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

Hepatitis C, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02850289
• Other study ID #: ML20090
• Status: Completed
• Phase: N/A
• First received: July 28, 2016
• Last updated: October 2, 2017
• Start date: April 2006
• Est. completion date: October 2008

Study information

• Verified date: October 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 385
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Sustained Virologic Response (SVR)		Up to Week 72
Secondary	Short Form Health Survey (SF-36) Physical Composite Score		Baseline, Week 12, 24, 48 and 72
Secondary	Short Form Health Survey (SF-36) Mental Composite Score		Baseline, Week 12, 24, 48 and 72
Secondary	Percentage of Participants with Adverse Events of Special Interest Leading to Study Medication Discontinuation		Up to Week 72
Secondary	Percentage of Participants Who Utilized Resources		Baseline, Week 12, 24, 48 and 72