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Safety and Efficacy Study of Peginterferon Lambda-1a vs. Peginterferon Alfa-2a, Plus Ribavirin in Subjects With Genotype 1 Hepatitis C

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C Virus (HCV)

Intervention: Peginterferon Lambda-1a (Biological); Ribavirin (Drug); Peginterferon alfa-2a (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

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.

Clinical Details

Official title: A Double-Blinded, Randomized Control Study Evaluating the Efficacy and Safety of Peginterferon Lambda-1a Compared to Peginterferon Alfa-2a, Each in Combination With Ribavirin, in the Treatment of Naive Genotype 1 Chronic Hepatitis C Subjects

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

Primary outcome: 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

Secondary outcome:

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)

Proportion of subjects with Rapid Virologic Response (RVR) (HCV RNA not detected)

Proportion of subjects with on-treatment Serious Adverse Events (SAEs) through end of treatment

Proportion of subjects with dose reductions through end of treatment

Proportion of subjects who discontinue due to Adverse Events (AEs) through end of treatment

Proportion of subjects with on-treatment Interferon (IFN)-associated symptoms as determined by adverse event reporting

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Local Institution, Hradec Kralove 500 05, Czech Republic

Local Institution, Praha 4 140 00, Czech Republic

Local Institution, Usti Nad Labem 400 01, Czech Republic

Local Institution, Chungcheongnam-do 330-930, Korea, Republic of

Local Institution, Daegu 700-821, Korea, Republic of

Local Institution, Gangwon-do 200-704, Korea, Republic of

Local Institution, Gyeonggi-do 420-717, Korea, Republic of

Local Institution, Gyeonggi-do 463-707, Korea, Republic of

Local Institution, Gyeongsangnam-do 626-770, Korea, Republic of

Local Institution, Incheon 403-720, Korea, Republic of

Local Institution, Seoul 156-755, Korea, Republic of

Local Institution, Distrito Federal 03720, Mexico

Local Institution, Mexico, Distrito Federal 07760, Mexico

Local Institution, Mexico City, Estado De Mexico 06700, Mexico

Local Institution, Guadalajara, Jalisco 44500, Mexico

Local Institution, Guadalajara, Jalisco 44650, Mexico

Additional Information

BMS Clinical Trial Information

BMS clinical trial educational resource

Investigator Inquiry form

FDA Safety Alerts and Recalls

Starting date: March 2013
Last updated: January 27, 2015

Page last updated: August 23, 2015

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