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This prospective observational study will evaluate the efficacy and safety of peginterferon alfa-2a in combination with ribavirin in participants with chronic hepatitis C, including participants with compensated liver cirrhosis, in clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Chronic Hepatitis C | Naive and previously treated participants who received peginterferon alfa-2a in combination with ribavirin as per local labeling requirements. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2a | Drug | Administration of treatment will be according to local recommendation under local labeling. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) (less than [<] 50 International Units per Milliliter [IU/mL]) 24 Weeks Post Therapy Completion | Baseline up to 24 Weeks Post Therapy Completion (approximately 3.5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Naive Participants With Sustained Virological Response (SVR)) and Negative HCV RNA (< 50 IU/mL) at Week 4 and 12 | Week 4, 12 | |
| Percentage of Previously Treated Participants With SVR and Negative HCV RNA (< 50 IU/mL) at Week 12 | Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with chronic hepatitis C and compensated liver cirrhosis (Class A by Child-Pugh scale) initiating treatment with Peginterferon alfa-2a and ribavirin
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altay Region Aids Center | Barnaul | 656010 | Russia | |||
| Barnaul City Hospital #5; Therapy |
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| Ribavirin | Drug | Ribavirin tablets twice daily orally will be administered depending on body weight, according summary product characteristics and prescribing of ribavirin in real clinical practice. |
|
|
| Percentage of Previously Treated Participants With SVR and Decrease in HCV RNA by Greater Than or Equal to (>/=) 2 Logarithm 10 From Baseline at Week 12 | Baseline, Week 12 |
| Percentage of Naive Participants With SVR and Decrease in HCV RNA by >/= 2 Logarithm 10 From Baseline at Week 12 | Baseline, Week 12 |
| Percentage of Previously Treated Participants With SVR, Decrease in HCV RNA by Negative HCV RNA (<50 IU/mL) at Week 24 | Week 24 |
| Percentage of Naive Participants With SVR, Decrease in HCV RNA by Negative HCV RNA (<50 IU/mL) at Week 24 | Week 24 |
| Percentage of Participants With SVR and Dose Reduction of Ribavirin or Peginterferon alfa-2a due to Adverse Event | Baseline up to approximately 3.5 years |
| Percentage of Participants With Adverse Events | Baseline up to approximately 3.5 years |
| Barnaul |
| 656045 |
| Russia |
| Chelyabinsk State Medical Academy; Infectious Diseases | Chelyabinsk | 454052 | Russia |
| Chita State Medical Academy | Chita | 672090 | Russia |
| Irkutsk Regional Consulting and Diagnostic Clinical Center; Regional Center of Reumatolodic Deasise | Irkutsk | 664047 | Russia |
| Kaluga regional AIDS center | Kaluga | 248023 | Russia |
| Kazan State Medical University | Kazan' | 420012 | Russia |
| Kemerovo City Infectious Clinical Hospital; Infectious | Kemerovo | 650036 | Russia |
| Khabarovsk-1 Road Clinical Hospital; Gastroenterology | Khabarovsk | 680022 | Russia |
| Aids Center; Infectious | Khabarovsk | 680031 | Russia |
| Kirov Region Aids-Center; Infectious | Kirov | 610000 | Russia |
| Clinical Center for the Prevention and Control of AIDS and Infectious Diseases | Krasnodar | 350015 | Russia |
| Specialized clinical infectious hospital | Krasnodar | 350015 | Russia |
| Region Cinical Hospital; Gastroenterology | Krasnoyarsk | 660022 | Russia |
| Krasnoyarsk Region Aids Center; Hepatology | Krasnoyarsk | 660049 | Russia |
| Lipetsk Region Aids Center | Lipetsk | 398043 | Russia |
| The scientific-research institute of epidemiology | Moscow | 111123 | Russia |
| Central Medicosanitary Dept #165 | Moscow | 115201 | Russia |
| Russian Uni of People'S Friendship, Med. Faculty; City Clinical Hospital No 64, Internal Diseases | Moscow | 117292 | Russia |
| Central Clinical Hospital of RAS ; HEPATOLOGY | Moscow | 117333 | Russia |
| FGBU "Polyclinic #1 Administration President RF | Moscow | 119002 | Russia |
| I.M. Sechenov First Moscow State Medical University, The V.H.Vasilenko Clinic | Moscow | 119881 | Russia |
| I.M. Sechenov First Moscow State Medical University: The E.M. Tareyev Clinic | Moscow | 119992 | Russia |
| Hosital of Infectious Disease #1 | Moscow | 123367 | Russia |
| State Medical Stomatological Uni ; Infectious | Moscow | 123367 | Russia |
| Russian Medical Academy of Postgraduate Education on Botkin S.P. ; City Clinical Hospital | Moscow | 125101 | Russia |
| City Hospital # 24; Hepatology | Moscow | 127009 | Russia |
| Clinical hospital Centrosouz | Moscow | 129110 | Russia |
| 3-D Military Clinical Hospital | Moscow | 143420 | Russia |
| Medelitconsulting; Medical | Moscow | Russia |
| AIDS Center | Nizniy Novgorod | 603005 | Russia |
| Infections Deseases Hospital #1 | Novosibirsk | 630016 | Russia |
| Baranov Republican Hospital | Petrozavodsk | 185019 | Russia |
| City Hospital #1 After Semashko N.A. | Rostov-on-Don | 344010 | Russia |
| Rostov State Medical Uni ; Infectious Diseases | Rostov-on-Don | 344022 | Russia |
| City Hospital #2; Nefrology | Rostov-on-Don | 344029 | Russia |
| Ryazan State Medical University Named after I.P.Pavlov | Ryazan | 390011 | Russia |
| S.P. Botkin Clinical Infectious Disease Hospital | Saint Petersburg | 191167 | Russia |
| Military Medical Academy; Infectious Deseases | Saint Petersburg | 194044 | Russia |
| City polyclinic №107 | Saint Petersburg | 195030 | Russia |
| Research institute of influenza named after I.I.Mechnikov | Saint Petersburg | 197376 | Russia |
| St. Petersburg Aids Center; Haepatology | Saint Petersburg | 198103 | Russia |
| Samara State Medical Uni ; Hepatogastroenterology | Samara | 443021 | Russia |
| MC Gepatolog | Samara | 443100 | Russia |
| City Clinical Hospital №2; Infectional diseases department | Saratov | 410028 | Russia |
| Saratov Region Aids Center; Infectious Diseases | Saratov | 410040 | Russia |
| Stavropol State Medical Academy | Stavropol | 355017 | Russia |
| Consulting diagnostic center | Tyumen | 625026 | Russia |
| State Medical Uni of Republic Bashkortostan; Infection Diseases | Ufa | 450000 | Russia |
| Vladivostok state medical university | Vladivostok | 690002 | Russia |
| MUZ City Clinical Infectional Hospital | Vladivostok | 690065 | Russia |
| Volgograd Regional Aids Center For Aids and Infectious Diseases T Volgograd | Volgograd | 400040 | Russia |
| Regional Clinical Hospital of Infectious Diseases | Voronezh | 394030 | Russia |
| Yakutsk City Hospital | Yakutsk | 677019 | Russia |
| Ekaterinburg Regional Hospital #1; Gastroenterology | Yekaterinburg | 620102 | Russia |
| National Center for Prevention and Control of AIDS and Infectious Diseases | Yoshkar-Ola | 424037 | Russia |
| Dongnam Inst.of Radiological & Medical Sciences | Busan | 46033 | 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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