NCT01178749

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
390

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 10, 2010

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

August 10, 2010

Status Verified

August 1, 2010

Enrollment Period

2.8 years

First QC Date

April 11, 2010

Last Update Submit

August 9, 2010

Conditions

Chronic Hepatitis C

Keywords

Hepatitis CInterferonSymptom DistressQuality of Life

Outcome Measures

Primary Outcomes (3)

  • symptom distress Scale

    6 months

  • Fatigue symptom inventory

    6 months

  • The SF-12 health survey

    6 months

Study Arms (1)

Chronic Hepatitis C Infection

patients Receiving 24-week Interferon-α with Ribavirin Treatments

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chronic Hepatitis C inpatients

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Hepatitis C, ChronicHepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Shiow-Ching Last, PhD

    National Taiwan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shiow-Ching Shun, Ph.D

CONTACT

886-2-23123456scshun@ntu.edu.tw

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 11, 2010

First Posted

August 10, 2010

Study Start

September 1, 2007

Primary Completion

July 1, 2010

Study Completion

July 1, 2011

Last Updated

August 10, 2010

Record last verified: 2010-08

Locations

TW(1)