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

Completed

• Conditions: Hepatitis C, Chronic
• Interventions: Drug: Pegylated interferon (PEG-INF) alfa-2a; Drug: Ribavirin

• Registration Number: NCT02850289
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Study First Submitted: 2016-07-28
• Study First Submitted QC: 2016-07-28
• Study First Posted: 2016-07-29
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-02
• Last Update Posted: 2017-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 385

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pegylated Interferon (PEG-IFN) alfa-2a and Ribavirin	Pegylated interferon (PEG-INF) alfa-2a	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.
Pegylated Interferon (PEG-IFN) alfa-2a and Ribavirin	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Sustained Virologic Response (SVR)	Up to Week 72

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Utilized Resources	Baseline, Week 12, 24, 48 and 72
Short Form Health Survey (SF-36) Mental Composite Score	Baseline, Week 12, 24, 48 and 72
Short Form Health Survey (SF-36) Physical 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