Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interferon and ribavirin | Treatment with standard of care pegylated interferon alpha and ribavirin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegylated interferon alpha | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hepcidin levels | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| iron metabolism markers | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Hepatitis C patients undergoing standard of care treatment with interferon alpha.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marius M Van Rijnsoever, MBBS | South Metropolitan Health Service, Perth Western Australia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fremantle Hospital | Fremantle | Western Australia | 6160 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21063814 | Background | 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. | |
| 20692693 | Background | 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. |
| Label | URL |
|---|---|
| australian new zealand clinical trials register | View source |
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 22, 2015 | |
| Reset | Dec 24, 2015 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 22, 2015 | Dec 24, 2015 |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
Not provided
Not provided
| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
Not provided
Not provided
Not provided
Whole blood is collect for genomic DNA extraction. Serum samples will be stored for hepcidin analysis.
|
| Ribavirin | Drug | 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. |
|
|
| heamolysis markers |
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 | 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 | 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. |
| 17168855 | Background | Russmann S, Grattagliano I, Portincasa P, Palmieri VO, Palasciano G. Ribavirin-induced anemia: mechanisms, risk factors and related targets for future research. Curr Med Chem. 2006;13(27):3351-7. doi: 10.2174/092986706778773059. |
| 17943492 | Background | Chua AC, Graham RM, Trinder D, Olynyk JK. The regulation of cellular iron metabolism. Crit Rev Clin Lab Sci. 2007;44(5-6):413-59. doi: 10.1080/10408360701428257. |
| 18752323 | Background | Olynyk JK, Trinder D, Ramm GA, Britton RS, Bacon BR. Hereditary hemochromatosis in the post-HFE era. Hepatology. 2008 Sep;48(3):991-1001. doi: 10.1002/hep.22507. |
| 20801192 | Background | Zhang X, Rovin BH. Hepcidin expression by human monocytes in response to adhesion and pro-inflammatory cytokines. Biochim Biophys Acta. 2010 Dec;1800(12):1262-7. doi: 10.1016/j.bbagen.2010.08.005. Epub 2010 Aug 27. |
| 18322945 | Background | Ward DG, Roberts K, Brookes MJ, Joy H, Martin A, Ismail T, Spychal R, Iqbal T, Tselepis C. Increased hepcidin expression in colorectal carcinogenesis. World J Gastroenterol. 2008 Mar 7;14(9):1339-45. doi: 10.3748/wjg.14.1339. |
| 20470305 | Background | Ferrari P, Mallon D, Trinder D, Olynyk JK. Pentoxifylline improves haemoglobin and interleukin-6 levels in chronic kidney disease. Nephrology (Carlton). 2010 Apr;15(3):344-9. doi: 10.1111/j.1440-1797.2009.01203.x. |
| 16810960 | Background | Owen JA, de Gruchy GC, Smith H. SERUM HAPTOGLOBINS IN HAEMOLYTIC STATES. J Clin Pathol. 1960 Nov;13(6):478-82. doi: 10.1136/jcp.13.6.478. |
| 21703177 | Background | 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. |
| 27617496 | Derived | van Rijnsoever M, Galhenage S, Mollison L, Gummer J, Trengove R, Olynyk JK. Dysregulated Erythropoietin, Hepcidin, and Bone Marrow Iron Metabolism Contribute to Interferon-Induced Anemia in Hepatitis C. J Interferon Cytokine Res. 2016 Nov;36(11):630-634. doi: 10.1089/jir.2016.0043. Epub 2016 Sep 12. |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |