Safety and Efficacy Study of Pegylated Interferon Lambda Versus Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C

Hepatitis C Virus (HCV) Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01447394
• Other study ID #: AI452-013
• Secondary ID: 2011-003748-31
• Status: Withdrawn
• Phase: Phase 3
• First received: October 4, 2011
• Last updated: February 2, 2012
• Start date: March 2012
• Est. completion date: August 2014

Study information

• Verified date: February 2012
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSouth Korea: Korea Food and Drug Administration (KFDA)Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)Singapore: Domain Specific Review BoardsSingapore: Health Sciences AuthorityTaiwan: Department of HealthTaiwan: National Bureau of Controlled DrugsHong Kong: Department of HealthBrazil: National Health Surveillance AgencyBrazil: Ethics CommitteeChile: Instituto de Salud Pública de ChileColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosIndia: Central Drugs Standard Control OrganizationIndia: Indian Council of Medical ResearchIndia: Ministry of HealthIndia: Ministry of Science and TechnologyCzech Republic: State Institute for Drug ControlHungary: National Institute of PharmacyPoland: National Institute of MedicinesPoland: Ministry of HealthPoland: Ministry of Science and Higher EducationPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: National Medicines AgencyRomania: Ministry of Public HealthRussia: Ethics CommitteeRussia: Ministry of Health of the Russian FederationRussia: FSI Scientific Center of Expertise of Medical ApplicationTurkey: Ministry of HealthEgypt: Ministry of Health and PopulationSpain: Spanish Agency of MedicinesIreland: Irish Medicines BoardNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)United Kingdom: Medicines and Healthcare Products Regulatory AgencyGreece: Ethics CommitteeGreece: National Organization of MedicinesIsrael: Israeli Health Ministry Pharmaceutical AdministrationItaly: Ministry of HealthItaly: National Bioethics CommitteeItaly: National Institute of HealthItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthItaly: The Italian Medicines AgencyCanada: Health CanadaUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus (HCV)

Intervention

Biological:
• Pegylated Interferon Lambda
Syringe, Subcutaneous, 180 µg, Once weekly, 48 weeks
• Pegylated Interferon Alfa-2a
Syringe, Subcutaneous, 180 µg, Once weekly, 48 weeks

Drug:
• Ribavirin
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks

Locations

Country	Name	City	State
Canada	Local Institution	Vancouver	British Columbia
Canada	Local Institution	Vaughan	Ontario
China	Local Institution	Hong Kong	Hong Kong
Colombia	Local Institution	Bogota
Colombia	Local Institution	Cali
Colombia	Local Institution	Medellin
Czech Republic	Local Institution	Hradec Kralove
Czech Republic	Local Institution	Praha 4
Czech Republic	Local Institution	Usti Nad Labem
Egypt	Local Institution	Cairo
Egypt	Local Institution	Shebin Elkom	Menoufiya
Hong Kong	Local Institution	Lai Chi Kok
Hong Kong	Local Institution	Tai Po
Hungary	Local Institution	Budapest
Hungary	Local Institution	Budapest
Hungary	Local Institution	Debrecen
Hungary	Local Institution	Miskolc
India	Local Institution	Coimbatore
India	Local Institution	Gurgaon
India	Local Institution	Hyderabad	Andhra Pradesh
India	Local Institution	Ludhiana
India	Local Institution	Nagpur
India	Local Institution	New Delhi
Ireland	Local Institution	Dublin
Ireland	Local Institution	Dublin 8	Dublin
Korea, Republic of	Local Institution	Busan
Korea, Republic of	Local Institution	Busan
Korea, Republic of	Local Institution	Daegu
Korea, Republic of	Local Institution	Incheon
Korea, Republic of	Local Institution	Incheon
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Suwon
Netherlands	Local Institution	Amsterdam
Netherlands	Local Institution	Leiden
Poland	Local Institution	Bialystok
Poland	Local Institution	Bydgoszcz
Poland	Local Institution	Chorzow
Poland	Local Institution	Czeladz
Poland	Local Institution	Kielce
Poland	Local Institution	Krakow
Poland	Local Institution	Lodz
Poland	Local Institution	Lublin
Poland	Local Institution	Olsztyn
Poland	Local Institution	Pulawy
Poland	Local Institution	Raciborz
Poland	Local Institution	Sosnowiec
Poland	Local Institution	Warszawa
Poland	Local Institution	Wroclaw
Poland	Local Institution	Zielona Gora
Romania	Local Institution	Bucharest
Romania	Local Institution	Iasi
Romania	Local Institution	Timisoara
Russian Federation	Local Institution	Ioshkar-Ola	Mari El
Russian Federation	Local Institution	Kaluga
Russian Federation	Local Institution	Lipetsk
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Nizhniy Novgorod
Russian Federation	Local Institution	Poselok Noviy
Russian Federation	Local Institution	Samara
Russian Federation	Local Institution	Saratov
Russian Federation	Local Institution	Smolensk
Russian Federation	Local Institution	Smolensk
Russian Federation	Local Institution	St. Petersburg
Russian Federation	Local Institution	St. Petersburg
Russian Federation	Local Institution	St. Petersburg
Russian Federation	Local Institution	St.Petersburg
Russian Federation	Local Institution	St.Petersburg
Russian Federation	Local Institution	Toliatti
Russian Federation	Local Institution	Volgograd
Singapore	Local Institution	Singapore
Singapore	Local Institution	Singapore
Singapore	Local Institution	Singapore
Singapore	Local Institution	Singapore
Spain	Local Institution	A Coruna
Spain	Local Institution	Barcelona
Spain	Local Institution	Barcelona
Spain	Local Institution	Barcelona
Spain	Local Institution	Madrid
Taiwan	Local Institution	Kaohsiung
Taiwan	Local Institution	Kaohsiung
Taiwan	Local Institution	Taichung
Taiwan	Local Institution	Tainan
Taiwan	Local Institution	Taipei
Taiwan	Local Institution	Taipei
Turkey	Local Institution	Ankara
Turkey	Local Institution	Bornova Izmir
Turkey	Local Institution	Diyarbakir
Turkey	Local Institution	Istanbul
Turkey	Local Institution	Trabzon
United Kingdom	Local Institution	Birmingham	West Midlands
United Kingdom	Local Institution	Edinburgh	Midlothian
United Kingdom	Local Institution	London	Greater London
United States	Local Institution	Houston	Texas
United States	Local Institution	Rochester	New York
United States	Local Institution	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Canada,  China,  Colombia,  Czech Republic,  Egypt,  Hong Kong,  Hungary,  India,  Ireland,  Korea, Republic of,  Netherlands,  Poland,  Romania,  Russian Federation,  Singapore,  Spain,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of Lambda + Ribavirin (RBV) compared to Alfa + RBV in achieving a sustained virological response		At follow-up Week 24 (SVR24) following 48 weeks of treatment	Yes
Primary	The safety of Lambda + RBV compared to Alfa + RBV in reducing cytopenic abnormalities		From Day 1 to end of Week 48 on-treatment	Yes
Secondary	Proportion of interferon-associated symptoms: a) Flu-like symptoms b) Musculoskeletal symptoms c) Neurologic symptoms d) Psychiatric symptoms e) Constitutional symptoms		From Day 1 to end of Week 48 on-treatment	Yes

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form