Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001188921
Ethics application status
Approved
Date submitted
11/11/2011
Date registered
16/11/2011
Date last updated
11/03/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Is hepcidin a possible contributor to impaired iron mobilization and anaemia in hepatitis C patients treated with pegylated interferon alpha and ribavirin therapy? A pilot study
Scientific title
In hepatitis C patients treated with interferon and ribavirin, does hepcidin contribute to treatment induced anaemia?
Secondary ID [1] 273364 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 279141 0
Anaemia 279153 0
Condition category
Condition code
Infection 279330 279330 0 0
Other infectious diseases
Blood 279342 279342 0 0
Anaemia
Oral and Gastrointestinal 279343 279343 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Subcutaneous weekly pegylated interferon alpha containing regimens as per standard treatment. The dosages for interferon and ribavirin are as per therapeutic guidelines and are based on weight, genotype and previous treatments. Patients will be observed during their Hep C treatment for up to 24 weeks.
Intervention code [1] 283706 0
Not applicable
Comparator / control treatment
Single group trial
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279936 0
To measure changes in serum hepcidin levels during pegylated interferon alpha and ribavirin therapy in subjects with chronic hepatitis C infection.
Timepoint [1] 279936 0
Measured at -2 weeks, start of treatment and week 3,4,8, 12 and 24.
Secondary outcome [1] 294806 0
To measure changes in iron metabolism (reticulocyte haemoglobin, serum iron, transferrin saturation and ferritin levels) during pegylated interferon alpha and ribavirin therapy in subjects with chronic hepatitis C infection.
Timepoint [1] 294806 0
Measured at -2 weeks, start of treatment and week 3,4,8, 12 and 24.
Secondary outcome [2] 294817 0
To detect ribavirin induced heamolysis by measuring serum haptoglobin and free haemoglobin during pegylated interferon alpha and ribavirin therapy in subjects with chronic hepatitis C infection.
Timepoint [2] 294817 0
Measured at -2 weeks, start of treatment and week 3,4,8, 12 and 24.
Secondary outcome [3] 294818 0
To measure the effect of inosine triphosphatase genetic variants on anemia during pegylated interferon alpha and ribavirin therapy in subjects with chronic hepatitis C infection.
Timepoint [3] 294818 0
at the start of treatment
Secondary outcome [4] 294819 0
To measure the level of erythropoiesis (IL1, IL6, erythropoietin and reticulocyte) during pegylated interferon alpha and ribavirin therapy in subjects with chronic hepatitis C infection.
Timepoint [4] 294819 0
Measured at -2 weeks, start of treatment and week 3,4,8, 12 and 24.

Eligibility
Key inclusion criteria
We will prospectively study 30 consecutive patients with Hepatitis C infection that are being treated with interferon alpha and ribavirin at Fremantle hospital.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
participation in other clinical trials.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2012
Actual
1/11/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 731 0
Fremantle Hospital and Health Service - Fremantle

Funding & Sponsors
Funding source category [1] 284184 0
Commercial sector/Industry
Name [1] 284184 0
MSD Australia
Country [1] 284184 0
Australia
Primary sponsor type
Individual
Name
Prof John Olynyk
Address
Fremantle Hospital
Alma St
Fremantle WA 6120
Australia
Country
Australia
Secondary sponsor category [1] 269140 0
Individual
Name [1] 269140 0
Dr Marius van Rijnsoever
Address [1] 269140 0
Fremantle Hospital
Alma St
Fremantle WA 6120
Australia
Country [1] 269140 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286151 0
South Metropolitan Area Health Service Human Research Ethics Committee
Ethics committee address [1] 286151 0
Fremantle Hospital
Alma St
Fremantle WA 6120
Ethics committee country [1] 286151 0
Australia
Date submitted for ethics approval [1] 286151 0
25/05/2011
Approval date [1] 286151 0
16/08/2011
Ethics approval number [1] 286151 0
1/11/0225

Summary
Brief summary
The standard treatment of chronic hepatitis C infection is pegylated interferon alpha combined with ribavirin. Anaemia is a common complication occurring in up to 30% of subjects. Unfortunately, side effects of interferon and ribavirin therapy can require dose reductions, reducing the likelihood of sustained viral response. Recent data shows that interferon alpha may increase hepcidin (a key iron regulator) production, resulting in impaired iron availability for production of red blood cells. In this study, we will evaluate hepcidin levels in 30 patients with Hepatitis C who are treated with interferon alpha containing regimens as per standard of care treatment. If hepcidin plays a role in interferon-induced anaemia, cheap and readily available oral hepcidin inhibitors could be trialled to potentially reduce the impact of interferon alpha induced anaemia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33377 0
Dr Marius van Rijnsoever
Address 33377 0
Fremantle Hospital Alma St Fremantle WA 6120
Country 33377 0
Australia
Phone 33377 0
+61 8 94313333
Fax 33377 0
Email 33377 0
Marius.VanRijnsoever@health.wa.gov.au
Contact person for public queries
Name 16624 0
Dr Marius van Rijnsoever
Address 16624 0
Fremantle Hospital
Alma St
Fremantle WA 6120
Country 16624 0
Australia
Phone 16624 0
+61 8 94313333
Fax 16624 0
Email 16624 0
Marius.VanRijnsoever@health.wa.gov.au
Contact person for scientific queries
Name 7552 0
Dr Marius van Rijnsoever
Address 7552 0
Fremantle Hospital
Alma St
Fremantle WA 6120
Country 7552 0
Australia
Phone 7552 0
+61 8 94313333
Fax 7552 0
Email 7552 0
Marius.VanRijnsoever@health.wa.gov.au

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
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Documents added automatically
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