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Trial registered on ANZCTR


Registration number
ACTRN12610000830099
Ethics application status
Not yet submitted
Date submitted
27/09/2010
Date registered
5/10/2010
Date last updated
5/10/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
The aim of the study is to determine if the development of thyroid disease during treatment with Ribavirin and Interferon-alpha for chronic hepatitis C delivers a better chance of achieving a viral cure.
Scientific title
The development of thyroid disease is a favorable factor in achieving sustained virologic response in patients with chronic hepatitis C undergoing combination therapy: A nested case control study.
Secondary ID [1] 252770 0
Nil
Universal Trial Number (UTN)
NIL
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thyroid Disease 258271 0
Chronic hepatitis C 258286 0
Thyroid disease 258323 0
Condition category
Condition code
Metabolic and Endocrine 258462 258462 0 0
Thyroid disease
Inflammatory and Immune System 258481 258481 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Exposure to thyroid disease confers a favorable sustained virologic response in chronic hepatitis C undergoing combination therapy. Patients who developed thyroid disease during treatment with Interferon and Ribavirin will be observed for 6 months after end of treatment to ascertain viral outcome.
Intervention code [1] 257303 0
Not applicable
Comparator / control treatment
This is a nested case control study. The historical data was collected over a 5 year period from 2005-2008, including sustained virologic response in chronic hepatitis C patients without thyroid disease.
Control group
Historical

Outcomes
Primary outcome [1] 259298 0
Sustained Virologic Response in patients undergoing combination Interferon-alpha and Ribavirin treatments. Sustained virologic response is defined as undetectable Hepatitis C virus-ribonucleic acid (HCV-RNA) by polymerase chain reaction (PCR) tests at 6 months after completion of combination treatment.
Timepoint [1] 259298 0
Six months after the completion of above treatment.
Secondary outcome [1] 265726 0
N/A
Timepoint [1] 265726 0
N/A

Eligibility
Key inclusion criteria
Patients with thyroid disease during treatment for chronic hepatitis C vs. no thyroid disease.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cirrhosis, pre-existing thyroid diseases, hepatitides other than hepatitis C.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Case control
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257723 0
Self funded/Unfunded
Name [1] 257723 0
HUY A. TRAN
Address [1] 257723 0
Hunter Area Pathology Service
Locked Bag 1, Hunter Region Mail Centre
Newcastle
New South Wales 2310
Country [1] 257723 0
Australia
Primary sponsor type
Hospital
Name
Hunter Area Pathology Service
Address
Locked Bag 1, Hunter Region Mail Centre
Newcastle
New South Wales 2310
Country
Australia
Secondary sponsor category [1] 256952 0
None
Name [1] 256952 0
Address [1] 256952 0
Country [1] 256952 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259817 0
Newcastle University Ethics Committee
Ethics committee address [1] 259817 0
Callaghan Drive
Newcastle 2310
New South Wales
Ethics committee country [1] 259817 0
Australia
Date submitted for ethics approval [1] 259817 0
01/11/2010
Approval date [1] 259817 0
Ethics approval number [1] 259817 0

Summary
Brief summary
Hepatitis C is one of the major global causes of chronic hepatic infections, particularly in third world countries, and is associated with a significant rate of cirrhosis and hepatoma. In Australia and the United States of America, the burden of disease is significant. Unfortunately, the incidence and associated sequelae have been predicted to increase in the coming decades. Consequently, a large and growing number of patients will undergo treatment for hepatitis C. Of those receiving combination treatment with interferon (IFN)-a and ribavirin (RBV), approximately 5-10% will develop thyroid-related complications. Whilst there are a number of favourable factors in the prediction of favourable hepatic outcome such as genotype, ethnicity, and early viral load reduction, there are few published reports that assess the development of thyroid disease (TD) in relation to sustained virological response (SVR). Our previous meta-analysis did not find any difference, although this may be due to inherent differences in the published reports. The aim of this report is to investigate the hypothesis that the development of thyroid disease in patients treated for HCV is associated with a significantly increased likelihood of attaining SVR.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 31706 0
Address 31706 0
Country 31706 0
Phone 31706 0
Fax 31706 0
Email 31706 0
Contact person for public queries
Name 14953 0
HUY A. TRAN
Address 14953 0
Hunter Area Pathology Service
Executive Office, Level 2
HAPS Building
Outlook Drive
New Lambton Heights 2305
New South Wales, Australia
Country 14953 0
Australia
Phone 14953 0
+61 2 4921 4005
Fax 14953 0
+61 2 4921 4440
Email 14953 0
huy.tran@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 5881 0
HUY A. TRAN
Address 5881 0
Hunter Area Pathology Service
Executive Office, Level 2
HAPS Building
Outlook Drive
New Lambton Heights 2305
New South Wales, Australia
Country 5881 0
Australia
Phone 5881 0
+61 2 4921 4005
Fax 5881 0
+61 2 4921 4440
Email 5881 0
huy.tran@hnehealth.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary