Clinical trial NCT01616524: Safety and Efficacy Study of Pegylated Interferon Lambda With and Without Daclatasvir, Compared to Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C Genotype 2 and 3
Official title: A Phase 3, Randomized, Double-Blind, Controlled Study Evaluating the Efficacy and Safety of Peginterferon Lambda-1a, With and Without Daclatasvir, Compared to Peginterferon Alfa-2a, Each in Combination With Ribavirin, in the Treatment of Naïve Genotype 2 and 3 Chronic Hepatitis C Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C Virus (HCV)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2012-06-11
Enrollment: 880
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if 24 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and 12 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and Daclatasvir will be safe and effective for treatment of hepatitis C compared to 24 weeks of treatment with Pegylated Interferon Alfa-2a plus Ribavirin


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Chronic hepatitis C, Genotype 2 or 3
* Naïve to prior anti-HCV therapy

Exclusion Criteria:

* Infected with HCV other than Genotype 2 or 3
* Positive Hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody at screening
* Evidence of liver disease other than HCV
* Active substance abuse
* Evidence of decompensated cirrhosis

Primary outcomes:
measure: Proportion of subjects who achieve Sustained Virologic Response at post-treatment follow-up week 12 (SVR12)
timeFrame: Post-treatment follow-up week 12
Secondary outcomes:
measure: Proportion of subjects with Rapid virologic response (RVR) [undetectable Hepatitis C virus (HCV) Ribonucleic acid (RNA)]
timeFrame: On-treatment Week 4
measure: Proportion of subjects with treatment emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, neutropenia as defined by ANC < 750 mm3 or thrombocytopenia as defined by platelets < 50,000 mm3)
timeFrame: Up to week 12 or week 24
measure: Proportion of subjects with on-treatment interferon-associated flu-like symptoms (as defined by pyrexia or chills or pain)
timeFrame: Up to week 12 or week 24
measure: Proportion of subjects with on-treatment musculoskeletal symptoms (as defined by arthralgia or myalgia or back pain)
timeFrame: Up to week 12 or week 24
measure: Proportion of subjects with Sustained Virologic Response at post-treatment follow-up week 24 (SVR24) by treatment group
timeFrame: Post-treatment week 24
measure: Proportion of subjects with on-treatment Serious adverse events (SAEs)
timeFrame: Up to week 12 or week 24
measure: Proportion of subjects with dose reductions
timeFrame: Up to week 12 or week 24
measure: Proportion of subjects who discontinue due to Adverse events (AEs)
timeFrame: Up to week 12 or week 24
measure: Proportion of subjects with SVR12 in subjects with genotype-3 (GT-3) chronic HCV infection
timeFrame: Post-treatment follow-up week 12
measure: Proportion of subjects with on-treatment constitutional symptoms (fatigue or asthenia)
timeFrame: Up to week 12 or week 24
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: San Diego
country: United States
facility: Precision Research Institute, Llc
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group
state: California
city: San Francisco
country: United States
facility: University Of California, San Francisco/Sf General Hospital
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: New Haven
country: United States
facility: Yale University School Of Medicine
state: Connecticut
city: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: Orlando
country: United States
facility: Orlando Infectious Disease Center
state: Florida
city: Marietta
country: United States
facility: Gastrointestinal Specialists Of Georgia
state: Georgia
city: Honolulu
country: United States
facility: The Queen'S Liver Center
state: Hawaii
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants For Clinical Research
state: Ohio
city: Tulsa
country: United States
facility: Healthcare Research Consultants
state: Oklahoma
city: Pittsburgh
country: United States
facility: University Of Pittsburgh Medical Center, Ctr For Liver Diseases
state: Pennsylvania
city: Arlington
country: United States
facility: Texas Clinical Research Institute, Llc
state: Texas
city: Houston
country: United States
facility: St. Luke'S Episcopal Hospital - Baylor College Of Medicine
state: Texas
city: Murray
country: United States
facility: Clinical Research Centers Of America
state: Utah
city: Autonoma
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Ciudad De Buenos Aires
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Ciudad De Buenos Aires
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Mar Del Plata
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Quilmes
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Prov De Santa Fe
country: Argentina
facility: Local Institution
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Cordoba
country: Argentina
facility: Local Institution
city: Camperdown
country: Australia
facility: Local Institution
state: New South Wales
city: Concord
country: Australia
facility: Local Institution
state: New South Wales
city: Darlinghurst
country: Australia
facility: Local Institution
state: New South Wales
city: Randwick
country: Australia
facility: Local Institution
state: New South Wales
city: Westmead Nsw
country: Australia
facility: Local Institution
state: New South Wales
city: Brisbane
country: Australia
facility: Local Institution
state: Queensland
city: Greenslopes
country: Australia
facility: Local Institution
state: Queensland
city: Herston
country: Australia
facility: Local Institution
state: Queensland
city: Adelaide
country: Australia
facility: Local Institution
state: South Australia
city: Clayton Vic
country: Australia
facility: Local Institution
state: Victoria
city: Fitzroy
country: Australia
facility: Local Institution
state: Victoria
city: Melbourne
country: Australia
facility: Local Institution
state: Victoria
city: Parville
country: Australia
facility: Local Institution
state: Victoria
city: Fremantle
country: Australia
facility: Local Institution
state: Western Australia
city: Brussels
country: Belgium
facility: Local Institution
city: Leuven
country: Belgium
facility: Local Institution
city: Liege
country: Belgium
facility: Local Institution
city: Santiago
country: Chile
facility: Local Institution
state: Metropolitana
city: Hus
country: Finland
facility: Local Institution
city: Clichy Cedex
country: France
facility: Local Institution
city: Creteil Cedex
country: France
facility: Local Institution
city: Montpellier Cedex 5
country: France
facility: Local Institution
city: Nice Cedex 3
country: France
facility: Local Institution
city: Athens
country: Greece
facility: Local Institution
city: Thessaloniki
country: Greece
facility: Local Institution
city: Hong Kong
country: Hong Kong
facility: Local Institution
city: Tai Po
country: Hong Kong
facility: Local Institution
city: Firenze
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Napoli
country: Italy
facility: Local Institution
city: Novara
country: Italy
facility: Local Institution
city: Fukuoka-shi
country: Japan
facility: Local Institution
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Local Institution
state: Fukuoka
city: Hiroshima-Shi
country: Japan
facility: Local Institution
state: Hiroshima
city: Sapporo-shi
country: Japan
facility: Local Institution
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Local Institution
state: Hyogo
city: Tsuchiura-shi
country: Japan
facility: Local Institution
state: Ibaraki
city: Takamatsu-shi
country: Japan
facility: Local Institution
state: Kagawa
city: Kagoshima-shi
country: Japan
facility: Local Institution
state: Kagoshima
city: Kawasaki-shi
country: Japan
facility: Local Institution
state: Kanagawa
city: Okayama-shi
country: Japan
facility: Local Institution
state: Okayama
city: Iruma-gun
country: Japan
facility: Local Institution
state: Saitama
city: Bunkyo-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Minato-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Musashino-shi
country: Japan
facility: Local Institution
state: Tokyo
city: Wakayama-shi
country: Japan
facility: Local Institution
state: Wakayama
city: Fukuoka
country: Japan
facility: Local Institution
city: Miyazaki
country: Japan
facility: Local Institution
city: Saga
country: Japan
facility: Local Institution
city: Saitama
country: Japan
facility: Local Institution
city: Busan
country: Korea, Republic of
facility: Local Institution
city: Busan
country: Korea, Republic of
facility: Local Institution
city: Daegu
country: Korea, Republic of
facility: Local Institution
city: Daegu
country: Korea, Republic of
facility: Local Institution
city: Gyeonggi-do
country: Korea, Republic of
facility: Local Institution
city: Gyeonggi-do
country: Korea, Republic of
facility: Local Institution
city: Gyeongsangnam-do
country: Korea, Republic of
facility: Local Institution
city: Incheon
country: Korea, Republic of
facility: Local Institution
city: Incheon
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Mexico City
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Mexico
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Tlalpan
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Distrito Federal
country: Mexico
facility: Local Institution
city: Guadalajara
country: Mexico
facility: Local Institution
city: Mexico City
country: Mexico
facility: Local Institution
city: Amsterdam
country: Netherlands
facility: Local Institution
city: Leiden
country: Netherlands
facility: Local Institution
city: Auckland
country: New Zealand
facility: Local Institution
city: Chelyabinsk
country: Russian Federation
facility: Local Institution
city: Irkutsk
country: Russian Federation
facility: Local Institution
city: Krasnoyarsk
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Saint-Petersburg
country: Russian Federation
facility: Local Institution
city: Saint-Petersburg
country: Russian Federation
facility: Local Institution
city: Samara
country: Russian Federation
facility: Local Institution
city: Smolensk
country: Russian Federation
facility: Local Institution
city: St. Petersburg
country: Russian Federation
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
city: Kaohsiung
country: Taiwan
facility: Local Institution
city: Kaohsiung
country: Taiwan
facility: Local Institution
city: Taichung
country: Taiwan
facility: Local Institution
city: Tainan
country: Taiwan
facility: Local Institution
city: Yunlin
country: Taiwan
facility: Local Institution
city: Hull
country: United Kingdom
facility: Local Institution
state: Humberside
city: Nottingham
country: United Kingdom
facility: Local Institution
state: Nottinghamshire
city: Birmingham
country: United Kingdom
facility: Local Institution
state: West Midlands
city: London
country: United Kingdom
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: