Trial Review

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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
Sex
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
1/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
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
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
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
Trial website
Trial related presentations / publications
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
[email protected]
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
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThyroid disease is a favorable prognostic factor in achieving sustained virologic response in chronic hepatitis C undergoing combination therapy: A nested case control study.2011https://dx.doi.org/10.1186/1472-6823-11-10
N.B. These documents automatically identified may not have been verified by the study sponsor.