Efficacy and Safety of DEB025 Combined With Peg-IFN Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Relapsers and Non-responders

Brief Summary

Official Title: “A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Study on Efficacy and Safety of DEB025 Combined With Peg-IFN Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Relapsers and Non-responders to Previous Peg-IFN Alfa-2 Plus Ribavirin Treatment”

The study is to investigate whether HCV GT1 patients with a history of non-response/relapse to SOC benefit from treatment with triple therapy of DEB025 plus Peg-IFN and ribavirin compared to triple treatment with placebo matching DEB025 plus Peg-IFN and ribavirin

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: May 2013

Interventions Used in this Clinical Trial

  • Drug: DEB025 600 mg QD + SOC
    • DEB025 600 mg QD + peg-IFNα2a once weekly + RBV BID
  • Drug: DEB025 800 mg QD + SOC
    • DEB025 800 mg QD + peg-IFNα2a once weekly + RBV BID
  • Drug: placebo + SOC
    • Patients will change to active treatment if cEVR not reached), with delayed onset of DEB025 600 mg QD + SOC treatment due to non-response to placebo + SOC)
  • Drug: placebo + SOC
    • Patients will change to active treatment if cEVR not reached), with delayed onset of DEB025 400 mg BID + SOC treatment due to non-response to placebo + SOC)
  • Drug: DEB025 400 mg BID + SOC
    • DEB025 400 mg BID + peg-IFNα2a once weekly + RBV BID

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Treatment A
    • DEB025 600 mg QD + peg-IFNα2a once weekly + RBV BID
  • Experimental: Treatment B
    • DEB025 800 mg QD + peg-IFNα2a once weekly + RBV BID
  • Placebo Comparator: Treatment C1
    • Patients will change to active treatment if cEVR not reached), with delayed onset of DEB025 600 mg QD + SOC treatment due to non-response to placebo + SOC)
  • Placebo Comparator: Treatment C2
    • Patients will change to active treatment if cEVR not reached), with delayed onset of DEB025 600 mg QD + SOC treatment due to non-response to placebo + SOC)
  • Experimental: Treatment D
    • DEB025 400 mg BID + peg-IFNα2a once weekly + RBV BID

Outcome Measures for this Clinical Trial

Primary Measures

  • cEVR (complete early virologic response) i.e. HCV RNA < 25 IU/mL (by Limit of Quantitation, LOQ) ; the primary efficacy comparison is between DEB025 active plus peg-IFNα2a once weekly + RBV BID and DEB025 placebo plus peg-IFNα2a once weekly + RBV BID
    • Time Frame: 12 weeks
      Safety Issue?: No

Secondary Measures

  • SVR12: sustained virologic response 12 weeks following cessation of therapy, defined as HCV RNA negative (by LOQ)
    • Time Frame: 12 weeks post treatment
      Safety Issue?: No
  • cEVR after 12 week triple therapy with 600 mg DEB025 daily plus peg-IFNα2a once weekly + RBV BID versus 800 mg daily plus peg-IFNα2a once weekly + RBV BID.
    • Time Frame: 12 weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

Chronic hepatitis C G1 viral infection; Plasma HCV RNA level lower limit ≥ 1,000 IU/ml assessed by qPCR (quantitative polymerase chain reaction) or equivalent at screening, no upper limit; HCV genotype 1; Previous non-responders/relapsers to SOC after treatment for at least 12 weeks.

Exclusion Criteria

Treatment with any anti-HCV drug (whether approved or investigational) within 3 months prior to screening; Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, UNLESS they are using a highly effective contraception; Any other cause of relevant liver disease other than HCV; Other protocol-defined inclusion/exclusion criteria may apply.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Novartis Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01183169