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

Hepatitis C, Chronic Clinical Trial

Official title:

A Quality of Life Study of Pegasys (Peginterferon-Alfa2a) in Combination With Copegus (Ribavirin) in Patients With Chronic Hepatitis C and Persistently Normal ALT Levels

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02726022
• Other study ID #: ML20151
• Status: Completed
• Phase: N/A
• First received: March 29, 2016
• Last updated: April 2, 2016
• Start date: February 2007
• Est. completion date: July 2011

Study information

• Verified date: April 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Drugs Organisation
• Study type: Observational

Clinical Trial Summary

Participants with 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 Short Form 36 (SF-36) questionnaire, modified for the Greek population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Pregnant or lactating women

• Coinfection 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Drug:
• Peginterferon alfa-2a
Peginterferon alfa-2a will be administered subcutaneously as 180 mcg once weekly, according to standard clinical practice.
• Ribavirin
Ribavirin will be given orally as 800 to 1000 mg once daily, according to standard clinical practice.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SF-36 Score		At 24 weeks after end of treatment (up to 72 weeks overall)	No
Secondary	Percentage of Participants with Adverse Events		Up to 72 weeks (visit frequency according to standard clinical practice)	No