Clinical trial NCT00545233: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus COPEGUS (Ribavirin) With or Without Pioglitazone in Treatment-Naive Patients With Chronic Hepatitis C and Insulin Resistance.
Official title: A Randomized, Open-label Study of the Effect of PEGASYS ® Plus COPEGUS® With or Without Concomitant Pioglitazone (Actos®) on Early Viral Kinetics in Treatment-naive Patients With Chronic Hepatitis C, Genotype-1, and Insulin Resistance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-10-17
Enrollment: 155
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 2 arm study will assess the efficacy and safety of PEGASYS plus COPEGUS, with or without concomitant pioglitazone, on hepatitis C virus titers in treatment-naive patients with genotype 1 chronic hepatitis C, and insulin resistance. Patients will be randomized to receive either a)PEGASYS 180 micrograms/week + Copegus 1000-1600 mg/day (according to body weight) for 48 weeks or b)16 weeks of pioglitazone (30 mg daily for 8 weeks, then 45 mg daily for 8 weeks), followed by PEGASYS 180 micrograms/week + Copegus 1000-1600 mg/day + pioglitazone 45 mg daily for 48 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* chronic hepatitis C, genotype 1;
* insulin resistance.

Exclusion Criteria:

* other forms of liver disease;
* cirrhosis;
* previous treatment for chronic hepatitis C;
* insulin treatment during prior 2 weeks;
* type 1 diabetes.

Primary outcomes:
measure: Change From Initiation of Pegasys Plus Copegus in log10 Hepatitis C Virus Ribonucleic Acid (HCV RNA) Viral Load to Week 12 of Anti-HCV Therapy
timeFrame: Initiation of Pegasys plus Copegus, Week 12 of anti-HCV treatment
Secondary outcomes:
measure: Change From Initiation of Pegasys Plus Copegus in log10 HCV RNA Viral Load to Week 24 and Week 48 of Anti-HCV Therapy
timeFrame: Initiation of Pegasys Plus Copegus, Week 24 and Week 48 of anti-HCV therapy
measure: Percentage of Participants Achieving Virologic Response
timeFrame: Weeks 4, 12, 24, 48, 60, 72
measure: Percentage of Participants With a ≥ 2 log10 Decrease in HCV RNA From Initiation of Pegasys Plus Copegus to Weeks 4, 12, 24, 48, 60, 72
timeFrame: Initiation of Pegasys plus Copegus, Weeks 4, 12, 24, 48, 60, 72
measure: Percentage of Participants With a Virological Relapse at Week 72 (24 Weeks After the End of Anti-HCV Treatment)
timeFrame: Week 72
measure: Percentage of Participants With a Confirmed Virological Breakthrough up to 48 Weeks
timeFrame: Up to 48 Weeks
measure: Percentage of Nonresponders During the 48 Week Anti-HCV Treatment Period
timeFrame: Up to 48 Weeks
measure: Change in Log10 HCV RNA Viral Load at Assessments From Randomization to 16 Weeks of Pioglitazone Pretreatment Run-In Period for the Pioglitazone Arm Only
timeFrame: Randomization (Week-16),Weeks -12, -8, -4 and 0
measure: Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed
timeFrame: Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72
measure: Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed.
timeFrame: Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72
measure: Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed
timeFrame: Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72
measure: Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed
timeFrame: Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72
measure: Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed
timeFrame: Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60, 72
measure: Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed
timeFrame: Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72
measure: Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed
timeFrame: Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72
measure: Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed
timeFrame: Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72
measure: Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed
timeFrame: Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72
measure: Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed
timeFrame: Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72
measure: Change From Baseline in Adiponectin Levels at Each Time Point Assessed
timeFrame: Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72
measure: Change From Baseline in Leptin Levels at Each Time Point Assessed
timeFrame: Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72
measure: Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed
timeFrame: Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72
measure: Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed
timeFrame: Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: Anaheim
country: United States
state: California
city: Fresno
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Loma Linda
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Merced
country: United States
state: California
city: Palo Alto
country: United States
state: California
city: Pasadena
country: United States
state: California
city: San Clemente
country: United States
state: California
city: San Mateo
country: United States
state: California
city: Englewood
country: United States
state: Colorado
city: Littleton
country: United States
state: Colorado
city: Hartford
country: United States
state: Connecticut
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Downers Grove
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Iowa City
country: United States
state: Iowa
city: Louisville
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Portland
country: United States
state: Maine
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: Detroit
country: United States
state: Michigan
city: Duluth
country: United States
state: Minnesota
city: Tupelo
country: United States
state: Mississippi
city: Kansas City
country: United States
state: Missouri
city: St Louis
country: United States
state: Missouri
city: Lebanon
country: United States
state: New Hampshire
city: Egg Harbour Township
country: United States
state: New Jersey
city: Hackensack
country: United States
state: New Jersey
city: Bayside
country: United States
state: New York
city: Manhasset
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: New York
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: West Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Fort Sam Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Lubbock
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Charlottesville
country: United States
state: Virginia
city: Tacoma
country: United States
state: Washington
city: San Juan
country: Puerto Rico
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: