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

This study is currently recruiting participants.
Verified March 2013 by Fremantle Hospital and Health Service
Sponsor:
Information provided by (Responsible Party):
Dr Marius van Rijnsoever, Fremantle Hospital and Health Service
ClinicalTrials.gov Identifier:
NCT01726400
First received: November 9, 2012
Last updated: March 7, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Hepatitis C
 Drug: Pegylated interferon alpha
Drug: Ribavirin

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fremantle Hospital and Health Service:

Primary Outcome Measures:
  • Hepcidin levels [ Time Frame: Measured at -2 weeks, start of treatment and week 3,4,8, 12 and 24. ] [ Designated as safety issue: No ]
    To measure changes in serum hepcidin levels during pegylated interferon alpha and ribavirin therapy in subjects with chronic hepatitis C infection.


Secondary Outcome Measures:
  • iron metabolism markers [ Time Frame: Measured at -2 weeks, start of treatment and week 3,4,8, 12 and 24. ] [ Designated as safety issue: No ]
    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.

  • heamolysis markers [ Time Frame: Measured at -2 weeks, start of treatment and week 3,4,8, 12 and 24. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • erythropoiesis markers [ Time Frame: Measured at -2 weeks, start of treatment and week 3,4,8, 12 and 24. ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

Whole blood is collect for genomic DNA extraction. Serum samples will be stored for hepcidin analysis.


Estimated Enrollment: 30
Study Start Date: December 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
  • Ribasphere
  • Vilona
  • Virazole

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726400

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

Locations
Australia, Western Australia
Fremantle Hospital Recruiting
Fremantle, Western Australia, Australia, 6160
Contact: Marius M Van Rijnsoever, MBBS     +61-8-9431-3333     marius.vanrijnsoever@health.wa.gov.au    
Principal Investigator: Marius M Van Rijnsoever, MBBS            
Sponsors and Collaborators
Fremantle Hospital and Health Service
Investigators
Principal Investigator: Marius M Van Rijnsoever, MBBS South Metropolitan Health Service, Perth Western Australia
  More Information

Additional Information:
australian new zealand clinical trials register  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Dr Marius van Rijnsoever, Medical Registrar, Fremantle Hospital and Health Service
ClinicalTrials.gov Identifier: NCT01726400     History of Changes
Other Study ID Numbers: HEPCIDIN-11/225
Study First Received: November 9, 2012
Last Updated: March 7, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Fremantle Hospital and Health Service:
Hepatitis C
Interferon
Ribavirin
Hepcidin
Iron metabolism

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon-alpha
Interferon Alfa-2a
Interferons
Ribavirin
 Hepcidin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 22, 2013