Peak Study - A Study of Pegasys (Peginterferon Alfa-2a (40KD)) in Combination With Copegus (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C (CHC).
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.
1 other identifier
interventional
385
1 country
41
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2004
Typical duration for phase_4
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 12, 2004
CompletedFirst Posted
Study publicly available on registry
July 14, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2006
CompletedResults Posted
Study results publicly available
July 1, 2016
CompletedJuly 1, 2016
May 1, 2016
2.2 years
July 12, 2004
April 5, 2016
May 24, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Viral Load (log10 Reduction) at Week 12
The viral load was determined quantitatively and qualitatively by Hepatitis C virus (HCV)-polymerase chain reaction (PCR). HCV RNA was measured qualitatively using the Roche amplicor PCR assay (lower limit of detection 60 international units per milliliter (U/mL), changed from 50 IU/mL with amendment B) and quantitatively using the Roche amplicor HCV monitor® test v2.0 (lower limit of quantification 600 IU/mL). Log transformations were performed for HCV RNA, and the analyses were done on a log10 scale. The average value of the difference between viral load levels in the serum from baseline to Week 12, expressed in terms of a logarithmic scale with base 10, are presented.
From Baseline to Week 12
Secondary Outcomes (16)
Mean Change From Baseline in Viral Load (log10 Reduction) at Week 4 and Week 8
Baseline, Week 4 and Week 8
Weekly Viral Load Assessed at Drug Trough
Baseline, up to Week 12
The Area Under the HCV-RNA Curve Estimated From the Two Adjacent Pre-dose Assessments at Each Week
From Week -1 to Week 12
Mean Value of Area Under the HCV-RNA Curve Minus Baseline From Week 1 to Week 12
Baseline, Week 1 to Week 12
Cumulative Viral Absolute Area Under the HCV RNA Curve Minus Baseline Averaged Over the 12-week Period
Up to Week 12
- +11 more secondary outcomes
Study Arms (2)
Peginterferon Alfa-2a + Ribavirin
EXPERIMENTALParticipants received Peginterferon alfa-2a (40 kD) \[Pegasys\] at a dosage of 180 microgram (μg), subcutaneously (SC), once a week plus Ribavirin \[Copegus\] 1000 or 1200 milligram (mg)/day), orally, \[according to body weight, lesser than or greater than/equal to (\< or \>/=) 75 kilogram (kg), respectively\] twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (\< or \>/=75 kg body weight, respectively twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
Peginterferon Alfa-2b + Ribavirin
ACTIVE COMPARATORParticipants received Peginterferon alfa-2b (12 kD) \[PEG-Intron\] at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin \[Rebetol\] 1000 or 1200 mg/day orally (\< or \>/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (\< or \>/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
Unknown Facility
Birmingham, Alabama, 35295-0005, United States
Unknown Facility
Little Rock, Arkansas, 72205, United States
Unknown Facility
Sacramento, California, 95817, United States
Unknown Facility
San Diego, California, 92103, United States
Unknown Facility
San Diego, California, 92123, United States
Unknown Facility
San Francisco, California, 94143, United States
Unknown Facility
San Mateo, California, 94403, United States
Unknown Facility
San Rafael, California, 94901, United States
Unknown Facility
Farmington, Connecticut, 06030, United States
Unknown Facility
Hartford, Connecticut, 06015, United States
Unknown Facility
Bradenton, Florida, 34209, United States
Unknown Facility
Miami, Florida, 33125, United States
Unknown Facility
Wellington, Florida, 33414, United States
Unknown Facility
Kansas City, Kansas, 66160, United States
Unknown Facility
New Orleans, Louisiana, 70115, United States
Unknown Facility
Baltimore, Maryland, 21205, United States
Unknown Facility
Boston, Massachusetts, 02215, United States
Unknown Facility
Burlington, Massachusetts, 01805, United States
Unknown Facility
Detroit, Michigan, 48201, United States
Unknown Facility
Kansas City, Missouri, 64131, United States
Unknown Facility
St Louis, Missouri, 63104, United States
Unknown Facility
Omaha, Nebraska, 68198, United States
Unknown Facility
Las Vegas, Nevada, 89128, United States
Unknown Facility
East Orange, New Jersey, 07018, United States
Unknown Facility
Egg Harbour Township, New Jersey, 08234, United States
Unknown Facility
Vineland, New Jersey, 08360, United States
Unknown Facility
New York, New York, 10016, United States
Unknown Facility
New York, New York, 10021, United States
Unknown Facility
Poughkeepsie, New York, 12601, United States
Unknown Facility
The Bronx, New York, 10467, United States
Unknown Facility
Fayetteville, North Carolina, 28304, United States
Unknown Facility
Statesville, North Carolina, 28677, United States
Unknown Facility
Portland, Oregon, 97239, United States
Unknown Facility
Columbia, South Carolina, 29204, United States
Unknown Facility
Austin, Texas, 78758, United States
Unknown Facility
Dallas, Texas, 75203, United States
Unknown Facility
Fairfax, Virginia, 22031, United States
Unknown Facility
Norfolk, Virginia, 23502, United States
Unknown Facility
Roanoke, Virginia, 24016, United States
Unknown Facility
Tacoma, Washington, 98405, United States
Unknown Facility
Racine, Wisconsin, 53405, United States
Related Publications (2)
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.
PMID: 21064034DERIVEDDi 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.
PMID: 17875007DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Roche Trial Information Hotline
- Organization
- F. Hoffmann-La Roche AG
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2004
First Posted
July 14, 2004
Study Start
January 1, 2004
Primary Completion
March 1, 2006
Study Completion
April 1, 2006
Last Updated
July 1, 2016
Results First Posted
July 1, 2016
Record last verified: 2016-05