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| Name | Class |
|---|---|
| Severance Hospital | OTHER |
| Pusan National University Hospital | OTHER |
| Incheon St.Mary's Hospital | OTHER |
| Soon Chun Hyang University |
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This study aim to evaluate the non-inferiority of sustained virologic response in peginterferon alfa-2a and weight-based ribavirin for 16 weeks compare with standard treatment duration of 24 weeks in patients who achieved rapid virologic response with genotype 2 CHC.
In recent study (the ACCELERATE trial), treatment with peginterferon alfa-2a and ribavirin (800mg/day) for 16 weeks in patients infected with HCV genotype 2 or 3 result in a lower overall sustained virologic response rate than treatment with the standard 24 weeks regimen. Ribavirin was used as a flat dose (800mg/day) in ACCELERATE trial. But, previous studies which used the weight-based dose of ribavirin (800-1400mg/day) had shown that a treatment duration of 16 weeks was as effective as 24 weeks regimen in HCV genotype 2 patients with a RVR. But, there was too small number of patient enrolled study to argue logically about ACCELERATE trial. In this study, we aimed to confirm the non-inferiority peginterferon alfa-2a and weight-based ribavirin for 16 weeks compare with standard treatment duration of 24 weeks in patients who achieved rapid virologic response with genotype 2 CHC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A. 24 weeks in RVR patients. | Active Comparator | Peginterferon alfa-2a and weight-based ribavirin (800-1200mg/day) for 24 weeks in patients with RVR. |
|
| B. 16 weeks in RVR patients. | Experimental | Peginterferon alfa-2a and weight-based ribavirin (800-1200mg/day) for 16 weeks in patients with RVR. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2a and Ribavirin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sustained virologic response (SVR) | 24 weeks post-treatment (week 40 or week 48) |
| Measure | Description | Time Frame |
|---|---|---|
| AEs |
| up to 24 weeks after last treatment visit |
| laboratory parameters |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ki Tae Yoon, M.D | Contact | +82-55-360-2362 | ktyoon@pusan.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Ki Tae Yoon, M.D | Pusan National University Yangsan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Yangsan Hospital | Recruiting | Yangsan | Gyeongsangnam-do | 626-770 | South Korea |
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| OTHER |
| Inje University | OTHER |
| Inje University Ilsan Paik Hospital | OTHER |
| Inje University Haeundae Paik Hospital | OTHER |
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| Peginterferon alfa-2a and Ribavirin | Drug |
|
|
| up to 24 weeks after last treatment visit |
| vital signs |
| up to 24 weeks after last treatment visit |
| Soon Chun Hyang University Bucheon Hospital | Recruiting | Bucheon-si | 420-767 | South Korea |
|
| Pusan National University Hospital | Recruiting | Busan | 602-739 | South Korea |
|
| Inje University Pusan Paik Hospital | Recruiting | Busan | 633-165 | South Korea |
|
| Inje University Haeundae Paik Hospital | Recruiting | Busan | South Korea |
|
| Inje University Ilsan Paik Hospital | Active, not recruiting | Goyang | South Korea |
| Incheon St. Mary's Hospital | Recruiting | Incheon | South Korea |
|
| Severance Hospital | Recruiting | Seoul | 120-752 | South Korea |
|
| 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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