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

Completed

• Conditions: Hepatitis C
• Interventions: Drug: Pegylated interferon alpha; Drug: Ribavirin

• Registration Number: NCT01726400
• Lead Sponsor: Fremantle Hospital and Health Service

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-09
• Study First Submitted QC: 2012-11-13
• Study First Posted: 2012-11-14
• Study Start: 2012-12
• Primary Completion: 2014-01
• Study Completion: 2014-07
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-09
• Last Update Posted: 2015-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Any patient with hepatitis C eligible for treatment with pegylated interferon alpha containing regimes.

Exclusion Criteria

• less than 18 years of age

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Interferon and ribavirin	Pegylated interferon alpha	Treatment with standard of care pegylated interferon alpha and ribavirin.
Interferon and ribavirin	Ribavirin	Treatment with standard of care pegylated interferon alpha and ribavirin.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fremantle Hospital; 🇦🇺 Fremantle, Western Australia, Australia