BMS790052 vs Telaprevir + Peg+RBV in Treatment-naive Hepatitis C Pts

• Research type

  Research Study

• Full title

  A Phase 3 Evaluation of BMS-790052 (Daclatasvir) Compared with Telaprevir in Combination with Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Patients with Chronic Hepatitis-C

• IRAS ID

  96515

• Contact name

  Kosh Agarwal

• Sponsor organisation

  Bristol Myers Squibb

• Eudract number

  2011-004237-14

• Clinicaltrials.gov Identifier

  NCT01492426

• Research summary

  A Phase 3 Evaluation of BMS-790052 (Daclatasvir) Compared with Telaprevir in Combination with Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Patients with Chronic Hepatitis-C Treatment options for people chronically infected with hepatitis C virus are limited. Current treatment involves taking a combination of two drugs called pegylated interferon alpha (pegIFN alpha) and ribavirin for 24-48 weeks. However, new drugs such as telaprevir have shown significant improvement in effectiveness when added to pegIFN alpha and ribavirin. It is therefore expected that ??triple therapy? combining pegIFN alpha/ribavirin with new drugs like telaprevir will likely be used to treat Hepatitis C Genotype 1 in places where these drugs are available. Despite the advancement in treatment, there still remains additional room for improving safety and efficacy. The study drug, BMS-790052 (a tablet), is being studied as a potential treatment option to help address this need. The purpose of this study is to find out about the safety and effectiveness of the BMS-790052 compared with telaprevir, when added with pegIFN alpha and ribavirin for a total of 24 or 48 weeks of treatment. Two-thirds of patients will receive BMS-790052, and one-third of patients will receive telaprevir. All patients will receive pegIFN alpha and ribavirin. The patient and study doctor will know which treatment they are receiving at all times. Participating patients will be involved in the study for 72 weeks in total and will undergo physical examinations, multiple blood tests, a heart function test and regular pregnancy tests (because ribavirin can cause birth defects). A liver biopsy or fibroscan may also be required. Patients will be asked to complete a medication diary and will be regularly monitored. Treatment will be stopped if they do not respond or cannot tolerate side effects. Globally, the study will begin in February 2012 and approximately 600 patients will participate worldwide. In the UK, the study will begin in April 2012 and is due to end in May 2014. The study is funded by Bristol-Myers Squibb.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  12/LO/0175

• Date of REC Opinion

  13 Feb 2012

• REC opinion

  Favourable Opinion