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
A Prospective Study of Peginterferon Alfa-2a and Ribavirin: Outcomes Assessment in Chronic Hepatitis C Patients
1 other identifier
observational
385
1 country
46
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2006
Typical duration for all trials
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 28, 2016
CompletedFirst Posted
Study publicly available on registry
July 29, 2016
CompletedOctober 3, 2017
October 1, 2017
2.5 years
July 28, 2016
October 2, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants with Sustained Virologic Response (SVR)
Up to Week 72
Secondary Outcomes (4)
Short Form Health Survey (SF-36) Physical Composite Score
Baseline, Week 12, 24, 48 and 72
Short Form Health Survey (SF-36) Mental Composite Score
Baseline, Week 12, 24, 48 and 72
Percentage of Participants with Adverse Events of Special Interest Leading to Study Medication Discontinuation
Up to Week 72
Percentage of Participants Who Utilized Resources
Baseline, Week 12, 24, 48 and 72
Study Arms (1)
Pegylated Interferon (PEG-IFN) alfa-2a and Ribavirin
Participants with hepatitis C who were to be treated with combination of pegylated interferon (PEG-IFN) alfa-2a and ribavirin, within 7 days of baseline, with ongoing management at investigator's discretion.
Interventions
Pegylated interferon (PEG-IFN) alfa-2a will be administered as per investigator's discretion and will be in line with the current product monograph.
Ribavirin will be administered as per investigator's discretion and will be in line with the current product monograph.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (46)
Unknown Facility
Calgary, Alberta, T2N 4N1, Canada
Unknown Facility
Edmonton, Alberta, T5H 4B9, Canada
Unknown Facility
Edmonton, Alberta, T6G 2C8, Canada
Unknown Facility
Edmonton, Alberta, T6G2B7, Canada
Unknown Facility
Abbotsford, British Columbia, V2S 3N5, Canada
Unknown Facility
Surrey, British Columbia, V3V 1Z1, Canada
Unknown Facility
Vancouver, British Columbia, V5Z 1H2, Canada
Unknown Facility
Vancouver, British Columbia, V5Z 3P1, Canada
Unknown Facility
Vancouver, British Columbia, V6Z 2C7, Canada
Unknown Facility
Vancouver, British Columbia, V6Z 2K5, Canada
Unknown Facility
Vernon, British Columbia, V1T 1W9, Canada
Unknown Facility
West Vancouver, British Columbia, V7S 1X1, Canada
Unknown Facility
Winnipeg, Manitoba, R2W 5L4, Canada
Unknown Facility
Barrie, Ontario, L4M 5G1, Canada
Unknown Facility
Brampton, Ontario, L6V 1B4, Canada
Unknown Facility
Downsview, Ontario, M3N 2V7, Canada
Unknown Facility
Greater Sudbury, Ontario, P3E 1B8, Canada
Unknown Facility
Hamilton, Ontario, L8L 2X2, Canada
Unknown Facility
Kingston, Ontario, K7L 5G2, Canada
Unknown Facility
London, Ontario, N6A 5A5, Canada
Unknown Facility
London, Ontario, N6A 5R9, Canada
Unknown Facility
London, Ontario, N6B 2L4, Canada
Unknown Facility
Mississauga, Ontario, L5M 2V8, Canada
Unknown Facility
Newmarket, Ontario, L3Y 2P6, Canada
Unknown Facility
Oshawa, Ontario, L1G 2B9, Canada
Unknown Facility
Oshawa, Ontario, L1J 2J9, Canada
Unknown Facility
Ottawa, Ontario, K1H 8L6, Canada
Unknown Facility
Ottawa, Ontario, K1Y 4E9, Canada
Unknown Facility
Richmond Hill, Ontario, L4E 4L6, Canada
Unknown Facility
Richmond Hill, Ontario, Canada
Unknown Facility
Thunder Bay, Ontario, P7B 6V4, Canada
Unknown Facility
Toronto, Ontario, M5G 2C4, Canada
Unknown Facility
Toronto, Ontario, M6H 3M1, Canada
Unknown Facility
Windsor, Ontario, N8X 5A6, Canada
Unknown Facility
Windsor, Ontario, N9A 1C9, Canada
Unknown Facility
Montreal, Quebec, H1T 2M4, Canada
Unknown Facility
Montreal, Quebec, H3A 1A1, Canada
Unknown Facility
Montreal, Quebec, H4J 1C5, Canada
Unknown Facility
Montreal, Quebec, J2X 4S7, Canada
Unknown Facility
Québec, Quebec, G1L 3L5, Canada
Unknown Facility
Québec, Quebec, G1R 1S9, Canada
Unknown Facility
Québec, Quebec, G1R 2J6, Canada
Unknown Facility
Québec, Quebec, QC G1S 4L8, Canada
Unknown Facility
Saint-Charles-Borromée, Quebec, J6E 2C3, Canada
Unknown Facility
Regina, Saskatchewan, S4P 4V6, Canada
Unknown Facility
Saskatoon, Saskatchewan, S7N 0W8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2016
First Posted
July 29, 2016
Study Start
April 1, 2006
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
October 3, 2017
Record last verified: 2017-10