A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Ribavirin in Patients With Chronic Hepatitis C (CHC) Previously Treated With PEG-Intron + Ribavirin
An Open-label, Multicenter, Efficacy and Safety Study of Pegasys® Plus Ribavirin in Patients With Chronic HCV Infection Who Are Unable to Tolerate or Who Do Not Respond to 12 Weeks of Therapy With PEGIntron ® Plus Ribavirin
1 other identifier
interventional
57
1 country
25
Brief Summary
This study will evaluate the efficacy, safety and tolerability of PEGASYS plus ribavirin in patients with CHC who could not tolerate or were not responsive to 12 weeks of therapy with PEG-Intron plus ribavirin. The anticipated time on study treatment is 1-2 years, and the target sample size is \>100 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2003
Typical duration for phase_4
25 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, 2003
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
March 1, 2006
CompletedResults Posted
Study results publicly available
June 8, 2016
CompletedJune 8, 2016
May 1, 2016
3.2 years
July 12, 2004
February 3, 2016
May 2, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Pegasys and Ribavirin Therapy Completers
Therapy completers were defined as all participants who had demonstrable viremia after 12 weeks of Pegasys plus ribavirin therapy (who were to be discontinued for lack of efficacy), non-tolerators who completed 36 weeks of Pegasys plus ribavirin therapy, and non-responders who completed 60 weeks of Pegasys plus ribavirin therapy. Study completers included all participants who completed the planned treatment period (36 weeks for non-tolerators and 60 weeks for non-responders) and the 24-week treatment-free follow-up period and participants in either group who were prematurely discontinued per protocol due to insufficient therapeutic response at Week 12.
36 weeks for Non-Tolerators and 60 weeks for Non-Responders
Secondary Outcomes (9)
Number of Participants With >=2-log10 Decrease or Undetectable (<60 International Units Per Milliliter) Hepatitis C Virus-ribonucleic Acid Over Time
Weeks 4, 12, 24, 36, 48, 60, and 84
Number of Participants With Normal Serum Alanine Transaminase Levels Over Time
Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, and 84
Number of Participants With Serious Adverse Events and Adverse Events
Up to Week 84
Mean Score of Beck Depression Inventory Over Time
Baseline (Week 0); Weeks 4, 12, 24, 36, 48, 60, and 84
Mean Score of Fatigue Severity Over Time
Baseline (Week 0); Weeks 4, 12, 24, 36, 48, 60, and 84
- +4 more secondary outcomes
Study Arms (2)
Non-Responders
EXPERIMENTALParticipants will receive Pegasys 180 micro grams (µg or mcg) subcutaneously (SC) once a week and ribavirin 1000 or 1200 milligrams per day \[(mg/day), \< or \>=75 kilogram (Kg) body weight, respectively\], orally in divided doses for 60 weeks.
Non-Tolerators
EXPERIMENTALParticipants will receive Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (\< or \>=75 kg body weight, respectively) orally in divided doses for 36 weeks.
Interventions
180 micrograms weekly for 36 weeks (non-responders) or 60 weeks (non-tolerators)
Eligibility Criteria
You may qualify if:
- adult patients at least 18 years of age
- CHC infection, genotype 1
- unable to tolerate or not responsive to PEG-Intron + ribavirin therapy after 12 weeks of treatment
- use of 2 forms of contraception during the study in both men and women
You may not qualify if:
- women who are pregnant or breast-feeding
- medical condition associated with chronic liver disease (eg, hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures)
- patients with decompensated cirrhosis
- patients receiving any systemic antiviral therapy or investigational drug, other than PEG-Intron + ribavirin, 24 weeks prior to the first dose of study drug
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Unknown Facility
Bakersfield, California, 93301, United States
Unknown Facility
Pasadena, California, 91105, United States
Unknown Facility
San Diego, California, 92123, United States
Unknown Facility
San Mateo, California, 94403, United States
Unknown Facility
Bradenton, Florida, 34209, United States
Unknown Facility
Miami, Florida, 33136-1051, United States
Unknown Facility
Orlando, Florida, 32806, United States
Unknown Facility
Austell, Georgia, 30106, United States
Unknown Facility
Annapolis, Maryland, 21401, United States
Unknown Facility
Baltimore, Maryland, 21229, United States
Unknown Facility
Boston, Massachusetts, 02114, United States
Unknown Facility
Kansas City, Missouri, 64131, United States
Unknown Facility
Bayside, New York, 11358, United States
Unknown Facility
Brooklyn, New York, 11219, United States
Unknown Facility
Manhasset, New York, 11030, United States
Unknown Facility
New York, New York, 10032, United States
Unknown Facility
Valhalla, New York, 10595, United States
Unknown Facility
Statesville, North Carolina, 28677, United States
Unknown Facility
Cincinnati, Ohio, 45219, United States
Unknown Facility
Knoxville, Tennessee, 37920, United States
Unknown Facility
Memphis, Tennessee, 38120, United States
Unknown Facility
Houston, Texas, 77054, United States
Unknown Facility
Fairfax, Virginia, 22031, United States
Unknown Facility
Richmond, Virginia, 23298, United States
Unknown Facility
Tacoma, Washington, 98405, United States
Related Publications (2)
Bonkovsky HL, Tice AD, Yapp RG, Bodenheimer HC Jr, Monto A, Rossi SJ, Sulkowski MS. Efficacy and safety of peginterferon alfa-2a/ribavirin in methadone maintenance patients: randomized comparison of direct observed therapy and self-administration. Am J Gastroenterol. 2008 Nov;103(11):2757-65. doi: 10.1111/j.1572-0241.2008.02065.x. Epub 2008 Aug 5.
PMID: 18684176DERIVEDRustgi VK, Esposito S, Hamzeh FM, Shiffman ML. Peginterferon alfa-2a/ribavirin in hepatitis C virus patients nontolerant or nonresponsive to peginterferon alfa-2b/ribavirin. Aliment Pharmacol Ther. 2008 Mar 1;27(5):433-40. doi: 10.1111/j.1365-2036.2007.03587.x. Epub 2007 Dec 10.
PMID: 18081737DERIVED
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
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2004
First Posted
July 14, 2004
Study Start
January 1, 2003
Primary Completion
March 1, 2006
Study Completion
March 1, 2006
Last Updated
June 8, 2016
Results First Posted
June 8, 2016
Record last verified: 2016-05