In Hepatitis C Patients Treated With Interferon and Ribavirin, Does Hepcidin Contribute to Treatment Induced Anaemia

Study Overview
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Brief Summary
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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 containing regimes. 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.

Official Title
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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

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: Pegylated interferon alpha
* Drug: Ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any patient with hepatitis C eligible for treatment with pegylated interferon alpha containing regimes. Exclusion Criteria: less than 18 years of age

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Interferon and ribavirin<br>Treatment with standard of care pegylated interferon alpha and ribavirin. | Drug: Pegylated interferon alpha<br>* Subcutaneous weekly pegylated interferon alpha and daily oral ribavirin treatment as per standard treatment. The dosages for interferon and ribavirin are as per therapeutic guidelines and are based on weight, genotype and previous treatments.<br>* Other names: pegatron;Drug: Ribavirin<br>* Subcutaneous weekly pegylated interferon alpha and daily oral ribavirin treatment as per standard treatment. The dosages for interferon and ribavirin are as per therapeutic guidelines and are based on weight, genotype and previous treatments.<br>* Other names: Virazole;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepcidin levels | To measure changes in serum hepcidin levels during pegylated interferon alpha and ribavirin therapy in subjects with chronic hepatitis C infection. | Measured at -2 weeks, start of treatment and week 3,4,8, 12 and 24. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| iron metabolism markers | 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. | Measured at -2 weeks, start of treatment and week 3,4,8, 12 and 24. | 
| heamolysis markers | 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. | Measured at -2 weeks, start of treatment and week 3,4,8, 12 and 24. | 
| inosine triphosphatase genetic variants | 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. | Baseline | 
| erythropoiesis markers | 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. | Measured at -2 weeks, start of treatment and week 3,4,8, 12 and 24. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C, Interferon, Ribavirin, Hepcidin, Iron metabolism