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NCT01318694 Clinical Trial

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

Hepatitis C, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01318694
Other study ID # CDEB025A2301
Secondary ID 2010-022867-37
Status Completed
Phase Phase 3
First received March 17, 2011
Last updated April 1, 2016
Start date March 2011
Est. completion date August 2013

Study information
Verified date April 2016
Source Debiopharm International SA
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationKorea: Food and Drug AdministrationTaiwan: Department of HealthThailand: Food and Drug AdministrationVietnam: Ministry of HealthArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaMexico: Federal Commission for Sanitary Risks ProtectionCanada: Health CanadaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyItaly: Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: National Medicines AgencyRussia: Ministry of Health of the Russian FederationUnited Kingdom: Medicines and Healthcare Products Regulatory AgencySpain: Spanish Agency of MedicinesBelgium: Federal Agency for Medicinal Products and Health ProductsHong Kong: Department of Health
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 1073
Est. completion date August 2013
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

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
• 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
• Peg-IFN once weekly + Ribavirin BID + DEB025 600 mg QD
Peg-IFN once weekly + Ribavirin BID + DEB025 600 mg QD for 48 weeks
• PegIFN once weekly + Ribavirin + Placebo
PegIFN once weekly + Ribavirin + Placebo for 24 or 48 weeks

Locations
Country Name City State
Argentina Novartis Investigative Site Buenos Aires
Argentina Novartis Investigative Site Buenos Aires
Argentina Novartis Investigative Site Cordoba
Argentina Novartis Investigative Site Rosario Santa Fe
Argentina Novartis Investigative Site Rosario Santa Fe
Australia Novartis Investigative Site Darlinghurst New South Wales
Australia Novartis Investigative Site Fitzroy Victoria
Australia Novartis Investigative Site Greenslopes Queensland
Australia Novartis Investigative Site Kingswood New South Wales
Australia Novartis Investigative Site Kogarah New South Wales
Australia Novartis Investigative Site Westmead New South Wales
Belgium Novartis Investigative Site Brussel
Belgium Novartis Investigative Site Bruxelles
Belgium Novartis Investigative Site Gent
Canada Novartis Investigative Site Calgary Alberta
Canada Novartis Investigative Site Downsview Ontario
Canada Novartis Investigative Site London Ontario
Canada Novartis Investigative Site Toronto Ontario
Canada Novartis Investigative Site Toronto Ontario
Canada Novartis Investigative Site Vancouver British Columbia
Canada Novartis Investigative Site Vancouver British Columbia
Canada Novartis Investigative Site Vancouver British Columbia
France Novartis Investigative Site Clichy
France Novartis Investigative Site Grenoble
France Novartis Investigative Site Lyon Cedex 04
France Novartis Investigative Site Toulouse cedex 9
France Novartis Investigative Site Villejuif
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Essen
Germany Novartis Investigative Site Frankfurt
Germany Novartis Investigative Site Freiburg
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Hannover
Germany Novartis Investigative Site Kiel
Germany Novartis Investigative Site Köln
Germany Novartis Investigative Site Leipzig
Germany Novartis Investigative Site Mainz
Hong Kong Novartis Investigative Site Hong Kong
Hong Kong Novartis Investigative Site Hongkong
Hungary Novartis Investigative Site Bekescsaba
Hungary Novartis Investigative Site Budapest
Hungary Novartis Investigative Site Budapest
Hungary Novartis Investigative Site Budapest
Hungary Novartis Investigative Site Debrecen
Hungary Novartis Investigative Site Kaposvár
Hungary Novartis Investigative Site Pecs
Hungary Novartis Investigative Site Szekesfehervar
Italy Novartis Investigative Site Bologna BO
Italy Novartis Investigative Site Bologna
Italy Novartis Investigative Site Genova GE
Italy Novartis Investigative Site Milano MI
Italy Novartis Investigative Site Milano MI
Italy Novartis Investigative Site Milano MI
Italy Novartis Investigative Site Napoli
Italy Novartis Investigative Site Padova PD
Italy Novartis Investigative Site Palermo PA
Italy Novartis Investigative Site Pavia PV
Italy Novartis Investigative Site Roma RM
Italy Novartis Investigative Site Rozzano MI
Italy Novartis Investigative Site Torino TO
Korea, Republic of Novartis Investigative Site Busan
Korea, Republic of Novartis Investigative Site Busan
Korea, Republic of Novartis Investigative Site Incheon
Korea, Republic of Novartis Investigative Site Kyunggi Kyeonggi
Korea, Republic of Novartis Investigative Site Pusan
Korea, Republic of Novartis Investigative Site Seoul Korea
Korea, Republic of Novartis Investigative Site Seoul Korea
Korea, Republic of Novartis Investigative Site Yangsan-si Gyeongsangnam-Do
Mexico Novartis Investigative Site México Distrito Federal
Mexico Novartis Investigative Site Monterrey Nuevo León
Poland Novartis Investigative Site Bialystok
Poland Novartis Investigative Site Bydgoszcz
Poland Novartis Investigative Site Chorzów
Poland Novartis Investigative Site Kielce
Poland Novartis Investigative Site Lódz
Puerto Rico Novartis Investigative Site San Juan
Romania Novartis Investigative Site Bucharest District 1
Romania Novartis Investigative Site Bucharest District 3
Romania Novartis Investigative Site Bucharest
Romania Novartis Investigative Site Cluj Napoca
Romania Novartis Investigative Site Craiova
Romania Novartis Investigative Site Iasi
Romania Novartis Investigative Site Iasi Jud. Iasi
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Saint-Petersburg
Russian Federation Novartis Investigative Site St.- Petersburg
Spain Novartis Investigative Site Barcelona Catalunya
Spain Novartis Investigative Site Barcelona Catalunya
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Majadahonda Madrid
Spain Novartis Investigative Site Sevilla Andalucia
Spain Novartis Investigative Site Valencia Comunidad Valenciana
Taiwan Novartis Investigative Site Chia-Yi
Taiwan Novartis Investigative Site Kaohsiung
Taiwan Novartis Investigative Site Niaosong Township
Taiwan Novartis Investigative Site Taichung
Taiwan Novartis Investigative Site Taipei
Taiwan Novartis Investigative Site Yun-Lin
Thailand Novartis Investigative Site Bangkok
Thailand Novartis Investigative Site Bangkok
Thailand Novartis Investigative Site Chiang Mai
Thailand Novartis Investigative Site Khon Kaen
Thailand Novartis Investigative Site Songkla
United Kingdom Novartis Investigative Site Birmingham
United Kingdom Novartis Investigative Site London
United Kingdom Novartis Investigative Site London
United Kingdom Novartis Investigative Site London
United Kingdom Novartis Investigative Site Newcastle Upon Tyne
United Kingdom Novartis Investigative Site Nottingham
United States Novartis Investigative Site Arlington Texas
United States Novartis Investigative Site Baltimore Maryland
United States Novartis Investigative Site Baltimore Maryland
United States Novartis Investigative Site Beverly Hills California
United States Novartis Investigative Site Bradenton Florida
United States Novartis Investigative Site Brooklyn New York
United States Novartis Investigative Site Charlotte North Carolina
United States Novartis Investigative Site Dallas Texas
United States Novartis Investigative Site Dallas Texas
United States Novartis Investigative Site Fairfax Virginia
United States Novartis Investigative Site Fayetteville North Carolina
United States Novartis Investigative Site Houston Texas
United States Novartis Investigative Site Indianapolis Indiana
United States Novartis Investigative Site Maitland Florida
United States Novartis Investigative Site Minneapolis Minnesota
United States Novartis Investigative Site New York New York
United States Novartis Investigative Site New York New York
United States Novartis Investigative Site Newark New Jersey
United States Novartis Investigative Site Newport News Virginia
United States Novartis Investigative Site Oakland California
United States Novartis Investigative Site Omaha Nebraska
United States Novartis Investigative Site Salt Lake City Utah
United States Novartis Investigative Site San Antonio Texas
United States Novartis Investigative Site San Diego California
United States Novartis Investigative Site San Diego California
United States Novartis Investigative Site San Diego California
United States Novartis Investigative Site Shreveport Louisiana
United States Novartis Investigative Site Springfield Illinois
United States Novartis Investigative Site St. Louis Missouri
United States Novartis Investigative Site St. Louis Missouri
United States Novartis Investigative Site Tampa Florida
United States Novartis Investigative Site Ventura California
Vietnam Novartis Investigative Site Hanoi
Vietnam Novartis Investigative Site Ho Chi Minh

Sponsors (1)
Lead Sponsor Collaborator
Debiopharm International SA

Countries where clinical trial is conducted

United States,  Vietnam,  Argentina,  Australia,  Belgium,  Canada,  France,  Germany,  Hong Kong,  Hungary,  Italy,  Korea, Republic of,  Mexico,  Poland,  Puerto Rico,  Romania,  Russian Federation,  Spain,  Taiwan,  Thailand,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sustained Viral Response Week 12 (SVR 12) defined as serum HCV RNA undetectable by limit of detection (LOD) 24 weeks after treatment completion 12 weeks after treatment completion No
Secondary 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 4 weeks after treatment start No
Secondary Early Virological Response (EVR): serum HCV RNA reduction by at least 2Log10 or serum HCV RNA below LOQ 12 weeks after treatment start 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		 12 weeks after treatment start No
Secondary End of treatment response (ETR) - defined as HCV RNA undetectable by limit of detection 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 at treatment completion whenever it occurs, 12 and 48 weeks after treatment completion No
Secondary Change in liver enzyme (ALT and bilirubin) and hematological patient profiles (platelets, neutrophils, hemoglobin) during treatment phase. 48 weeks Yes
See also
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