Phase 2 Hepatitis C Trial, Completed NCT01428063 Sponsor: Bristol-Myers Squibb 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 (NCT01428063) enrolled 227 people with hepatitis C across three treatment groups: 99 received daclatasvir plus asunaprevir; 122 received daclatasvir, asunaprevir, and two additional medicines (pegylated interferon and ribavirin); and 6 received daclatasvir with just the two additional medicines. The trial was measuring how many participants had undetectable levels of the hepatitis C virus in their blood at various points during and after treatment — including at 4 weeks, 12 weeks, and at the end of treatment. The main goal (the primary outcome) focused specifically on people with a genotype 1 strain of hepatitis C who had not responded to previous treatment. The reported data shows that for the primary outcome — participants in the daclatasvir plus asunaprevir plus interferon and ribavirin group who had previously not responded to treatment — 94.6% had undetectable virus levels at 12 weeks after finishing treatment (known as SVR12, meaning the virus was no longer detectable 12 weeks after the course ended). For the secondary outcomes, the reported SVR12 figures varied across different subgroups. For example, among those who had previously failed a different antiviral called asunaprevir, 100% reached SVR12, while among those who had previously failed daclatasvir, 40% did. Across other measures taken during treatment — such as how many people had undetectable virus at week 4 and week 12 of treatment — the reported figures generally ranged from around 64% to 100% depending on the group and the time point measured. 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 2 Hepatitis C Trial, Completed

NCT01428063
Completed Phase 2 🇦🇺 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 must have previously taken part in a clinical trial involving one of these experimental drugs (BMS-790052, BMS-650032, or BMS-791325) and were in the control group, meaning you received the standard treatment (pegIFNα-2a/ribavirin) plus a placebo instead of the experimental drug
  • You must have Hepatitis C virus (HCV) of genotype 1, 2, 3, or 4 — but not a mix of more than one genotype at the same time
  • The Hepatitis C virus must still be detectable in your blood at the time of joining

Who may not be able to join:

  • You cannot join if you left a previous BMS Hepatitis C trial early because of a bad reaction or side effect related to the standard treatment (pegIFNα-2a/ribavirin)
  • You cannot join if you have received any other Hepatitis C treatment after your participation in the earlier BMS trial
  • You cannot join if you test positive for Hepatitis B, HIV-1, or HIV-2 at the screening stage
  • You cannot join if you have a liver condition caused by something other than Hepatitis C
  • You cannot join if there is evidence that your liver disease has reached an advanced stage where the liver is no longer functioning properly (sometimes called decompensated cirrhosis), as shown by scans or a liver biopsy

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 21 July 2026
Phase 2: approximately ~30% 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, Darlinghurst, New South Wales
Local Institution, Kogarah, New South Wales
Local Institution, Westmead Nsw, New South Wales
Local Institution, Adelaide, South Australia
Local Institution, Clayton Vic, Victoria
Local Institution, Fitzroy, Victoria
Local Institution, Heidelberg, Victoria
Local Institution, Melbourne, Victoria
Local Institution, Fremantle, Western Australia
Local Institution, Perth, Western Australia

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 2
Registry
ClinicalTrials.gov
Start date
1 September 2011
Est. completion
1 September 2014

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇨🇦 Canada 🇩🇰 Denmark 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇮🇪 Ireland 🇮🇹 Italy 🇲🇽 Mexico 🇳🇿 New Zealand 🇵🇱 Poland 🇰🇷 South Korea 🇪🇸 Spain 🇸🇪 Sweden 🇹🇼 Taiwan 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) for All Nonresponders With Genotype 1 Hepatitis C Virus (HCV)

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: 21 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