RecruitingACTRN12611001188921

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

In hepatitis C patients treated with interferon and ribavirin, does hepcidin contribute to treatment induced anaemia?

Sponsor

Prof John Olynyk

Enrollment

30 participants

Start Date

Nov 1, 2012

Study Type

Observational

Conditions

Hepatitis C Anaemia

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.

Eligibility

Sex: Both males and females

Plain Language Summary

Simplified for easier understanding

This study looks at a blood protein called hepcidin in people with Hepatitis C who are being treated with interferon and ribavirin. These treatments often cause anaemia (low red blood cell counts) as a side effect. Researchers think hepcidin might be partly responsible because it blocks iron from being used to make new red blood cells. By measuring hepcidin levels in 30 patients during treatment, researchers hope to find out if hepcidin is a useful target to help prevent anaemia during Hepatitis C therapy. You may be eligible if: - You have a confirmed diagnosis of chronic Hepatitis C infection - You are currently being treated with interferon alpha and ribavirin at Fremantle Hospital You may NOT be eligible if: - You are already participating in another clinical trial Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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.