Phase 3 Haemophilia Trial, Completed NCT01741545 Sponsor: Bristol-Myers Squibb Condition: Haemophilia
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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 51 people across two groups — 12 participants in Cohort A and 39 in Cohort B. The trial was measuring how the body responded to treatment for hepatitis C (HCV), a virus that affects the liver. The main thing being tracked was whether the virus became undetectable in participants' blood 12 weeks after finishing treatment — a result researchers call "SVR12" (sustained virologic response at 12 weeks). A number of additional measures were also tracked at different points during and after treatment. The reported data shows that for the main outcome (virus undetectable at 12 weeks after treatment), 91.7% of Cohort A participants and 89.7% of Cohort B participants reached that point. For the additional measures: at week 4 of treatment, the virus was undetectable in 91.7% of Cohort A and 76.9% of Cohort B; at week 12 of treatment, those figures were 91.7% and 92.3% respectively; and by the end of the full treatment course, 100% of participants in both groups had undetectable virus levels. At 24 weeks after finishing treatment, the reported figures were lower — 66.7% for Cohort A and 30.8% for Cohort B. The reported data also shows that 0% of participants in either group experienced certain blood abnormalities (low red blood cells, low white blood cells, or low platelets) during treatment. 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 Haemophilia Trial, Completed

NCT01741545
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 severe hemophilia, meaning your body produces less than 1% of the normal level of the clotting factor affected.
  • You have been infected with the hepatitis C virus (HCV) and also have hemophilia.
  • You are male and 18 years of age or older.
  • You have never previously been treated with a medication called interferon.

Who may not be able to join:

  • You are also infected with hepatitis B virus (HBV) or HIV.
  • You have long-term liver disease caused by something other than hepatitis C.
  • You have a substance in your blood called a Bethesda inhibitor, which can interfere with hemophilia treatment (confirm with trial site).
  • You currently have, or have a history of, high blood pressure in the vein that carries blood to your liver (a condition called portal hypertension).

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: Bristol-Myers Squibb, Bristol-Myers Squibb

Australian sites

Local Institution, Camperdown, New South Wales
Local Institution, Herston, Queensland
Local Institution, Adelaide, South Australia
Local Institution, Melbourne, Victoria
Local Institution, Herston,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Completed
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
31 March 2013
Est. completion
31 January 2015

Where this trial is recruiting

🇦🇺 Australia 🇫🇷 France 🇮🇹 Italy 🇳🇱 Netherlands 🇷🇴 Romania 🇷🇺 Russia 🇪🇸 Spain 🇺🇸 United States

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

Primary endpoints

Percentage of Participants Who Achieved Sustained Virologic Response (SVR12) at Follow-Up Week 12

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