Clinical trial NCT01087944: A Study of Administration of Peginterferon Alfa-2a [Pegasys] by Autoinjector Versus Pre-filled Syringe in Patients With Chronic Hepatitis C
Official title: Tolerability and User Handling Study of an Autoinjector to Administer 180 µg/0.5 mL Peginterferon Alfa-2a (Pegasys, PEG-IFN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-03-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This randomized, cross-over, open label study will compare the tolerability and handling of application of peginterferon alfa-2a \[Pegasys\] by autoinjector versus pre-filled syringe in patients with chronic hepatitis C, either on treatment with peginterferon alfa-2a for at least 12 weeks or treatment-naïve for peginterferon alfa-2a. Patients will be randomized to self-injection of 180mcg peginterferon alfa-2a once a week using either an autoinjector or a prefilled syringe for 3 weeks, then switch to use the other method of injection for another 3 weeks. Anticipated time on study treatment is 6 weeks. Target sample size is \<100 patients.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>/=18 years of age
* chronic hepatitis C
* on treatment with peginterferon alfa-2a for \>/= 12 weeks at baseline, or treatment-naïve for peginterferon alfa-2a

Exclusion Criteria:

* history or evidence of decompensated liver disease
* autoimmune hepatitis
* hypersensitivity to peginterferon alfa-2a or any of its components
* concomitant treatment that requires administration by self-injection, or prior use of an autoinjector

Primary outcomes:
measure: Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
timeFrame: Week 1, Day 1 (Baseline), Week 2 (Day 8 ± 2 days), Week 3 (Day 15 ± 2 days), Week 4 (Day 22 ± 2 days), Week 5 (Day 29 ± 2 days), Week 6 (Day 36 ± 2 days)
Secondary outcomes:
measure: Number of Participants With Marked Laboratory Abnormalities in Hemoglobin, Albumin and Total Protein
timeFrame: Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)
measure: Number of Participants With Marked Laboratory Abnormalities in Hematocrit
timeFrame: Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)
measure: Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil
timeFrame: Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)
measure: Number of Participants With Marked Laboratory Abnormalities in Right Blood Cell (RBC)
timeFrame: Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)
measure: Number of Participants With Marked Laboratory Abnormalities in Prothrombin Time (PT) International Normalized Ratio (INR)
timeFrame: Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)
measure: Number of Participants With Marked Laboratory Abnormalities in Serum Glutamic Oxaloacetic Transaminase (SGOT), Serum Glutamic-Pyruvic Transaminase (SGPT), and Alkaline Phosphatase
timeFrame: Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)
measure: Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose
timeFrame: Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)
measure: Number of Participants With Marked Laboratory Abnormalities in Creatinine
timeFrame: Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)
measure: Number of Participants With Abnormalities in Pulse Rate, Temperature, and Blood Pressure
timeFrame: Week 1, Day 1 (Baseline), Week 2 (Day 8 ± 2 days), Week 3 (Day 15 ± 2 days), Week 4 (Day 22 ± 2 days), Week 5 (Day 29 ± 2 days), Week 6 (Day 36 ± 2 days)
measure: Number of Participants With Abnormalities in Electrocardiograms
timeFrame: Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)
measure: Number of Participants With Adverse Events (AE)
timeFrame: Upto Day 36
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Bradenton
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: Framingham
country: United States
state: Massachusetts
city: Newark
country: United States
state: New Jersey
city: Vineland
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Poughkeepsie
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Columbia
country: United States
state: South Carolina
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: