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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01178749
First received: April 11, 2010
Last updated: August 9, 2010
Last verified: August 2010
  Purpose

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.


Condition
Chronic Hepatitis C

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Exploration of Symptom Experience and Related Factors for Patients With Chronic Hepatitis C Infection Receiving 24-week Interferon-α With Ribavirin Treatments: Development of a Prediction Model

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • symptom distress Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Fatigue symptom inventory [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The SF-12 health survey [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 390
Study Start Date: September 2007
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Chronic Hepatitis C Infection
patients Receiving 24-week Interferon-α with Ribavirin Treatments

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Chronic Hepatitis C inpatients

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01178749

Contacts
Contact: Shiow-Ching Shun, Ph.D 886-2-23123456 ext 88439 scshun@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Shiow-Ching Shun, Ph.aD    886-2-23123456 ext 88439    scshun@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Investigators
Principal Investigator: Shiow-Ching Last, PhD National Taiwan University
  More Information

No publications provided

Responsible Party: Shiow-Ching Shun / Assistant Professor, National Taiwan University
ClinicalTrials.gov Identifier: NCT01178749     History of Changes
Other Study ID Numbers: 200708003R
Study First Received: April 11, 2010
Last Updated: August 9, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Hepatitis C
Interferon
Symptom Distress
Quality of Life

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Ribavirin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014