Clinical trial NCT01726400: In Hepatitis C Patients Treated With Interferon and Ribavirin, Does Hepcidin Contribute to Treatment Induced Anaemia
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Keywords: Hepatitis C
Interferon
Ribavirin
Hepcidin
Iron metabolism
Lead sponsor: Fremantle Hospital and Health Service
Sponsor class: OTHER
First posted: 2012-11-14
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hepatitis C patients undergoing standard of care treatment with interferon alpha.

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.


Eligibility 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

Primary outcomes:
measure: Hepcidin levels
timeFrame: Measured at -2 weeks, start of treatment and week 3,4,8, 12 and 24.
Secondary outcomes:
measure: iron metabolism markers
timeFrame: Measured at -2 weeks, start of treatment and week 3,4,8, 12 and 24.
measure: heamolysis markers
timeFrame: Measured at -2 weeks, start of treatment and week 3,4,8, 12 and 24.
measure: inosine triphosphatase genetic variants
timeFrame: Baseline
measure: erythropoiesis markers
timeFrame: Measured at -2 weeks, start of treatment and week 3,4,8, 12 and 24.
Other outcomes:
Locations:
city: Fremantle
country: Australia
facility: Fremantle Hospital
state: Western Australia
Study officials:
affiliation: South Metropolitan Health Service, Perth Western Australia
name: Marius M Van Rijnsoever, MBBS
role: PRINCIPAL_INVESTIGATOR
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