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

Hepatitis C research study

What is the primary objective of this 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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Hepatitis C

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Pegylated interferon alphaSubcutaneous 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.

Drug:RibavirinSubcutaneous 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Interferon and ribavirinTreatment with standard of care pegylated interferon alpha and ribavirin.

Study Status

Completed

Start Date: December 2012

Completed Date: July 2014

Phase:

Type: Observational

Design:

Primary Outcome: Hepcidin levels

Secondary Outcome: iron metabolism markers

Study sponsors, principal investigator, and references

Principal Investigator: Marius M Van Rijnsoever, MBBS

Lead Sponsor: Fremantle Hospital and Health Service

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01726400

Poordad F. Big changes are coming in hepatitis C. Curr Gastroenterol Rep. 2011 Feb;13(1):72-7. doi: 10.1007/s11894-010-0153-9.

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