Trial record 4 of 8 for:    DEB 025A HCV

Efficacy and Safety Study of DEB025/Alisporivir Combined to Peg-IFN and Ribavirin in Chronic Hepatitis C Genotype 1 naïve Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01318694
First received: March 17, 2011
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

This study will assess the safety and efficacy of Alisporivir when added to pegIFN and Ribavirin to optimize treatment in patient infected with the Hepatitis C virus who have not been previously treated for this condition


Condition Intervention Phase
Hepatitis C, Chronic
Drug: Peg-IFN once weekly + Ribavirin BID + DEB025 600 mg QD
Drug: Peg-IFN once weekly + Ribavirin BID + DEB025 400 mg BID
Drug: PegIFN once weekly + Ribavirin + Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Trial of the Efficacy and Safety of DEB025/Alisporivir in Combination With Peg-IFN and Ribavirin in Hepatitis C Genotype 1 Treatment-naïve

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Sustained Viral Response Week 12 (SVR 12) defined as serum HCV RNA undetectable by limit of detection (LOD) 24 weeks after treatment completion [ Time Frame: 12 weeks after treatment completion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rapid Virological response by limit of detection (RVR4LOD), Rapid Virological response by limit of quantification (RVR4LOQ) - defined as serum HCV RNA below LOD or LOQ respectively after 4 weeks of treatment [ Time Frame: 4 weeks after treatment start ] [ Designated as safety issue: No ]
  • Early Virological Response (EVR): serum HCV RNA reduction by at least 2Log10 or serum HCV RNA below LOQ 12 weeks after treatment start [ Time Frame: 12 weeks after treatment start ] [ Designated as safety issue: No ]

    partial Early Virological Response (pEVR): serum HCV RNA reduction by at least 2Log10 but still detectable 12 weeks after treatment start

    • complete Virological Response (cEVR): serum HCV RNA below LOD 12 weeks after treatment start
    • eRVRLOD: RVR4LOD achieved and maintained 12 weeks after treatment start
    • eRVRLOQ: RVR4LOQ achieved and maintained 12 weeks after treatment start

  • End of treatment response (ETR) - defined as HCV RNA undetectable by limit of detection [ Time Frame: at treatment completion whenever it occurs, 12 and 48 weeks after treatment completion ] [ Designated as safety issue: No ]
    Sustained Virological Response Week 12 (SVR12) defined as serum HCV RNA undetectable by limit of detection (LOD) 12 weeks after treatment completion Sustained Virological Response Week 48 (SVR48) defined as serum HCV RNA undetectable by limit of detection (LOD) 48 weeks after treatment completion

  • Change in liver enzyme (ALT and bilirubin) and hematological patient profiles (platelets, neutrophils, hemoglobin) during treatment phase. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 1073
Study Start Date: March 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A Drug: Peg-IFN once weekly + Ribavirin BID + DEB025 600 mg QD
Peg-IFN once weekly + Ribavirin BID + DEB025 600 mg QD for 24 or 48 weeks
Experimental: Treatment B Drug: Peg-IFN once weekly + Ribavirin BID + DEB025 400 mg BID
Peg-IFN once weekly + Ribavirin BID + DEB025 400 mg BID for 24 or 48 weeks
Experimental: Treatment C Drug: Peg-IFN once weekly + Ribavirin BID + DEB025 600 mg QD
Peg-IFN once weekly + Ribavirin BID + DEB025 600 mg QD for 48 weeks
Placebo Comparator: Treatment D Drug: PegIFN once weekly + Ribavirin + Placebo
PegIFN once weekly + Ribavirin + Placebo for 24 or 48 weeks

  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 viral
  • HCV genotype
  • No previous treatment for hepatitis C infection
  • Serum HCV RNA level ≥ 1000 IU/ml assessed by quantitative polymerase chain reaction or equivalent at screening, no upper limit
  • Liver evaluation prior to Baseline: liver biopsy within 3 years or Fibroscan within 6 months

Exclusion criteria:

  • HCV genotype different from genotype 1 or co-infection with other HCV genotype
  • Co-infection with Hepatitis B or HIV
  • Any other cause of relevant liver disease other than HCV
  • Presence or history of hepatic decompensation
  • ALT ≥ 10 times ULN, more than 1 episode of elevated bilirubin (>ULN) in past 6 months
  • 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: NCT01318694

  Show 147 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: NCT01318694     History of Changes
Other Study ID Numbers: CDEB025A2301, 2010-022867-37
Study First Received: March 17, 2011
Last Updated: July 17, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Korea: Food and Drug Administration
Taiwan: Department of Health
Thailand: Food and Drug Administration
Vietnam: Ministry of Health
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Mexico: Federal Commission for Sanitary Risks Protection
Canada: Health Canada
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
Russia: Ministry of Health of the Russian Federation
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Spain: Spanish Agency of Medicines
Belgium: Federal Agency for Medicinal Products and Health Products
Hong Kong: Department of Health

Keywords provided by Novartis:
Hepatitis C, chronic, controlled clinical trials, randomized, peginterferon alpha-2a, ribavirin, cyclophilin inhibitor, genotype 1, HCV, viral infection

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

ClinicalTrials.gov processed this record on August 01, 2014