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| Name | Class |
|---|---|
| Ulsan University Hospital | OTHER |
| National Health Insurance Service Ilsan Hospital | OTHER |
| Inje University | OTHER |
| Soonchunhyang University Hospital |
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The virologic response of Koreans to combination therapy for chronic hepatitis C is similar to non-Asians; however, dose modification occurs more frequently in Koreans.
-When we evaluated the rates of peginterferon α-2a and ribavirin dose modifications and their effect on the virologic response in Koreans, we suggested that using at least 80% of the peginterferon α-2a dose in Koreans not only maintains SVR but also reduces drug side effects during the entire treatment period and a lower dose of ribavirin may be as efficacious as a standard dose(Korean J Intern Med 2009;24:203-211).
So we investigate whether the group of 80% use dosage of peginterferon alfa-2a did not show inferior response rather than that of 100 % use dosage group and minimize the adverse events.
There are recently reports that Koreans have favorable IL28B SNP for CHC treatment.
-We investigate the IL28B polymorphism in Koreans with CHC and this result can effect on the SVR depending on the dosage of peginterferon alfa 2a
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 80% dosage group of peginterferon alfa 2a | Experimental | This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment. |
|
| 100% dosage group of peginterferon alfa 2a | Active Comparator | These group patients would be treated with standard dose 180 ug/week for 48 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peginterferon alfa 2a (pegasys) | Drug | dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Virologic Response Depending on the Dosage of Peginterferon Alfa 2a | We investigate whether the SVR between 100% and 80% group of peginterferon alfa 2a is not different. | post treatment 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| IL28B Polymorphism Effect on SVR | We additionally investigate the IL28B polymorphism and this result can effect on the SVR depending on dosage of peginterferon alfa-2a. | post treatment 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jung Hyun Kwon, MD, Assistant professor | The Catholic University of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soonchunghyang University Hospital | Bucheon-si | South Korea | ||||
| Hallym University Chunchun Medical center |
no excluded patients before assignment to groups
enrollment date : 2009-2011 recruitment period : 2009-2012 type location: 14 university hospital
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| ID | Title | Description |
|---|---|---|
| FG000 | 100% Dosage Group of Peginterferon Alfa 2a | These group patients would be treated with standard dose 180 ug/week for 48 weeks. peginterferon alfa-2a (pegasys) : These patients would be treated with standard dose 180ug /week for 48 weeks. In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| OTHER |
| Yonsei University | OTHER |
| Chungnam National University | OTHER |
| Keimyung University | OTHER |
| Kyungpook National University Hospital | OTHER |
| Konyang University Hospital | OTHER |
| Inha University Hospital | OTHER |
| Hallym University Medical Center | OTHER |
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|
| peginterferon alfa-2a (pegasys) | Drug | These patients would be treated with standard dose 180ug /week for 48 weeks. In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose. |
|
|
| Chunchun |
| South Korea |
| Keimyung University hospital | Daegu | South Korea |
| Kyungpook National University Hospital | Daegu | South Korea |
| Ghungnam National University hospital | Daejun | South Korea |
| Konyang University hospital | Daejun | South Korea |
| Incheon St. Mary's Hospital | Incheon | South Korea |
| Inha University hospital | Incheon | South Korea |
| Inje University, Ilsan Paik Hospital | Koyang-si | South Korea |
| NHIC Ilsan hospital | Koyang-si | South Korea |
| Inje University, Pusan Paik Hospital | Pusan | South Korea |
| Seoul St. Mary's Hospital, The Catholic University of Korea | Seoul | South Korea |
| Ulsan university | Ulsan | South Korea |
| Yonsei University, Wonju Hospital | Wŏnju | South Korea |
| FG001 | 80% Dosage Group of Peginterferon Alfa 2a | This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment. peginterferon alfa 2a (pegasys) : dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 100% Dosage Group of Peginterferon Alfa 2a | These group patients would be treated with standard dose 180 ug/week for 48 weeks. peginterferon alfa-2a (pegasys) : These patients would be treated with standard dose 180ug /week for 48 weeks. In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose. |
| BG001 | 80% Dosage Group of Peginterferon Alfa 2a | This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment. peginterferon alfa 2a (pegasys) : dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sustained Virologic Response Depending on the Dosage of Peginterferon Alfa 2a | We investigate whether the SVR between 100% and 80% group of peginterferon alfa 2a is not different. | We present the result of intention-to-treat analysis. | Posted | Number | participants who achieved SVR | post treatment 24 weeks |
|
|
| |||||||||||||||||||||||||||||
| Secondary | IL28B Polymorphism Effect on SVR | We additionally investigate the IL28B polymorphism and this result can effect on the SVR depending on dosage of peginterferon alfa-2a. | The patients who agreed to check the genotype were analysed. | Posted | Number | percentage of SVR | post treatment 24 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 100% Dosage Group of Peginterferon Alfa 2a | These group patients would be treated with standard dose 180 ug/week for 48 weeks. peginterferon alfa-2a (pegasys) : These patients would be treated with standard dose 180ug /week for 48 weeks. In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose. | 0 | 92 | 45 | 92 | ||
| EG001 | 80% Dosage Group of Peginterferon Alfa 2a | This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment. peginterferon alfa 2a (pegasys) : dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable | 0 | 86 | 49 | 86 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| laboratory adverse events | Blood and lymphatic system disorders | CBC | Systematic Assessment | Neutropenia, thrombocytopenia, anemia |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kwon | the Catholic University of Korea | +82322805886 | doctorkwon@catholic.ac.kr |
| 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 |
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| >=65 years |
|
| Male |
|
|