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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 study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: July 28, 2016
Last updated: NA
Last verified: July 2016
History: No changes posted
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.

Condition Intervention
Hepatitis C, Chronic
Drug: Pegylated interferon (PEG-INF) alfa-2a
Drug: Ribavirin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study of Peginterferon Alfa-2a and Ribavirin: Outcomes Assessment in Chronic Hepatitis C Patients

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants with Sustained Virologic Response (SVR) [ Time Frame: Up to Week 72 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Short Form Health Survey (SF-36) Physical Composite Score [ Time Frame: Baseline, Week 12, 24, 48 and 72 ] [ Designated as safety issue: No ]
  • Short Form Health Survey (SF-36) Mental Composite Score [ Time Frame: Baseline, Week 12, 24, 48 and 72 ] [ Designated as safety issue: No ]
  • Percentage of Participants with Adverse Events of Special Interest Leading to Study Medication Discontinuation [ Time Frame: Up to Week 72 ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Utilized Resources [ Time Frame: Baseline, Week 12, 24, 48 and 72 ] [ Designated as safety issue: No ]

Enrollment: 385
Study Start Date: March 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: PEGASYS
Drug: Ribavirin
Ribavirin will be administered as per investigator's discretion and will be in line with the current product monograph.
Other Name: COPEGUS


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT02850289

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Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT02850289     History of Changes
Other Study ID Numbers: ML20090 
Study First Received: July 28, 2016
Last Updated: July 28, 2016
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Peginterferon alfa-2a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action processed this record on July 28, 2016