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

Purpose

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

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

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Ribavirin Interferon alfa-2a Peginterferon Alfa-2a Hepatitis A Vaccines

U.S. FDA Resources

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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	461
Study Start Date:	August 2010
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Treatment B DEB025 800 mg QD + peg-IFNα2a once weekly + RBV BID	Drug: DEB025 800 mg QD DEB025 800 mg QD + peg-IFNα2a once weekly + RBV BID
Experimental: Treatment A DEB025 600 mg QD + peg-IFNα2a once weekly + RBV BID	Drug: DEB025 600 mg QD + SOC DEB025 600 mg QD + peg-IFNα2a once weekly + RBV BID
Placebo Comparator: Treatment C placebo + peg-IFNα2a once weekly + RBV BID	Drug: placebo + SOC placebo + 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)	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)
Experimental: Treatment D DEB025 400 mg BID + peg-IFNα2a once weekly + RBV BID	Drug: DEB025 400 mg BID + SOC DEB025 400 mg BID + peg-IFNα2a once weekly + RBV BID
Placebo Comparator: Treatment C2 placebo + peg-IFNα2a once weekly + RBV BID	Drug: placebo + SOC placebo + 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 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

Contacts and Locations

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

Show 63 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmceuticals

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:	August 2, 2012
Health Authority:	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 United States: Food and Drug Administration

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, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon Alfa-2a
Interferon-alpha

Ribavirin
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Immunologic Factors
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 17, 2012