Clinical trial NCT02850289: APPROACH Study: Quality of Life and Outcomes Assessment in Participants With Chronic Hepatitis C (CHC) Treated With Pegylated Interferon (PEG-IFN) Alfa-2a and Ribavirin
Official title: A Prospective Study of Peginterferon Alfa-2a and Ribavirin: Outcomes Assessment in Chronic Hepatitis C Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-07-29
Enrollment: 385
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with hepatitis C, who were to be treated with combination of pegylated interferon (PEG-IFN) alfa-2a and ribavirin (PEGASYS RBV), within 7 days of baseline.

Brief summary: This multi-center, observational study will examine the clinical use and outcomes of pegylated interferon (PEG-IFN) alfa-2a and ribavirin combination (PEGASYS RBV) in participants with chronic hepatitis C (CHC). Study visits will be scheduled for baseline, 12, 24 and 48 weeks after baseline. An additional follow-up visit at week 72 will be required for participants with an HCV genotype other than 2 or 3. Quality of life data will be collected at baseline, and at each follow-up visit.


Eligibility criteria: Inclusion Criteria:

* Eligible for and scheduled to receive treatment with commercially available PEG-IFN alfa-2a and ribavirin combination
* Serologic evidence of chronic hepatitis C (CHC) infection
* Detectable serum hepatitis C virus - ribonucleic acid (HCV-RNA)
* Negative urine or blood pregnancy test
* Fertile participants receiving treatment to use two forms of effective contraception during treatment and for 6 months after treatment end

Exclusion Criteria:

* Women with ongoing pregnancy or who are breast feeding, or male partners of women who are pregnant
* Received any investigational drug less than or equal to (\</=) 6 weeks prior to enrollment
* Moderate hepatic failure \[Child-Pugh greater than or equal to (\>/=) B\]
* Co-infection with human immunodeficiency virus (HIV) or hepatitis B
* Autoimmune hepatitis
* Known hypersensitivity to alfa interferons, E. coli-derived products, polyethylene glycol, ribavirin and/or any ingredient in the formulation or component of PEG-IFN alfa-2a or ribavirin

Primary outcomes:
measure: Percentage of Participants with Sustained Virologic Response (SVR)
timeFrame: Up to Week 72
Secondary outcomes:
measure: Short Form Health Survey (SF-36) Physical Composite Score
timeFrame: Baseline, Week 12, 24, 48 and 72
measure: Short Form Health Survey (SF-36) Mental Composite Score
timeFrame: Baseline, Week 12, 24, 48 and 72
measure: Percentage of Participants with Adverse Events of Special Interest Leading to Study Medication Discontinuation
timeFrame: Up to Week 72
measure: Percentage of Participants Who Utilized Resources
timeFrame: Baseline, Week 12, 24, 48 and 72
Other outcomes:
Locations:
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Abbotsford
country: Canada
state: British Columbia
city: Surrey
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Vernon
country: Canada
state: British Columbia
city: West Vancouver
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Barrie
country: Canada
state: Ontario
city: Brampton
country: Canada
state: Ontario
city: Downsview
country: Canada
state: Ontario
city: Hamilton
country: Canada
state: Ontario
city: Kingston
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Mississauga
country: Canada
state: Ontario
city: Newmarket
country: Canada
state: Ontario
city: Oshawa
country: Canada
state: Ontario
city: Oshawa
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Richmond Hill
country: Canada
state: Ontario
city: Richmond Hill
country: Canada
state: Ontario
city: Sudbury
country: Canada
state: Ontario
city: Thunder Bay
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Quebec City
country: Canada
state: Quebec
city: Quebec City
country: Canada
state: Quebec
city: Quebec City
country: Canada
state: Quebec
city: Quebec City
country: Canada
state: Quebec
city: St-charles Borromee
country: Canada
state: Quebec
city: Regina
country: Canada
state: Saskatchewan
city: Saskatoon
country: Canada
state: Saskatchewan
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: