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Completed

NCT Number: 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

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.

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pegylated interferon (PEG-INF) alfa-2a

Drug

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

Ribavirin

Drug

Ribavirin will be administered as per investigator's discretion and will be in line with the current product monograph.

Other names: COPEGUS

Primary outcomes

  1. Percentage of Participants with Sustained Virologic Response (SVR)

    Time frame: Up to Week 72

Secondary outcomes

  1. Short Form Health Survey (SF-36) Physical Composite Score

    Time frame: Baseline, Week 12, 24, 48 and 72

  2. Short Form Health Survey (SF-36) Mental Composite Score

    Time frame: Baseline, Week 12, 24, 48 and 72

  3. Percentage of Participants with Adverse Events of Special Interest Leading to Study Medication Discontinuation

    Time frame: Up to Week 72

  4. Percentage of Participants Who Utilized Resources

    Time frame: Baseline, Week 12, 24, 48 and 72

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jul 29, 2016
Registry last updated
Oct 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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