus at the end of treatment saw the virus return afterwards. Regarding permanent stops due to unwanted effects, the reported data shows 1 participant in the SOF+RBV group and 0 in the placebo group stopped for this reason (from the 202 and 68 participants respectively assessed for this measure). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

NCT01542788
Completed Phase 3 🇦🇺 Australian site

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 Hepatitis C virus (HCV), specifically type 2 or type 3.
  • You have been assessed and found to have cirrhosis (scarring of the liver).
  • You are either unwilling to take interferon treatment, medically unable to take interferon treatment, or have previously tried interferon and could not tolerate it.
  • Your blood test results from screening fall within the acceptable ranges set by the trial.
  • You have not taken any experimental medication or used any experimental medical device in the 30 days before your screening visit.
  • If you are a woman who could become pregnant, or a sexually active man, you are willing to use highly effective birth control methods during the trial.

Who may not be able to join:

  • You have previously taken a specific type of Hepatitis C treatment that directly targets a part of the virus called NS5B (confirm with trial site if unsure whether your previous treatment applies).
  • You are currently pregnant, breastfeeding, or are a man whose partner is pregnant.
  • You have a history of serious liver failure or your liver has stopped functioning properly at any point (confirm with trial site).
  • You have a significant ongoing or past illness or major health condition that could interfere with your treatment, the assessments, or your ability to follow the trial plan.
  • You drink excessive amounts of alcohol or have a significant problem with substance misuse.

⚠️ 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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Australian sites

Westmead Hospital, Westmead, New South Wales
Royal Brisbane & Women's Hospital, Herston, Queensland
St. Vincent's Hospital, Melbourne,
Monash Medical Centre, Melbourne,

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

Status
Completed
Phase
Phase 3
Sponsor
Registry
ClinicalTrials.gov
Start date
1 March 2012
Est. completion
1 November 2012

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇳🇿 New Zealand Puerto Rico 🇺🇸 United States

4 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Percentage of Participants Achieving SVR12; Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov