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

October 2, 2017 updated by: Hoffmann-La Roche

A Prospective Study of Peginterferon Alfa-2a and Ribavirin: Outcomes Assessment in Chronic Hepatitis C Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

385

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
      • Edmonton, Alberta, Canada, T6G 2C8
      • Edmonton, Alberta, Canada, T5H 4B9
      • Edmonton, Alberta, Canada, T6G2B7
    • British Columbia
      • Abbotsford, British Columbia, Canada, V2S 3N5
      • Surrey, British Columbia, Canada, V3V 1Z1
      • Vancouver, British Columbia, Canada, V5Z 1H2
      • Vancouver, British Columbia, Canada, V5Z 3P1
      • Vancouver, British Columbia, Canada, V6Z 2K5
      • Vancouver, British Columbia, Canada, V6Z 2C7
      • Vernon, British Columbia, Canada, V1T 1W9
      • West Vancouver, British Columbia, Canada, V7S 1X1
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2W 5L4
    • Ontario
      • Barrie, Ontario, Canada, L4M 5G1
      • Brampton, Ontario, Canada, L6V 1B4
      • Downsview, Ontario, Canada, M3N 2V7
      • Hamilton, Ontario, Canada, L8L 2X2
      • Kingston, Ontario, Canada, K7L 5G2
      • London, Ontario, Canada, N6A 5A5
      • London, Ontario, Canada, N6A 5R9
      • London, Ontario, Canada, N6B 2L4
      • Mississauga, Ontario, Canada, L5M 2V8
      • Newmarket, Ontario, Canada, L3Y 2P6
      • Oshawa, Ontario, Canada, L1G 2B9
      • Oshawa, Ontario, Canada, L1J 2J9
      • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa, Ontario, Canada, K1Y 4E9
      • Richmond Hill, Ontario, Canada
      • Richmond Hill, Ontario, Canada, L4E 4L6
      • Sudbury, Ontario, Canada, P3E 1B8
      • Thunder Bay, Ontario, Canada, P7B 6V4
      • Toronto, Ontario, Canada, M5G 2C4
      • Toronto, Ontario, Canada, M6H 3M1
      • Windsor, Ontario, Canada, N8X 5A6
      • Windsor, Ontario, Canada, N9A 1C9
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
      • Montreal, Quebec, Canada, H3A 1A1
      • Montreal, Quebec, Canada, H4J 1C5
      • Montreal, Quebec, Canada, J2X 4S7
      • Quebec City, Quebec, Canada, G1R 2J6
      • Quebec City, Quebec, Canada, G1L 3L5
      • Quebec City, Quebec, Canada, G1R 1S9
      • Quebec City, Quebec, Canada, QC G1S 4L8
      • St-charles Borromee, Quebec, Canada, J6E 2C3
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4P 4V6
      • Saskatoon, Saskatchewan, Canada, S7N 0W8

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Pegylated interferon (PEG-INF) alfa-2a
Pegylated interferon (PEG-IFN) alfa-2a will be administered as per investigator's discretion and will be in line with the current product monograph.
Other Names:
  • PEGASYS
Drug: Ribavirin
Ribavirin will be administered as per investigator's discretion and will be in line with the current product monograph.
Other Names:
  • COPEGUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with Sustained Virologic Response (SVR)
Time Frame: Up to Week 72
Up to Week 72

Secondary Outcome Measures

Outcome Measure
Time Frame
Short Form Health Survey (SF-36) Physical Composite Score
Time Frame: Baseline, Week 12, 24, 48 and 72
Baseline, Week 12, 24, 48 and 72
Short Form Health Survey (SF-36) Mental Composite Score
Time Frame: Baseline, Week 12, 24, 48 and 72
Baseline, Week 12, 24, 48 and 72
Percentage of Participants with Adverse Events of Special Interest Leading to Study Medication Discontinuation
Time Frame: Up to Week 72
Up to Week 72
Percentage of Participants Who Utilized Resources
Time Frame: Baseline, Week 12, 24, 48 and 72
Baseline, Week 12, 24, 48 and 72

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (ACTUAL)

October 1, 2008

Study Completion (ACTUAL)

October 1, 2008

Study Registration Dates

First Submitted

July 28, 2016

First Submitted That Met QC Criteria

July 28, 2016

First Posted (ESTIMATE)

July 29, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 3, 2017

Last Update Submitted That Met QC Criteria

October 2, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML20090

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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