Clinical trial NCT01447394: Safety and Efficacy Study of Pegylated Interferon Lambda Versus Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C
Official title: A Double-Blinded Randomized Control Study Evaluating the Efficacy and Safety of Pegylated Lambda Interferon Compared to Pegylated Alfa-2a Interferon, Each in Combination With Ribavirin, in the Treatment of Naive Genotype 1 or 4 Chronic Hepatitis C Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Hepatitis C Virus (HCV)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2011-10-06
Enrollment: 0
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 purpose of this study is to determine if 48 weeks of therapy with Pegylated Interferon Lambda plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC) compared to therapy with Pegylated Interferon Alfa-2a plus Ribavirin.


Eligibility criteria: Inclusion Criteria:

* Chronic hepatitis C, Genotype 1 or 4
* HCV Ribonucleic acid (RNA) ≥ 100,000 IU/mL at screening
* Liver biopsy documenting no cirrhosis (within prior 2 years) or cirrhosis (from any time prior to randomization). Where approved for staging of liver disease, non-invasive imaging may be used to assess the extent of liver disease. Subjects with compensated cirrhosis can enroll and will be capped at 10%
* Naive to prior anti-HCV therapy

Exclusion Criteria:

* Infected with HCV other than Genotype 1 or 4
* Positive Hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody or hepatitis D virus (HDV) at screening
* Evidence of liver disease other than HCV
* Active substance abuse
* Use of hematologic growth factors within 90 days prior to study randomization
* Evidence of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria

Primary outcomes:
measure: Efficacy of Lambda + Ribavirin (RBV) compared to Alfa + RBV in achieving a sustained virological response
timeFrame: At follow-up Week 24 (SVR24) following 48 weeks of treatment
measure: The safety of Lambda + RBV compared to Alfa + RBV in reducing cytopenic abnormalities
timeFrame: From Day 1 to end of Week 48 on-treatment
Secondary outcomes:
measure: Proportion of interferon-associated symptoms: a) Flu-like symptoms b) Musculoskeletal symptoms c) Neurologic symptoms d) Psychiatric symptoms e) Constitutional symptoms
timeFrame: From Day 1 to end of Week 48 on-treatment
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Local Institution
state: California
city: Rochester
country: United States
facility: Local Institution
state: New York
city: Houston
country: United States
facility: Local Institution
state: Texas
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Vaughan
country: Canada
facility: Local Institution
state: Ontario
city: Hong Kong
country: China
facility: Local Institution
state: Hong Kong
city: Bogota
country: Colombia
facility: Local Institution
city: Cali
country: Colombia
facility: Local Institution
city: Medellin
country: Colombia
facility: Local Institution
city: Hradec Kralove
country: Czech Republic
facility: Local Institution
city: Praha 4
country: Czech Republic
facility: Local Institution
city: Usti Nad Labem
country: Czech Republic
facility: Local Institution
city: Shebin Elkom
country: Egypt
facility: Local Institution
state: Menoufiya
city: Cairo
country: Egypt
facility: Local Institution
city: Lai Chi Kok
country: Hong Kong
facility: Local Institution
city: Tai Po
country: Hong Kong
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Debrecen
country: Hungary
facility: Local Institution
city: Miskolc
country: Hungary
facility: Local Institution
city: Hyderabad
country: India
facility: Local Institution
state: Andhra Pradesh
city: Coimbatore
country: India
facility: Local Institution
city: Gurgaon
country: India
facility: Local Institution
city: Ludhiana
country: India
facility: Local Institution
city: Nagpur
country: India
facility: Local Institution
city: New Delhi
country: India
facility: Local Institution
city: Dublin 8
country: Ireland
facility: Local Institution
state: Dublin
city: Dublin
country: Ireland
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: 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: Seoul
country: Korea, Republic of
facility: Local Institution
city: Suwon
country: Korea, Republic of
facility: Local Institution
city: Amsterdam
country: Netherlands
facility: Local Institution
city: Leiden
country: Netherlands
facility: Local Institution
city: Bialystok
country: Poland
facility: Local Institution
city: Bydgoszcz
country: Poland
facility: Local Institution
city: Chorzow
country: Poland
facility: Local Institution
city: Czeladz
country: Poland
facility: Local Institution
city: Kielce
country: Poland
facility: Local Institution
city: Krakow
country: Poland
facility: Local Institution
city: Lodz
country: Poland
facility: Local Institution
city: Lublin
country: Poland
facility: Local Institution
city: Olsztyn
country: Poland
facility: Local Institution
city: Pulawy
country: Poland
facility: Local Institution
city: Raciborz
country: Poland
facility: Local Institution
city: Sosnowiec
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Wroclaw
country: Poland
facility: Local Institution
city: Zielona Gora
country: Poland
facility: Local Institution
city: Bucharest
country: Romania
facility: Local Institution
city: Iasi
country: Romania
facility: Local Institution
city: Timisoara
country: Romania
facility: Local Institution
city: Ioshkar-Ola
country: Russian Federation
facility: Local Institution
state: Mari El
city: Kaluga
country: Russian Federation
facility: Local Institution
city: Lipetsk
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: Nizhniy Novgorod
country: Russian Federation
facility: Local Institution
city: Poselok Noviy
country: Russian Federation
facility: Local Institution
city: Samara
country: Russian Federation
facility: Local Institution
city: Saratov
country: Russian Federation
facility: Local Institution
city: Smolensk
country: Russian Federation
facility: Local Institution
city: Smolensk
country: Russian Federation
facility: Local Institution
city: St. Petersburg
country: Russian Federation
facility: Local Institution
city: St. Petersburg
country: Russian Federation
facility: Local Institution
city: St. Petersburg
country: Russian Federation
facility: Local Institution
city: St.Petersburg
country: Russian Federation
facility: Local Institution
city: St.Petersburg
country: Russian Federation
facility: Local Institution
city: Toliatti
country: Russian Federation
facility: Local Institution
city: Volgograd
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: Singapore
country: Singapore
facility: Local Institution
city: A Coruna
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Madrid
country: Spain
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: Taipei
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
city: Ankara
country: Turkey
facility: Local Institution
city: Bornova Izmir
country: Turkey
facility: Local Institution
city: Diyarbakir
country: Turkey
facility: Local Institution
city: Istanbul
country: Turkey
facility: Local Institution
city: Trabzon
country: Turkey
facility: Local Institution
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: Edinburgh
country: United Kingdom
facility: Local Institution
state: Midlothian
city: Birmingham
country: United Kingdom
facility: Local Institution
state: West Midlands
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: