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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01183169
First received: August 16, 2010
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

The study is to investigate whether HCV GT1 patients with a history of non-response/relapse to PegIFN + RBV 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


Condition Intervention Phase
Hepatitis C Chronic
Drug: DEB025 600 mg QD + PegIFN + RBV
Drug: DEB025 800 mg QD + PegIFN + RBV
Drug: placebo + PegIFN + RBV
Drug: DEB025 400 mg BID + PegIFN + RBV
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SVR12: sustained virologic response 12 weeks following cessation of therapy, defined as HCV RNA negative (by LOQ) [ Time Frame: 12 weeks post treatment ] [ Designated as 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 versus 400 mg BID plus peg-IFNα2a once weekly + RBV BID. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 459
Study Start Date: August 2010
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A
DEB025 600 mg QD + peg-IFNα2a once weekly + RBV BID
Drug: DEB025 600 mg QD + PegIFN + RBV
DEB025 600 mg QD + peg-IFNα2a once weekly + RBV BID
Experimental: Treatment B
DEB025 800 mg QD + peg-IFNα2a once weekly + RBV BID
Drug: DEB025 800 mg QD + PegIFN + RBV
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 + PegIFN + RBV treatment due to non-response to placebo + PegIFN + RBV)
Drug: placebo + PegIFN + RBV
Patients will change to active treatment if cEVR not reached), with delayed onset of DEB025 600 mg QD + PegIFN + RBV treatment due to non-response to placebo + PegIFN + RBV)
Placebo Comparator: Treatment C2
Patients will change to active treatment if cEVR not reached), with delayed onset of DEB025 400 mg QD + PegIFN + RBV treatment due to non-response to placebo + PegIFN + RBV)
Drug: placebo + PegIFN + RBV
Patients will change to active treatment if cEVR not reached), with delayed onset of DEB025 400 mg BID + PegIFN + RBV treatment due to non-response to placebo + PegIFN + RBV)
Experimental: Treatment D
DEB025 400 mg BID + peg-IFNα2a once weekly + RBV BID
Drug: DEB025 400 mg BID + PegIFN + RBV
DEB025 400 mg BID + peg-IFNα2a once weekly + RBV BID

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 PegIFN + RBV 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01183169

  Show 75 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01183169     History of Changes
Other Study ID Numbers: CDEB025A2210, 2010-020033-14
Study First Received: August 16, 2010
Last Updated: July 17, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Italy: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Spain: Spanish Agency of Medicines
Taiwan: Department of Health
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Hepatitis C
chronic
controlled clinical trials
randomized
peginterferon alfa2a
ribavirin
cyclophilin inhibitor
DEB025
genotype 1
HCV
viral infection

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014