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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01754974
Other study ID # AI452-033
Secondary ID 2012-003508-11
Status Completed
Phase Phase 3
First received December 19, 2012
Last updated January 27, 2015
Start date March 2013
Est. completion date September 2014

Study information

Verified date December 2013
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug AdministrationBrazil: National Health Surveillance AgencyBrazil: Ministry of HealthBrazil: National Committee of Ethics in ResearchCzech Republic: State Institute for Drug ControlHungary: National Institute of PharmacyMexico: Ministry of HealthPoland: 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 AgencyRussia: Ethics CommitteeRussia: Ministry of Health of the Russian FederationRussia: FSI Scientific Center of Expertise of Medical ApplicationTurkey: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine if 48 weeks of therapy with Peginterferon Lambda plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC) compared to therapy with Peginterferon alfa-2a plus Ribavirin.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Chronic hepatitis C, Genotype 1

- HCV RNA =100,000 IU/mL at screening

- Liver biopsy documenting no cirrhosis (within prior 3 years). Where approved for staging of liver disease, non-invasive imaging may be used to assess the extent of liver disease

- Naïve to prior anti-HCV therapy

Exclusion Criteria:

- Infected with HCV other than Genotype 1

- Positive Hepatitis B Surface Antigen (HBsAg), or Human Immunodeficiency Virus (HIV)-1/HIV-2 antibody 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 history of 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


Intervention

Biological:
Peginterferon Lambda-1a

Drug:
Ribavirin

Biological:
Peginterferon alfa-2a


Locations

Country Name City State
Czech Republic Local Institution Hradec Kralove
Czech Republic Local Institution Praha 4
Czech Republic Local Institution Usti Nad Labem
Korea, Republic of Local Institution Chungcheongnam-do
Korea, Republic of Local Institution Daegu
Korea, Republic of Local Institution Gangwon-do
Korea, Republic of Local Institution Gyeonggi-do
Korea, Republic of Local Institution Gyeonggi-do
Korea, Republic of Local Institution Gyeongsangnam-do
Korea, Republic of Local Institution Incheon
Korea, Republic of Local Institution Seoul
Mexico Local Institution Distrito Federal
Mexico Local Institution Guadalajara Jalisco
Mexico Local Institution Guadalajara Jalisco
Mexico Local Institution Mexico Distrito Federal
Mexico Local Institution Mexico City Estado De Mexico

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Czech Republic,  Korea, Republic of,  Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of subjects who develop treatment emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, and/or neutropenia as defined by ANC < 750 mm3 and/or thrombocytopenia as defined by platelets < 50,000 mm3) in treatment-naive subjects ANC = Absolute Neutrophil Count
Hb = Hemoglobin
Up to 48 weeks of treatment Yes
Secondary Proportion of subjects with Sustained Virologic Response at Post-Treatment Follow-up Week 24 (SVR24), defined as Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < Lower Limit of Quantitation of Assay (LLOQ) At Post-Treatment Follow-up Week 24 No
Secondary Proportion of subjects with Rapid Virologic Response (RVR) (HCV RNA not detected) On treatment Week 4 (of an up to 48-week treatment period) No
Secondary Proportion of subjects with on-treatment Serious Adverse Events (SAEs) through end of treatment Up to 48 weeks of treatment Yes
Secondary Proportion of subjects with dose reductions through end of treatment Up to 48 weeks of treatment Yes
Secondary Proportion of subjects who discontinue due to Adverse Events (AEs) through end of treatment Up to 48 weeks of treatment Yes
Secondary Proportion of subjects with on-treatment Interferon (IFN)-associated symptoms as determined by adverse event reporting On-treatment IFN-associated symptoms are:
Flu-like symptoms (as defined by pyrexia or chills or pain)
Musculoskeletal symptoms (as defined by arthralgia or myalgia or back pain)
Neurological symptoms (headache or dizziness)
Constitutional symptoms (fatigue or asthenia)
Psychiatric symptoms (depression or irritability or insomnia)
Up to 48 weeks of treatment Yes
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