Clinical trial NCT01215643: Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants
Official title: A Multicenter, Randomized, Open Label, Parallel-group Phase IIB Study on the Efficacy and Safety of Oral Regimens of DEB025 Alone or in Combination With Ribavirin Versus Standard of Care (Peg-IFNα2a Plus Ribavirin) in Treatment-naïve Hepatitis C Genotype 2 and 3 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C
Chronic Pain
Keywords: Chronic hepatitis C genotype 2
Chronic hepatitis C genotype 3
Cyclophilin inhibitor
Lead sponsor: Debiopharm International SA
Sponsor class: INDUSTRY
First posted: 2010-10-06
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is to investigate whether alisporivir (ALV; DEB025) alone or in combination with either ribavirin (RBV) or peginterferon alfa-2a (PEG) is more efficient compared to standard of care (PEG+RBV) in treatment-naïve participants with hepatitis C virus (HCV) genotype 2 and 3. In addition, triple therapy with DEB025 plus standard of care will be applied to participants not achieving rapid viral response (RVR) in the different arms.


Eligibility criteria: Inclusion criteria:

* Chronic hepatitis C viral infection
* Plasma HCV RNA level lower limit ≥ 10,000 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent at screening (no upper limit)
* HCV genotype 2 or 3
* No previous treatment for hepatitis C infection

Exclusion criteria:

* Evidence of cirrhosis at the time of screening
* Evidence of hepatocellular carcinoma at the time of screening
* Any other cause of relevant liver disease other than HCV
* Alanine aminotransferase (ALT) ≥ 10 times upper limit of normal (ULN)
* Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Percentage of Participants With Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ)
timeFrame: after 4 weeks of treatment
Secondary outcomes:
measure: Percentage of Participants With RVR After 4 Weeks of Treatment < the Limit of Detection (RVR4LOD)
timeFrame: after 4 weeks of treatment
measure: Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2)
timeFrame: after 4 weeks of treatment
measure: Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3)
timeFrame: after 4 weeks of treatment
measure: Percentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD)
timeFrame: after 12 weeks of treatment
measure: Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2)
timeFrame: after 12 weeks of treatment
measure: Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3)
timeFrame: after 12 weeks of treatment
measure: Percentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD)
timeFrame: at end of treatment, within 24 weeks
measure: Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2)
timeFrame: at end of treatment, within 24 weeks
measure: Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3)
timeFrame: at end of treatment, within 24 weeks
measure: Percentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD)
timeFrame: 12 weeks after the end of treatment
measure: Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2)
timeFrame: 12 weeks after the end of treatment
measure: Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3)
timeFrame: 12 weeks after the end of treatment
measure: Percentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD)
timeFrame: 24 weeks after the end of treatment
measure: Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2)
timeFrame: 24 weeks after the end of treatment
measure: Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3)
timeFrame: 24 weeks after the end of treatment
measure: Percentage of Participants With On-treatment Viral Breakthrough
timeFrame: within 24 weeks of treatment
measure: Percentage of Participants With Viral Relapse
timeFrame: within 24 weeks after the end of treatment
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Clinic
state: California
city: San Diego
country: United States
facility: Sharp Rees-Stealy Medical Group, Inc.
state: California
city: San Diego
country: United States
facility: Research and Education Inc.
state: California
city: Ventura
country: United States
facility: Island View Gastroenterology Associates
state: California
city: Honolulu
country: United States
facility: Hawai Medical Center East LLC
state: Hawaii
city: Topeka
country: United States
facility: Cotton O'Neil Clinical Research
state: Kansas
city: Springfield
country: United States
facility: The Office of Dr. Claudia Martorell
state: Massachusetts
city: St. Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Arlington
country: United States
facility: The North Texas Research Institute
state: Texas
city: Houston
country: United States
facility: Liver Associates of Texas
state: Texas
city: Houston
country: United States
facility: Liver Specialist of Texas
state: Texas
city: San Antonio
country: United States
facility: Alamo Medical Research
state: Texas
city: Kingswood
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Kogarah
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Westmead
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Greenslopes
country: Australia
facility: Novartis Investigative Center
state: Queensland
city: Clayton
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Fitzroy
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Gent
country: Belgium
facility: Novartis Investigative Site
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Vancouver
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Clichy Cedex
country: France
facility: Novartis Investigative Site
city: Creteil
country: France
facility: Novartis Investigative Site
city: Marseille
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Freiburg
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Trivandrum
country: India
facility: Novartis Investigative Site
state: Kerala
city: Mumbai
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Ludhiana
country: India
facility: Novartis Investigative Site
state: Punjab
city: Lucknow
country: India
facility: Novartis Investigative Site
state: Uttar Pradesh
city: Guwahati
country: India
facility: Novartis Investigative Site
city: Haryana
country: India
facility: Novartis Investigative Site
city: Hyderabad - Andhra Pradesh
country: India
facility: Novartis Investigative Site
city: Mumbai
country: India
facility: Novartis Investigative Site
city: New Delhi
country: India
facility: Novartis Investigative Site
city: Bologna
country: Italy
facility: Novartis Investigative Site
city: Brescia
country: Italy
facility: Novartis Investigative Site
city: Pavia
country: Italy
facility: Novartis Investigative Site
city: Roma
country: Italy
facility: Novartis Inestigative Site
city: Torino
country: Italy
facility: Novartis Investigative Site
city: Pusan
country: Korea, Republic of
facility: Novartis Inestigative Center
city: Pusan
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Korea Ltd.
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Bialystok
country: Poland
facility: Novartis Investigative Site
city: Lódz
country: Poland
facility: Novartis Investigative Site
city: Warsaw
country: Poland
facility: Novartis Investigative Site
city: San Juan
country: Puerto Rico
facility: Fundacion de Investigacion de Diego
city: Kaohsiung
country: Taiwan
facility: Novartis Investigative Site
city: Niaosong Township
country: Taiwan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Yun-Lin
country: Taiwan
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Chiang Mai
country: Thailand
facility: Novartis Investigative Site
city: Songkla
country: Thailand
facility: Novartis Investigative Site
city: Glasgow - Scotland
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Plymouth
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmceuticals
role: STUDY_DIRECTOR
References:
citation: Pawlotsky JM, Flisiak R, Sarin SK, Rasenack J, Piratvisuth T, Chuang WL, Peng CY, Foster GR, Shah S, Wedemeyer H, Hezode C, Zhang W, Wong KA, Li B, Avila C, Naoumov NV; VITAL-1 study team. Alisporivir plus ribavirin, interferon free or in combination with pegylated interferon, for hepatitis C virus genotype 2 or 3 infection. Hepatology. 2015 Oct;62(4):1013-23. doi: 10.1002/hep.27960. Epub 2015 Aug 10.