OPTIMIZE: BID vs q8h telaprevir in HCV G1 naive

• Research type

  Research Study

• Full title

  A randomized, open-label, Phase 3 study of telaprevir administered twice daily or every 8 hours in combination with pegylated interferon alfa-2a and ribavirin in treatment-naïve subjects with genotype 1 chronic hepatitis C virus infection.

• IRAS ID

  64433

• Contact name

  Kosh Agarwal

• Sponsor organisation

  Quintiles Ltd

• Eudract number

  2010-021628-84

• ISRCTN Number

  tba

• Research summary

  This is a randomised, open-label, multicentre, multinational Phase 3 study in participants with chronic Hepatitis C infection (genotype 1) who have not received previous treatment. The purpose of the trial is to compare two dose regimens of the study medication, telaprevir, when prescribed in combination with standard therapy. Half of the participants will take 750mg of telaprevir every 8 hours, and the other half will take 1125 mg of telaprevir twice a day. In addition to the telaprevir all participants will receive a standard treatment regimen of pegylated interferon alfa-2a (Peg-IFN) and Ribavirin (RBV). Participants will receive telaprevir treatment for 12 weeks, and the standard treatments for either 24 or 48 weeks depending on response.Telaprevir is a protease-inhibitor which works by blocking the enzyme protease which is involved in Hepatitis C reproduction.The primary objective of the trial is to find out whether the twice a day regimen is as effective as the 8 hourly regimen. Secondary objectives are to evaluate the safety and tolerability of telaprevir, to study how telaprevir is processed by the body by studying blood and urine samples, to find out whether a certain genotype (IB28B) has any effect on the response of the virus, and to study changes in amino acid sequences.The total study duration is 76 weeks, and 704 participants will be recruited. Study assessments include blood and urine tests, ECGs and patient surveys/questionnaires.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  10/H0711/87

• Date of REC Opinion

  23 Dec 2010

• REC opinion

  Further Information Favourable Opinion