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

NCT00863109 | Completed Results

• 2 other identifiers: P05278MK-4031-336
• Study Type: observational
• Target: 133
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Hepatitis C, Chronic; Genotype 1; HCV-1

Outcome Measures

Primary Outcomes (2)

• Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores

  SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score; higher scores indicate better health status.

  Baseline, Week 72

• Change From Baseline (BL) to Week 72 (WK72) in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV)

  The CLDQ-HCV is a disease-specific questionnaire measuring HRQL that contains 29 items divided into 4 domains: emotional function (9 items), worry (6 items), systemic symptoms (8 items) and activity/energy (6 items). All items refer to the previous 2 weeks and are rated on a 7 point Likert scale, with 1 corresponding to the maximum frequency ("all of the time") and 7 to the minimum ("none of the time"). Domain scores are the means of the items contained. A summary score is calculated by the mean of all domain scores (CLDQ-HCV Global). Higher scores indicate better health-related quality of life.

  Baseline, Week 72

Secondary Outcomes (5)

• Change From Baseline to Week 72 (WK72) in SF-36 Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis)

  Baseline, Week 72

• Change From Baseline to Week 72 (WK72) in CLDQ-HCV Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis)

  Baseline, Week 72

• Minimal Clinically Important Difference (MCID) in SF-36 Scores

  From Baseline Visit to Final Visit (up to 72 weeks)

• MCID in CLDQ-HCV Scores

  From Baseline Visit to Final Visit (up to 72 weeks)

• Percentage of Participants Who Were Compliant With Treatment According To Medication Count (Subset Analysis)

  From Baseline Visit to Final Visit (up to 72 weeks)

Study Arms (1)

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.

Biological: Peginterferon alfa-2b (PEG); Drug: Ribavirin (RBV)

Interventions

Peginterferon alfa-2b (PEG) BIOLOGICAL

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

Also known as: PegIntron, SCH 054031

PEG + RBV (Standard Clinical Practice)

Ribavirin (RBV) DRUG

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

Also known as: Rebetol, SCH 18908

PEG + RBV (Standard Clinical Practice)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with Chronic Hepatitis C, Genotype 1, no other co-infection and compensated liver disease who receive PEG and RBV in combination therapy according to standard clinical practice.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2b; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2009
• First Posted: March 17, 2009
• Study Start: April 1, 2009
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: April 7, 2017
• Results First Posted: June 12, 2014

Record last verified: 2017-03