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| Name | Class |
|---|---|
| Samsung Medical Center | OTHER |
| Severance Hospital | OTHER |
| Gangnam Severance Hospital | OTHER |
| Seoul St. Mary's Hospital |
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The purpose of this study is to investigate the efficacy and effectiveness of peginterferon alfa-2a and ribavirin therapy in Korean chronic hepatitis C patients.
A retrospective analysis of a prospective, multicenter, industry-sponsored, open-label, uncontrolled, community-based clinical trial of combination of peginterferon alfa-2a and ribavirin (Pegasys Expanded Access Program) conducted at 6 tertiary referral centers in Korea between 2003 and 2004 and a cohort of hepatitis C patients who were treated in a single tertiary referral hospital (Asan Medical Center, Seoul, Korea) between 2004 and 2008
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Korean CHC | Experimental | Two CHC patient groups. One is CHC patients who are treated with combination of peginterferon alfa-2a and ribavirin in a prospective, multicenter, industry-sponsored, open-label, uncontrolled, community-based clinical trial (Pegasys Expanded Access Program) conducted at 6 tertiary referral centers in Korea between 2003 and 2004. Another is a cohort of hepatitis C patients who were treated in a single tertiary referral hospital (Asan Medical Center, Seoul, Korea) between 2004 and 2008. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2a plus ribavirin for HCV genotype 1 | Drug | Patients with genotype 1: treatment with peginterferon α-2a (Roche, Basel, Switzerland) 180 μg/week and daily ribavirin dose of 1,000 mg (for patients with body weight <75kg) or 1,200 mg (for patients with body weight ≥75kg) for 48 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients achieving sustained virological response (SVR) | SVR is defined as a documented undetectable serum HCV RNA by PCR at 24 weeks after cessation of treatment | at 24 weeks after cessation of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients achieving early virological response (EVR) | EVR is defined as reduction of HCV RNA level by 2 log or more at 12 weeks of treatment | at 12 weeks of treatment |
| the proportion of patients achieving complete EVR (cEVR) |
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Inclusion Criteria: all of below
Exclusion Criteria: any of below
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| Name | Affiliation | Role |
|---|---|---|
| Young-Suk Lim, M.D., Ph.D. | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | 138-736 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23593611 | Derived | Heo NY, Lim YS, Lee HC, Lee YS, Kim KM, Byun KS, Han KH, Lee KS, Paik SW, Yoon SK, Suh DJ. High effectiveness of peginterferon alfa-2a plus ribavirin therapy in Korean patients with chronic hepatitis C in clinical practice. Clin Mol Hepatol. 2013 Mar;19(1):60-9. doi: 10.3350/cmh.2013.19.1.60. Epub 2013 Mar 25. |
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| OTHER |
| Korea University Guro Hospital | OTHER |
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|
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| Peginterferon alfa-2a plus ribavirin for HCV genotype 2/3 | Drug | Patients with genotype 2 or 3: treatment with peginterferon α-2a 180 μg/week and daily ribavirin dose of 800 mg for 24 weeks. |
|
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cEVR is defined as HCV RNA undetectable by PCR at 12 weeks of treatment
| at 12 weeks of treatment |
| The proportion of patients achieving end-of-treatment response (ETR) | ETR is defined as HCV RNA undetectable at the end of treatment. | at week 48 for HCV genotype 1 and at week 24 for HCV genotype 2/3 |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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