Chronic Hepatitis CNCT01178749
Exploration of Chronic Hepatitis C Infection Receiving 24-week Interferon-α With Ribavirin Treatments
An observational study of Chronic Hepatitis C, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C
- How many people
- 390 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2007to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic Hepatitis C inpatients
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Shiow-Ching Shun, Ph.aD, 886-2-23123456 ext. 88439, scshun@ntu.edu.tw
About this study
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
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.
Read the 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
- Keywords
- Hepatitis C, Interferon, Symptom Distress, Quality of Life
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Hepatitis C Infection | patients Receiving 24-week Interferon-α with Ribavirin Treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptom distress Scale
Measured: 6 months
Fatigue symptom inventory
Measured: 6 months
The SF-12 health survey
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2010 (estimated)
- Study startSep 2007
- Primary completionJul 2010 (estimated)
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Investigators
- Shiow-Ching Last, PhD, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01178749
- Sponsor's protocol ID
- 200708003R
- Status last verified
- Aug 2010
- First submitted
- 11 Apr 2010
- Last updated
- 10 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01178749
- Acronym / sponsor ID
- 200708003R
- Conditions
- Chronic Hepatitis C
- Keywords
- Hepatitis C, Interferon, Symptom Distress, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Sep 2007
- Primary completion
- Jul 2010 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 10 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Hepatitis C Infection | – | –patients Receiving 24-week Interferon-α with Ribavirin Treatments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic Hepatitis C inpatients
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
symptom distress Scale
Time frame: 6 months
Fatigue symptom inventory
Time frame: 6 months
The SF-12 health survey
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2010.
Related trials for Chronic Hepatitis C
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"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiow-Ching Last, PhD principal investigator
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis C, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shiow-Ching Shun, Ph.D (886-2-23123456 ext. 88439, scshun@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
symptom distress Scale (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2010.