Clinical trial NCT01754974: Safety and Efficacy Study of Peginterferon Lambda-1a vs. Peginterferon Alfa-2a, Plus Ribavirin in Subjects With Genotype 1 Hepatitis C
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C Virus (HCV)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2012-12-21
Enrollment: 40
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 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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Up to 48 weeks of treatment
Secondary outcomes:
measure: 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)
timeFrame: At Post-Treatment Follow-up Week 24
measure: Proportion of subjects with Rapid Virologic Response (RVR) (HCV RNA not detected)
timeFrame: On treatment Week 4 (of an up to 48-week treatment period)
measure: Proportion of subjects with on-treatment Serious Adverse Events (SAEs) through end of treatment
timeFrame: Up to 48 weeks of treatment
measure: Proportion of subjects with dose reductions through end of treatment
timeFrame: Up to 48 weeks of treatment
measure: Proportion of subjects who discontinue due to Adverse Events (AEs) through end of treatment
timeFrame: Up to 48 weeks of treatment
measure: Proportion of subjects with on-treatment Interferon (IFN)-associated symptoms as determined by adverse event reporting
timeFrame: Up to 48 weeks of treatment
Other outcomes:
Locations:
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: Chungcheongnam-do
country: Korea, Republic of
facility: Local Institution
city: Daegu
country: Korea, Republic of
facility: Local Institution
city: Gangwon-do
country: Korea, Republic of
facility: Local Institution
city: Gyeonggi-do
country: Korea, Republic of
facility: Local Institution
city: Gyeonggi-do
country: Korea, Republic of
facility: Local Institution
city: Gyeongsangnam-do
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: Mexico
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Local Institution
state: Estado De Mexico
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Distrito Federal
country: Mexico
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: