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

November 9, 2015 updated by: Dr Marius van Rijnsoever, Fremantle Hospital and Health Service

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • Fremantle Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hepatitis C patients undergoing standard of care treatment with interferon alpha.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Interferon and ribavirin
Treatment with standard of care pegylated interferon alpha and ribavirin.
Drug: Pegylated interferon alpha
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.
Other Names:
  • pegasys
  • pegatron
Drug: Ribavirin
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.
Other Names:
  • Copegus
  • Rebetol
  • Virazole
  • Ribasphere
  • Vilona

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fremantle Hospital and Health Service

Investigators

  • Principal Investigator: Marius M Van Rijnsoever, MBBS, South Metropolitan Health Service, Perth Western Australia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

November 9, 2012

First Submitted That Met QC Criteria

November 13, 2012

First Posted (Estimate)

November 14, 2012

Study Record Updates

Last Update Posted (Estimate)

November 10, 2015

Last Update Submitted That Met QC Criteria

November 9, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEPCIDIN-11/225

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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