A Quality of Life Study of Peginterferon-Alfa-2a Plus Ribavirin in Participants With Chronic Hepatitis C and Persistently Normal Alanine Transaminase (ALT) Levels

NCT02726022 | Completed Results

• 1 other identifier: ML20151
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 10

Brief Summary

Participants with Chronic Hepatitis C (CHC) and normal ALT, who have been under treatment with peginterferon alfa-2a and ribavirin for at least 4 weeks, will be enrolled into this non-interventional, open-label study. The primary aim is to evaluate quality of life according to the 36-Item Short-Form Health Survey (SF-36) questionnaire, modified for the Greek population.

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (6)

• Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Domain at End of Treatment (EOT)

  SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for general health domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). Data was reported by status of gender (male and female) and drug addiction (yes and no).

  Baseline, EOT (up to 48 weeks)

• Change From Baseline in SF-36 General Health Domain at 24 Weeks After EOT

  SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for general health domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). Data was reported by status of gender (male and female) and drug addiction (yes and no).

  Baseline, 24 weeks after EOT (up to 72 weeks)

• Change From Baseline in SF-36 Physical Component Summary (PCS) at EOT

  SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning).

  Baseline, EOT (up to 48 weeks)

• Change From Baseline in SF-36 PCS at 24 Weeks After EOT

  SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning).

  Baseline, 24 weeks after EOT (up to 72 weeks)

• Change From Baseline in SF-36 Mental Component Summary (MCS) at EOT

  SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning).

  Baseline, EOT (up to 48 weeks)

• Change From Baseline in SF-36 MCS at 24 Weeks After EOT

  SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning).

  Baseline, 24 weeks after EOT (up to 72 weeks)

Study Arms (1)

Chronic Hepatitis C Participants

Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, will be observed up to 24 weeks after end of treatment (EOT) (up to 72 weeks). Peg-interferon alfa-2a and ribavirin will be administered as per treating physician discretion and according to summary of product characteristics.

Drug: Peginterferon alfa-2a; Drug: Ribavirin

Interventions

Peginterferon alfa-2a DRUG

As per treating physician discretion and according to summary of product characteristics.

Also known as: Pegasys

Chronic Hepatitis C Participants

Ribavirin DRUG

As per treating physician discretion and according to summary of product characteristics.

Also known as: Copegus

Chronic Hepatitis C Participants

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 CHC and persistently normal ALT levels who have been receiving peginterferon alfa-2a and ribavirin for at least 4 weeks.

You may qualify if:

• Serological confirmation of chronic infection by anti-hepatitis C virus (HCV) assay
• HCV ribonucleic acid (RNA) positive
• CHC with normal transaminases
• Compensated liver disease
• Non-pregnant and willing to use two contraceptive methods (if fertile)
• At least 4 weeks of prior treatment with peginterferon alfa-2a and ribavirin

You may not qualify if:

• Pregnant or lactating women
• Co-infection with hepatitis A or B, or human immunodeficiency virus (HIV)
• History of seizures or depression
• History of autoimmune disease, severe heart or lung disease, or renal failure with reduced creatinine clearance
• Uncontrolled thyroid disease
• Severe retinopathy
• Leukopenia or thrombocytopenia
• Bleeding esophageal varices or other evidence of hepatic decompensation

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (10)

Unknown Facility

Aigaleo - Attiki, 12241, Greece

Location

Unknown Facility

Athens, 115 27, Greece

Location

Unknown Facility

Athens, 11522, Greece

Location

Unknown Facility

Athens, 11526, Greece

Location

Unknown Facility

Athens, 11527, Greece

Location

Unknown Facility

Athens, 11528, Greece

Location

Unknown Facility

Heraklion, 71100, Greece

Location

Unknown Facility

Piraeus, 18454, Greece

Location

Unknown Facility

Piraeus, 18536, Greece

Location

Unknown Facility

Thessaloniki, 546 42, Greece

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2a; 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: Medical Communications
• Organization: Hoffman-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

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 29, 2016
• First Posted: April 1, 2016
• Study Start: February 1, 2007
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: August 15, 2016
• Results First Posted: August 15, 2016

Record last verified: 2016-04

Locations

GR (10)