Clinical trial NCT01598090: Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir
Official title: A Phase 3 Blinded Randomized Study of Peginterferon Lambda-1a and Ribavirin Compared to Peginterferon Alfa-2a and Ribavirin, Each Administered With Telaprevir in Subjects With Genotype-1 Chronic Hepatitis C Who Are Treatment-naive or Relapsed on Prior Treatment With Peginterferon Alfa-2a and Ribavirin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C Virus
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2012-05-15
Enrollment: 881
Sex: ALL
Standard ages: CHILD
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 whether Peginterferon Lambda-1a (Lambda) combined with Ribavirin (RBV) and Telaprevir (TVR) is effective in the treatment of chronic Hepatitis C (CHC) compared to Peginterferon Alfa-2a (alfa-2a) combined with RBV and Telaprevir.


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

Inclusion Criteria:

* Chronic hepatitis C genotype 1. GT-1b Capped at 50 % of naïve subjects
* Naives to prior anti-HCV therapy \[Interferon (IFN) and direct antiviral agent (DAA) based\]
* Relapsers (defined as subjects who had undetectable HCV ribonucleic acid (RNA) on prior treatment regimen of alfa-2a/RBV and Hepatitis C Virus (HCV) RNA \> 25IU/mL after discontinuation of treatment). Capped at 20%
* HCV RNA ≥ 100,000 IU/mL
* Subjects with compensated cirrhosis can be enrolled and will be capped at approximately 10%
* Seronegative for human immunodeficiency virus (HIV) and hepatitis B surface antigen (HBsAg)
* Men or women, 18-70 years of age

Exclusion Criteria:

* Chronic liver disease due to causes other than chronic HCV
* Current or past evidence of decompensation
* Conditions that preclude the use of Alfa/RBV/TVR per respective labels
* Diagnosed or suspected hepatocellular carcinoma

Primary outcomes:
measure: Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part A
timeFrame: Assessed at Week 4 and Week 12, week 12 reported
measure: Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B
timeFrame: Follow-up Week 12
measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A
timeFrame: Day 1 of treatment up to Week 48
Secondary outcomes:
measure: Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part A
timeFrame: Follow-up Week 12
measure: Percentage of Subjects With Sustained Virologic Response at Follow-Up Week 24 (SVR24) - Part A
timeFrame: Follow up week 24
measure: Percentage of Treatment-Naïve Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B
timeFrame: Follow-up Week 12
measure: Percentage of Participants With Treatment Emergent Cytopenic Abnormalities - Part B
timeFrame: After Day 1 of treatment up to Week 48
measure: Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part B
timeFrame: Week 4 and Week 12
measure: Percentage of Participants With On-Treatment Flu-Like Symptoms And Musculoskeletal Symptoms- Part B
timeFrame: After Day 1 of treatment up to Week 48
measure: Percentage of Participants With Sustained Virologic Response at Follow- upWeek 24 (SVR24) - Part B
timeFrame: Follow-up Week 24
measure: Percentage of Participants With Rash
timeFrame: After Day 1 of treatment up to Week 48
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Gastroenterology Associates, P.C.
state: Alabama
city: Birmingham
country: United States
facility: The Kirklin Clinic
state: Alabama
city: Birmingham
country: United States
facility: The University Of Alabama Of Birmingham
state: Alabama
city: Anaheim
country: United States
facility: Anaheim Clinical Trials Llc
state: California
city: Garden Grove
country: United States
facility: Sc Clinical Research, Inc.
state: California
city: Long Beach
country: United States
facility: Va Long Beach Healthcare System
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: Va Greater Los Angeles Healthcare System
state: California
city: San Francisco
country: United States
facility: University Of California, San Francisco/Sf General Hospital
state: California
city: Torrance
country: United States
facility: South Bay Ge Medical Group
state: California
city: Orlando
country: United States
facility: Orlando Va Medical Center
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Tampa
country: United States
facility: Infectious Disease Research Institute, Inc.
state: Florida
city: Marietta
country: United States
facility: Gastrointestinal Specialists Of Georgia Pc
state: Georgia
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Kansas City
country: United States
facility: Saint Luke'S Transplant Specialists
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Tulsa
country: United States
facility: Options Health Research, Llc
state: Oklahoma
city: Tulsa
country: United States
facility: Healthcare Research Consultants
state: Oklahoma
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute
state: Texas
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
city: San Antonio
country: United States
facility: Alamo Medical Research
state: Texas
city: Murray
country: United States
facility: Clinical Research Centers Of America
state: Utah
city: Annandale
country: United States
facility: Metropolitan Research
state: Virginia
city: Newport News
country: United States
facility: Bon Secours St. Mary'S Hospital Of Richmond, Inc.
state: Virginia
city: Norfolk
country: United States
facility: Digestive And Liver Disease Specialists
state: Virginia
city: Graz
country: Austria
facility: Local Institution
city: Linz
country: Austria
facility: Local Institution
city: Bruxelles
country: Belgium
facility: Local Institution
city: Edegem
country: Belgium
facility: Local Institution
city: Leuven
country: Belgium
facility: Local Institution
city: Liege
country: Belgium
facility: Local Institution
city: Salvador
country: Brazil
facility: Local Institution
state: Bahia
city: Salvador
country: Brazil
facility: Local Institution
state: Bahia
city: Curitiba
country: Brazil
facility: Local Institution
state: Parana
city: Curitiba
country: Brazil
facility: Local Institution
state: Parana
city: Porto Alegre
country: Brazil
facility: Local Institution
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Botucatu
country: Brazil
facility: Local Institution
state: SAO Paulo
city: Botucatu
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Rio De Janeiro
country: Brazil
facility: Local Institution
city: Rio De Janeiro
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Calgary
country: Canada
facility: University Of Calgary
state: Alberta
city: Vancouver
country: Canada
facility: Liver And Intestinal Research Centre (Lair)
state: British Columbia
city: Vancouver
country: Canada
facility: Gastrointestinal Research Institute (G.I.R.I.)
state: British Columbia
city: Victoria
country: Canada
facility: Percuro Clinical Research Ltd
state: British Columbia
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Hopital Maisonneuve-Rosemont
state: Quebec
city: Hradec Kralove
country: Czechia
facility: Local Institution
city: Praha 2
country: Czechia
facility: Local Institution
city: Praha 4
country: Czechia
facility: Local Institution
city: Orleans Cedex 2
country: France
facility: Local Institution
city: Poitiers
country: France
facility: Local Institution
city: Rennes Cedex 9
country: France
facility: Local Institution
city: Rouen Cedex
country: France
facility: Local Institution
city: Toulouse Cedex
country: France
facility: Local Institution
city: Villejuif
country: France
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Essen
country: Germany
facility: Local Institution
city: Frankfurt
country: Germany
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: Hannover
country: Germany
facility: Local Institution
city: Muenster
country: Germany
facility: Local Institution
city: Ulm
country: Germany
facility: Local Institution
city: Haifa
country: Israel
facility: Local Institution
city: Haifa
country: Israel
facility: Local Institution
city: Jerusalem
country: Israel
facility: Local Institution
city: Nazareth
country: Israel
facility: Local Institution
city: Ramat Gan
country: Israel
facility: Local Institution
city: Bergamo
country: Italy
facility: Local Institution
city: Cisanello (pisa)
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Torino
country: Italy
facility: Local Institution
city: Bialystok
country: Poland
facility: Local Institution
city: Kielce
country: Poland
facility: Local Institution
city: Lancut
country: Poland
facility: Local Institution
city: Myslowice
country: Poland
facility: Local Institution
city: Raciborz
country: Poland
facility: Local Institution
city: Wroclaw
country: Poland
facility: Local Institution
city: Kazan
country: Russian Federation
facility: Local Institution
state: Republic OF Tatarstan
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: 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: St-petersburg
country: Russian Federation
facility: Local Institution
city: Stavropol
country: Russian Federation
facility: Local Institution
city: A Coruna
country: Spain
facility: Local Institution
city: Alicante
country: Spain
facility: Local Institution
city: San Sebastian
country: Spain
facility: Local Institution
city: Santiago De Compostela
country: Spain
facility: Local Institution
city: Sevilla
country: Spain
facility: Local Institution
city: Sevilla
country: Spain
facility: Local Institution
city: Basel
country: Switzerland
facility: Local Institution
city: Zurich
country: Switzerland
facility: Local Institution
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:
citation: Heim MH. 25 years of interferon-based treatment of chronic hepatitis C: an epoch coming to an end. Nat Rev Immunol. 2013 Jul;13(7):535-42. doi: 10.1038/nri3463. Epub 2013 Jun 7.