Exploration of Chronic Hepatitis C Infection Receiving 24-week Interferon-α With Ribavirin Treatments

NCT ID: NCT01178749

Last Updated: 2010-08-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 390 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2011-07-31

Brief Summary

The aims of this three-year study are to explore symptom experience and its related factors for the patients with chronic hepatitis C Infection receiving interferon-α with ribavirin for 24 weeks and further to predict the relative risk of failure or occurence of severe side effects which interrupt the treatment.

Detailed Description

The antiviral treatment, interferon-α with ribavirin, has been used in treating chronic hepatitis C patients to prevent the development of liver cirrhosis and hepatocellular carcinoma. However, the duration of this treatment needs at least 6 months and severe side effects such as anemia, fatigue, depression with suicidal thoughts can occur at any time throughout the treatment. There has been no study related to the issue of the risk to the population of developing these severe side effects and failing the treatment. Therefore, the aims of this three-year study are to explore symptom experience and its related factors for the patients with chronic hepatitis C Infection receiving interferon-α with ribavirin for 24 weeks and further to develop a prediction model for individuals to predict the relative risk of failure or occurence of severe side effects which interrupt the treatment. Patients will be recruited from outpatients in two hospitals in Northern and Middle Taiwan. A longitudinal study is designed with a one-year follow-up at pre-treatment, and at the 1, 2, 4, 6, 8, 12,16,20, 24 weeks during treatment, and at the 4, 12, 24 weeks of post-treatment. The basic information including the laboratory data, the Symptom Distress Scale, the Fatigue Symptom Inventory, the Hospital Anxiety and Depression Scale, MOS, and the Short-Form 12 Health-Related Quality of Life questionnaires will be used to assess patients' demographic characteristics, symptom experience, fatigue, depression, anxiety, sleep disturbance, and quality of life during the treatment. Three hundred patients will be interviewed within three years. The data will be analyzed using descriptive, independent t-test, Pearson's correlation, Analysis of Variances, generalized estimating equations, logistic regression, and classification tree. We expect this study to explore the characteristics of the population with high risks of treatment failure to severe side effects during treatment in Taiwan. In addition, the results can provide the information for clinicians and researchers to tailor interventions to individual needs.

Conditions

Chronic Hepatitis C

Study Design

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

Study Groups

Chronic Hepatitis C Infection

patients Receiving 24-week Interferon-α with Ribavirin Treatments

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• patients with Chronic Hepatitis C Infection Receiving 24-week Interferon-α with Ribavirin Treatments
• Those Who willing to participate in the research
• Aged above 18

Exclusion Criteria

• None

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

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

National Taiwan University

Principal Investigators

Shiow-Ching Last, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Shiow-Ching Shun, Ph.D

Role: CONTACT

scshun@ntu.edu.tw

886-2-23123456 ext. 88439

Facility Contacts

Shiow-Ching Shun, Ph.aD

Role: primary

scshun@ntu.edu.tw

886-2-23123456 ext. 88439

Other Identifiers

200708003R

Identifier Type: -

Identifier Source: org_study_id