Quality of Life During Treatment of Chronic Hepatitis C (P05278/MK-4031-336)

NCT ID: NCT00863109

Last Updated: 2017-04-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 133 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2013-05-31

Brief Summary

The primary objective of this study is to evaluate the impact of chronic hepatitis C (CHC), and the treatment thereof with peginterferon alpha-2b (PEG) and ribavirin (RBV) according to standard clinical practice, on the health-related quality of life (HRQL) of a cohort of participants throughout 72 weeks of follow-up. HRQL was assessed using the 36-Item Short-Form Health Survey (SF-36) and the Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV).

Detailed Description

As widely shown in previous reports Hepatitis C Virus (HCV) patients commonly experience fatigue, anxiety, and depression. These symptoms negatively affect patients' functional health, ability to work, self-perceived health, HRQL and well-being. Psychosocial issues and reduced HRQL are frequently experienced by HCV patients. HCV patients have more HRQL impairment than the general population. There is some evidence that HCV patients who experience greater fatigue, greater psychiatric symptoms, and poorer HRQL are more likely to discontinue treatment prematurely, with a negative impact on virological response. In addition to well-known side effects of interferon, one important determinant of HRQL during anti-viral therapy for HCV is development of RBV-induced anemia. Treatment of anemia improves HRQL, potentially impacting adherence to antiviral regimen and improving virologic response. These issues emphasize the importance of investigating the physical and psychosocial experiences and HRQL of HCV patients.

The sample size of the study must allow evaluating HRQL of HCV patients based on the SF-36 before PEG treatment and at each of the following study visits.

To be able to detect differences of or over 4.2 points in the vitality dimension between the basal visit and following visits, estimating a standard deviation of 22 points, a statistical power of 80%, and a level of significance of 0.05, 216 patients will be needed. Considering a loss of follow up of 15%, a total of 238 patients are planned for this study.

Conditions

Hepatitis C, Chronic; Genotype 1; HCV-1

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PEG + RBV (Standard Clinical Practice)

Participants receive peginterferon alfa-2b (PEG) and ribavirin (RBV) in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.

Peginterferon alfa-2b (PEG)

Intervention Type: BIOLOGICAL

Pegylated interferon alfa-2b was administered in accordance with the dosage and pattern prescribed by each participant's physician (standard clinical practice).

Ribavirin (RBV)

Intervention Type: DRUG

Ribavirin was administered in accordance with the dosage and pattern prescribed by each participant's physician (standard clinical practice).

Interventions

Peginterferon alfa-2b (PEG)

Pegylated interferon alfa-2b was administered in accordance with the dosage and pattern prescribed by each participant's physician (standard clinical practice).

Intervention Type: BIOLOGICAL

Ribavirin (RBV)

Ribavirin was administered in accordance with the dosage and pattern prescribed by each participant's physician (standard clinical practice).

Intervention Type: DRUG

Other Intervention Names

PegIntron; SCH 054031; Rebetol; SCH 18908

Eligibility Criteria

Inclusion Criteria

• Participants diagnosed with chronic hepatitis C (CHC)
• Participants with HCV genotype 1
• Participants who, at the time of the study, are referred to the Hospital Pharmacy Service to begin treatment with PEG and RBV for 48 weeks
• Available to understand and to give Informed Consent

Exclusion Criteria

• Participants co-infected with Human Immunodeficiency Virus (HIV) or Hepatitis B Virus (HBV)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

MK-4031-336

Identifier Type: OTHER

Identifier Source: secondary_id

P05278

Identifier Type: -

Identifier Source: org_study_id