Clinical trial NCT00107653: Latino Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) in Treatment-Naive Patients With Chronic Hepatitis C-Genotype 1.
Official title: A Prospective, Multicenter, Open-label, Comparative, Efficacy Study of Pegasys® Plus Copegus® in Treatment-naïve Latino Patients With Chronic Hepatitis C-genotype 1, as Compared to Treatment-naïve Non- Latino Caucasian Patients With Chronic Hepatitis C-genotype 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2005-04-07
Enrollment: 569
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will evaluate the efficacy and safety of PEGASYS (180 micrograms sc weekly) plus ribavirin (1000-1200mg po daily) in treatment-naive Latino patients versus non-Latino Caucasian patients with chronic hepatitis C- genotype 1. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ patients.


Eligibility criteria: Inclusion Criteria:

* adult patients 18-65 years of age
* chronic hepatitis C , genotype 1
* serologic evidence of CHC infection by an antibody test
* chronic liver disease, consistent with CHC infection on a liver biopsy obtained within the past 18 months
* compensated liver disease
* use of 2 forms of contraception during the study in both men and women

Exclusion Criteria:

* previous interferon or ribavirin therapy
* systemic antiviral therapy less than 24 weeks before first dose of study drug or expected need for this treatment any time during the study
* medical condition associated with chronic liver disease (eg, hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure)
* decompensated liver disease
* women who are pregnant or breastfeeding

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response at Week 72
timeFrame: At Week 72
Secondary outcomes:
measure: Percentage of Participants Achieving Virologic Response
timeFrame: At Weeks 4, 12, 24, 48, 60, and 72
measure: Percentage of Participants With Early Virologic Response at Week 4
timeFrame: At Week 4
measure: Percentage of Participants With Early Virologic Response at Week 12
timeFrame: At Week 12
measure: Change From Baseline in HCV-RNA Log10 Titers Over the Period Of Time
timeFrame: From Baseline (Week 0) to Weeks 4, 12, 24, 48, 60 and 72
measure: Percentage of Participants With Biochemical Response
timeFrame: At Weeks 4, 12, 24, 48, 60 and 72
measure: Percentage of Participants With ISHAK Histological Activity Index Response
timeFrame: At Week 72
measure: Mean Change From Baseline in ISHAK HAI Activity (Necroinflammatory) at Week 72
timeFrame: From Baseline (Week 0) to Week 72
measure: Mean Change From Baseline in Fibrosis Score Based on ISHAK at Week 72
timeFrame: From Baseline (Week 0) to Week 72
measure: Percentage of Participants With Improved, Stable and Worsened ISHAK Fibrosis Score
timeFrame: At Week 72
measure: Mean Change From Baseline in Activity and Fibrosis Scores Based on METAVIR Activity at Week 72
timeFrame: From Baseline (Week 0) to Week 72
measure: Percentage of Participants With Improved, Stable, and Worsened METAVIR Activity Score
timeFrame: At Week 72
measure: Percentage of Participants With Improved, Stable, and Worsened METAVIR Fibrosis Score
timeFrame: At Week 72
measure: Mean Change From Baseline in Fat Score at Week 72
timeFrame: From Baseline (Week 0) to Week 72
measure: Percentage of Participants With Improved, Stable and Worsened Fat Score From Baseline to Week 72
timeFrame: From Baseline (Week 0) to Week 72
measure: Percentage of Participants With Non-zero Nonalcoholic Steatohepatitis Score
timeFrame: At Week 72
measure: Mean Change in Fatigue Severity Scale Score and Fatigue Severity Scale Score Item 10 Visual Analog Scale Score From Baseline at Week 48 and Week 72
timeFrame: Baseline (Week 0), Week 48 and Week 72
measure: Mean Change in 36-item Short Form Health Survey Total and Domain Scores From Baseline at Week 48 and 72
timeFrame: Baseline (Week 0), Week 48 and Week 72
measure: Number of Participants With Any Adverse Events and Serious Adverse Events
timeFrame: Up to Week 72
measure: Number of Participants With Marked Abnormal Laboratory Parameters
timeFrame: Up to Week 72
measure: Number of Participants With Premature Withdrawals Due to Adverse Events or Laboratory Abnormalities
timeFrame: Up to Week 72
Other outcomes:
Locations:
city: Scottsdale
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Anaheim
country: United States
state: California
city: Fountain Valley
country: United States
state: California
city: Fresno
country: United States
state: California
city: Lancaster
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Palo Alto
country: United States
state: California
city: Redlands
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Bernardino
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: San Luis Obispo
country: United States
state: California
city: Ventura
country: United States
state: California
city: Pueblo
country: United States
state: Colorado
city: Boca Raton
country: United States
state: Florida
city: Bradenton
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: North Miami Beach
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: Austell
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Gurnee
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Baton Rouge
country: United States
state: Louisiana
city: New Orleans
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Framingham
country: United States
state: Massachusetts
city: Worcester
country: United States
state: Massachusetts
city: St Louis
country: United States
state: Missouri
city: Vineland
country: United States
state: New Jersey
city: Bayside
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Fayetteville
country: United States
state: North Carolina
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Fort Sam Houston
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Galveston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Fairfax
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Ponce
country: Puerto Rico
city: Santurce
country: Puerto Rico
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Rodriguez-Torres M, Jeffers LJ, Sheikh MY, Rossaro L, Ankoma-Sey V, Hamzeh FM, Martin P; Latino Study Group. Peginterferon alfa-2a and ribavirin in Latino and non-Latino whites with hepatitis C. N Engl J Med. 2009 Jan 15;360(3):257-67. doi: 10.1056/NEJMoa0805062.