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

Information source: Fremantle Hospital and Health Service
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C

Intervention: Pegylated interferon alpha (Drug); Ribavirin (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Fremantle Hospital and Health Service

Official(s) and/or principal investigator(s):
Marius M Van Rijnsoever, MBBS, Principal Investigator, Affiliation: South Metropolitan Health Service, Perth Western Australia

Overall contact:
Marius M Van Rijnsoever, MBBS, Phone: +61-8-9431-3333, Email: Marius.vanrijnsoever@health.wa.gov.au

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.

Clinical Details

Official title: 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

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: Hepcidin levels

Secondary outcome:

iron metabolism markers

heamolysis markers

inosine triphosphatase genetic variants

erythropoiesis markers

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Any patient with hepatitis C eligible for treatment with pegylated interferon alpha

containing regimes. Exclusion Criteria:

- less than 18 years of age

Locations and Contacts

Marius M Van Rijnsoever, MBBS, Phone: +61-8-9431-3333, Email: Marius.vanrijnsoever@health.wa.gov.au

Fremantle Hospital, Fremantle, Western Australia 6160, Australia; Recruiting
Marius M Van Rijnsoever, MBBS, Phone: +61-8-9431-3333, Email: marius.vanrijnsoever@health.wa.gov.au
Marius M Van Rijnsoever, MBBS, Principal Investigator
Additional Information

australian new zealand clinical trials register

Related publications:

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.

Kwo PY, Lawitz EJ, McCone J, Schiff ER, Vierling JM, Pound D, Davis MN, Galati JS, Gordon SC, Ravendhran N, Rossaro L, Anderson FH, Jacobson IM, Rubin R, Koury K, Pedicone LD, Brass CA, Chaudhri E, Albrecht JK; SPRINT-1 investigators. Efficacy of boceprevir, an NS3 protease inhibitor, in combination with peginterferon alfa-2b and ribavirin in treatment-naive patients with genotype 1 hepatitis C infection (SPRINT-1): an open-label, randomised, multicentre phase 2 trial. Lancet. 2010 Aug 28;376(9742):705-16. doi: 10.1016/S0140-6736(10)60934-8. Epub 2010 Aug 6. Erratum in: Lancet. 2010 Oct 9;376(9748):1224. SPRINT-1 investigators [added]; multiple investigator names added.

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Thompson AJ, Clark PJ, Singh A, Ge D, Fellay J, Zhu M, Zhu Q, Urban TJ, Patel K, Tillmann HL, Naggie S, Afdhal NH, Jacobson IM, Esteban R, Poordad F, Lawitz EJ, McCone J, Shiffman ML, Galler GW, King JW, Kwo PY, Shianna KV, Noviello S, Pedicone LD, Brass CA, Albrecht JK, Sulkowski MS, Goldstein DB, McHutchison JG, Muir AJ. Genome-wide association study of interferon-related cytopenia in chronic hepatitis C patients. J Hepatol. 2012 Feb;56(2):313-9. doi: 10.1016/j.jhep.2011.04.021. Epub 2011 May 20.

Starting date: December 2012
Last updated: March 7, 2013

Page last updated: August 23, 2015

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