Clinical trial NCT00087607: Peak Study - A Study of Pegasys (Peginterferon Alfa-2a (40KD)) in Combination With Copegus (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C (CHC).
Official title: A Prospective, Randomized, Open-label Study Evaluating the Viral Kinetics and Pharmacokinetics of Pegasys® Plus Copegus® and PEG-Intron® Plus Rebetol® in Interferon-naïve Patients With Chronic Hepatitis C.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2004-07-14
Enrollment: 385
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine the viral kinetics and pharmacokinetics of Pegasys plus ribavirin and PEG-Intron plus ribavirin in interferon-naive patients with CHC. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients at least 18 years of age
* CHC infection, genotype 1
* use of 2 forms of contraception during study in both men and women

Exclusion Criteria:

* previous systemic therapy with anti-viral, anti-neoplastic, or immunomodulatory agents
* medical condition associated with chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposure)
* decompensated liver disease
* women who are pregnant or breastfeeding

Primary outcomes:
measure: Change From Baseline in Viral Load (log10 Reduction) at Week 12
timeFrame: From Baseline to Week 12
Secondary outcomes:
measure: Mean Change From Baseline in Viral Load (log10 Reduction) at Week 4 and Week 8
timeFrame: Baseline, Week 4 and Week 8
measure: Weekly Viral Load Assessed at Drug Trough
timeFrame: Baseline, up to Week 12
measure: The Area Under the HCV-RNA Curve Estimated From the Two Adjacent Pre-dose Assessments at Each Week
timeFrame: From Week -1 to Week 12
measure: Mean Value of Area Under the HCV-RNA Curve Minus Baseline From Week 1 to Week 12
timeFrame: Baseline, Week 1 to Week 12
measure: Cumulative Viral Absolute Area Under the HCV RNA Curve Minus Baseline Averaged Over the 12-week Period
timeFrame: Up to Week 12
measure: Weekly Viral Absolute Area Under the HCV RNA Curve Estimated in the Frequent-sampling Cohort for Weeks 1 and 8
timeFrame: Week 1 and Week 8
measure: Percentage of Participants With a ≥ 2-log10 Decrease or Undetectable (< 60 International Units Per Milliliter) HCV RNA at Each Visit
timeFrame: From Week 1 to Week 12
measure: Percentage of Participants With Undetectable HCV RNA (< 60 International Units/Milliliter) at Each Visit
timeFrame: From Week 1 to Week 12
measure: Number of Participants With Marked Hematologic Abnormalities
timeFrame: Baseline, up to Week 12
measure: Number of Participants With Marked Biochemical Test Abnormalities
timeFrame: Baseline, up to Week 12
measure: Number of Participants With Marked Abnormalities in Thyroid Function Tests
timeFrame: Baseline, up to Week 12
measure: Mean Trough Interferon Concentrations at Each Week
timeFrame: From Week 1 to Week 12
measure: Area Under the Curve for Interferon in the Frequent-Sampling Cohort
timeFrame: Week 1 and Week 8
measure: Number of Participants With Adverse Events and Serious Adverse Events
timeFrame: Up to Week 12
measure: Percentage of Participants With Each of the Identified HCV Quasispecies at Baseline and Weeks 1, 4, 8, and 12
timeFrame: Baseline, Weeks 1, 4,8, and 12
measure: Weekly AUC for IFN Concentrations for Pegasys and PEG-Intron Estimated by Population Pharmacokinetic Modeling
timeFrame: Up to Week 8
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Little Rock
country: United States
state: Arkansas
city: Sacramento
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 Mateo
country: United States
state: California
city: San Rafael
country: United States
state: California
city: Farmington
country: United States
state: Connecticut
city: Hartford
country: United States
state: Connecticut
city: Bradenton
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Wellington
country: United States
state: Florida
city: Kansas City
country: United States
state: Kansas
city: New Orleans
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Burlington
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Kansas City
country: United States
state: Missouri
city: St Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: East Orange
country: United States
state: New Jersey
city: Egg Harbour Township
country: United States
state: New Jersey
city: Vineland
country: United States
state: New Jersey
city: Bronx
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Poughkeepsie
country: United States
state: New York
city: Fayetteville
country: United States
state: North Carolina
city: Statesville
country: United States
state: North Carolina
city: Portland
country: United States
state: Oregon
city: Columbia
country: United States
state: South Carolina
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Fairfax
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Roanoke
country: United States
state: Virginia
city: Tacoma
country: United States
state: Washington
city: Racine
country: United States
state: Wisconsin
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Chung RT, Poordad FF, Hassanein T, Zhou X, Lentz E, Prabhakar A, Di Bisceglie AM. Association of host pharmacodynamic effects with virologic response to pegylated interferon alfa-2a/ribavirin in chronic hepatitis C. Hepatology. 2010 Dec;52(6):1906-14. doi: 10.1002/hep.23947. Epub 2010 Nov 9.
citation: Di Bisceglie AM, Ghalib RH, Hamzeh FM, Rustgi VK. Early virologic response after peginterferon alpha-2a plus ribavirin or peginterferon alpha-2b plus ribavirin treatment in patients with chronic hepatitis C. J Viral Hepat. 2007 Oct;14(10):721-9. doi: 10.1111/j.1365-2893.2007.00862.x.