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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.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02850289
First received: July 28, 2016
Last updated: NA
Last verified: July 2016
History: No changes posted
  Purpose
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

  Eligibility

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.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02850289

  Show 46 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov 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
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
Interferons
Ribavirin
Peginterferon alfa-2a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2016