Phase 3 Hepatitis C Trial, Completed NCT01241760 Sponsor: Janssen Infectious Diseases BVBA 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 740 adults with hepatitis C — 371 in one group and 369 in the other. Both groups received a combination of three medicines: telaprevir (taken either every 8 hours or twice daily) together with two other hepatitis C drugs, peginterferon and ribavirin. The trial was primarily measuring what proportion of participants had undetectable levels of the hepatitis C virus in their blood 12 weeks after finishing their planned course of treatment — a result known as a "sustained virologic response" or SVR (meaning the virus was no longer measurable at that later check-up point). The reported data shows that for the primary measure — virus undetectable at 12 weeks after the planned end of treatment — 72.8% of participants in the every-8-hours group and 74.3% in the twice-daily group met that threshold. For a similar check at 24 weeks after planned treatment end, the figures were 72.8% and 74.8% respectively, and at 72 weeks from the start of treatment they were 69.0% and 70.2%. The reported data also shows that around 9.7% and 10.3% of participants in each group respectively had to stop all study drugs early because the virus remained detectable at levels that triggered a pre-set stopping rule. Separately, 7.2% and 7.7% of participants in each group were recorded as having relapsed — meaning the virus became detectable again during the follow-up period after it had previously been undetectable. 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

NCT01241760
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 a long-term (chronic) hepatitis C infection of a specific type called "genotype 1," with a measurable level of the virus in your blood
  • You have never had any treatment for hepatitis C before
  • You have had a liver biopsy in the last 2 years, or you are willing to have one done during the screening period before the trial begins
  • If you have liver scarring (cirrhosis), a specific protein level in your blood (AFP) must be at or below a certain level — if it is higher, you will need an ultrasound scan to check there is no growth on the liver
  • If you are a woman who could become pregnant, or a man who has not had a vasectomy and whose partner could become pregnant, you must agree to use 2 reliable forms of birth control — from the start of screening until 6 months after your last dose of medication (for women) or 7 months (for men)

Who may not be able to join:

  • You have a type of hepatitis C other than genotype 1, or you have more than one subtype of the virus at the same time
  • You have an existing mental health (psychiatric) condition
  • You have a history of serious liver failure or have significant liver problems beyond hepatitis C
  • You are also infected with HIV or hepatitis B
  • You currently have cancer, or have been diagnosed with cancer in the past 5 years (except for a type of skin cancer called basal cell carcinoma that has already been treated)

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

Principal Investigator: Janssen Infectious Diseases BVBA Clinical Trial, Janssen Infectious Diseases BVBA

Australian sites

, Adelaide,
, Camperdown,
, Clayton,
, Darlinghurst,
, Fitzroy,
, Greenslopes,
, Melbourne,
, Perth,

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
Janssen Infectious Diseases BVBA
Registry
ClinicalTrials.gov
Start date
1 December 2010
Est. completion
1 August 2012

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇫🇷 France 🇩🇪 Germany 🇮🇪 Ireland 🇲🇽 Mexico 🇵🇱 Poland 🇪🇸 Spain 🇸🇪 Sweden 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Drugs (SVR12 Planned)

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