Clinical trial NCT00087568: 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
Official title: 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
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: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Pegasys and Ribavirin Therapy Completers
timeFrame: 36 weeks for Non-Tolerators and 60 weeks for Non-Responders
Secondary outcomes:
measure: Number of Participants With >=2-log10 Decrease or Undetectable (<60 International Units Per Milliliter) Hepatitis C Virus-ribonucleic Acid Over Time
timeFrame: Weeks 4, 12, 24, 36, 48, 60, and 84
measure: Number of Participants With Normal Serum Alanine Transaminase Levels Over Time
timeFrame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, and 84
measure: Number of Participants With Serious Adverse Events and Adverse Events
timeFrame: Up to Week 84
measure: Mean Score of Beck Depression Inventory Over Time
timeFrame: Baseline (Week 0); Weeks 4, 12, 24, 36, 48, 60, and 84
measure: Mean Score of Fatigue Severity Over Time
timeFrame: Baseline (Week 0); Weeks 4, 12, 24, 36, 48, 60, and 84
measure: Number of Participants With Individual Flu-like Symptom
timeFrame: Baseline (Week 0); Weeks 12, 36, 60 and 84
measure: Number of Participants With Marked Laboratory Abnormalities
timeFrame: Up to Week 84
measure: Number of Participants With Abnormal Vital Signs
timeFrame: From screening (Day -21 to Day -1) to Week 84
measure: Mean Score for Overall Local Injection Site Reaction
timeFrame: Baseline (Week 0), Week 4, 12, 24, 36, 48 and 60
Other outcomes:
Locations:
city: Bakersfield
country: United States
state: California
city: Pasadena
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Mateo
country: United States
state: California
city: Bradenton
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Austell
country: United States
state: Georgia
city: Annapolis
country: United States
state: Maryland
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Kansas City
country: United States
state: Missouri
city: Bayside
country: United States
state: New York
city: Brooklyn
country: United States
state: New York
city: Manhasset
country: United States
state: New York
city: New York
country: United States
state: New York
city: Valhalla
country: United States
state: New York
city: Statesville
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Knoxville
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Fairfax
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Tacoma
country: United States
state: Washington
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Rustgi 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.