Hepatitis C, Chronic Clinical Trial
— STANDARTOfficial title:
Open-label, Multicenter, Non-Comparative, Prospective Observational Study to Evaluate Efficacy and Safety of Combined Ribavirin and Peginterferon Alfa-2a (40 kDa) Therapy in Patients With Chronic Hepatitis C (CHC) or Compensated Liver Cirrhosis in Real Clinical Practice
| Verified date | April 2017 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 1496 |
| Est. completion date | June 22, 2015 |
| Est. primary completion date | June 22, 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Serologically confirmed chronic hepatitis C (CHC), hepatitis C virus (HCV) RNA detectable - Compensated liver cirrhosis (Child-Pugh Class A) included - Initiating combined therapy with peginterferon alfa-2a and ribavirin Exclusion Criteria: - Human immunodeficiency virus (HIV) co-infection - Contraindications for combined therapy according to actual prescribing information |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Dongnam Inst.of Radiological & Medical Sciences | Busan | |
| Russian Federation | Altay Region Aids Center | Barnaul | |
| Russian Federation | Barnaul City Hospital #5; Therapy | Barnaul | |
| Russian Federation | Chelyabinsk State Medical Academy; Infectious Diseases | Chelyabinsk | |
| Russian Federation | Chita State Medical Academy | Chita | |
| Russian Federation | Ekaterinburg Regional Hospital #1; Gastroenterology | Ekaterinburg | |
| Russian Federation | Irkutsk Regional Consulting and Diagnostic Clinical Center; Regional Center of Reumatolodic Deasise | Irkutsk | |
| Russian Federation | Kaluga regional AIDS center | Kaluga | |
| Russian Federation | Kazan State Medical University | Kazan | |
| Russian Federation | Kemerovo City Infectious Clinical Hospital; Infectious | Kemerovo | |
| Russian Federation | Aids Center; Infectious | Khabarovsk | |
| Russian Federation | Khabarovsk-1 Road Clinical Hospital; Gastroenterology | Khabarovsk | |
| Russian Federation | Kirov Region Aids-Center; Infectious | Kirov | |
| Russian Federation | Clinical Center for the Prevention and Control of AIDS and Infectious Diseases | Krasnodar | |
| Russian Federation | Specialized clinical infectious hospital | Krasnodar | |
| Russian Federation | Krasnoyarsk Region Aids Center; Hepatology | Krasnoyarsk | |
| Russian Federation | Region Cinical Hospital; Gastroenterology | Krasnoyarsk | |
| Russian Federation | Lipetsk Region Aids Center | Lipetsk | |
| Russian Federation | 3-D Military Clinical Hospital | Moscow | |
| Russian Federation | Central Clinical Hospital of RAS ; HEPATOLOGY | Moscow | |
| Russian Federation | Central Medicosanitary Dept #165 | Moscow | |
| Russian Federation | City Hospital # 24; Hepatology | Moscow | |
| Russian Federation | Clinical hospital Centrosouz | Moscow | |
| Russian Federation | FGBU "Polyclinic #1 Administration President RF | Moscow | |
| Russian Federation | Hosital of Infectious Disease #1 | Moscow | |
| Russian Federation | I.M. Sechenov First Moscow State Medical University, The V.H.Vasilenko Clinic | Moscow | |
| Russian Federation | I.M. Sechenov First Moscow State Medical University: The E.M. Tareyev Clinic | Moscow | |
| Russian Federation | Medelitconsulting; Medical | Moscow | |
| Russian Federation | Russian Medical Academy of Postgraduate Education on Botkin S.P. ; City Clinical Hospital | Moscow | |
| Russian Federation | Russian Uni of People'S Friendship, Med. Faculty; City Clinical Hospital No 64, Internal Diseases | Moscow | |
| Russian Federation | State Medical Stomatological Uni ; Infectious | Moscow | |
| Russian Federation | The scientific-research institute of epidemiology | Moscow | |
| Russian Federation | AIDS Center | Nizniy Novgorod | |
| Russian Federation | Infections Deseases Hospital #1 | Novosibirsk | |
| Russian Federation | Baranov Republican Hospital | Petrozavodsk | |
| Russian Federation | City Hospital #1 After Semashko N.A. | Rostov-na-donu | |
| Russian Federation | City Hospital #2; Nefrology | Rostov-na-donu | |
| Russian Federation | Rostov State Medical Uni ; Infectious Diseases | Rostov-na-donu | |
| Russian Federation | Ryazan State Medical University Named after I.P.Pavlov | Ryazan | |
| Russian Federation | City polyclinic ?107 | Saint-Petersburg | |
| Russian Federation | Research institute of influenza named after I.I.Mechnikov | Saint-Petersburg | |
| Russian Federation | MC Gepatolog | Samara | |
| Russian Federation | Samara State Medical Uni ; Hepatogastroenterology | Samara | |
| Russian Federation | City Clinical Hospital ?2; Infectional diseases department | Saratov | |
| Russian Federation | Saratov Region Aids Center; Infectious Diseases | Saratov | |
| Russian Federation | Military Medical Academy; Infectious Deseases | St Petersburg | |
| Russian Federation | St. Petersburg Aids Center; Haepatology | St Petersburg | |
| Russian Federation | S.P. Botkin Clinical Infectious Disease Hospital | St. Petersburg | |
| Russian Federation | Stavropol State Medical Academy | Stavropol | |
| Russian Federation | Consulting diagnostic center | Tumen | |
| Russian Federation | State Medical Uni of Republic Bashkortostan; Infection Diseases | UFA | |
| Russian Federation | MUZ City Clinical Infectional Hospital | Vladivostok | |
| Russian Federation | Vladivostok state medical university | Vladivostok | |
| Russian Federation | Volgograd Regional Aids Center For Aids and Infectious Diseases T Volgograd | Volgograd | |
| Russian Federation | Regional Clinical Hospital of Infectious Diseases | Voronezh | |
| Russian Federation | Yakutsk City Hospital | Yakutsk | |
| Russian Federation | National Center for Prevention and Control of AIDS and Infectious Diseases | Yoshkar-Ola |
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
Korea, Republic of, Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | ||
| Secondary | Percentage of Naive Participants With Sustained Virological Response (SVR)) and Negative HCV RNA (< 50 IU/mL) at Week 4 and 12 | Week 4, 12 | ||
| Secondary | Percentage of Previously Treated Participants With SVR and Negative HCV RNA (< 50 IU/mL) at Week 12 | Week 12 | ||
| Secondary | 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 | ||
| Secondary | Percentage of Naive Participants With SVR and Decrease in HCV RNA by >/= 2 Logarithm 10 From Baseline at Week 12 | Baseline, Week 12 | ||
| Secondary | Percentage of Previously Treated Participants With SVR, Decrease in HCV RNA by Negative HCV RNA (<50 IU/mL) at Week 24 | Week 24 | ||
| Secondary | Percentage of Naive Participants With SVR, Decrease in HCV RNA by Negative HCV RNA (<50 IU/mL) at Week 24 | Week 24 | ||
| Secondary | 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 | ||
| Secondary | Percentage of Participants With Adverse Events | Baseline up to approximately 3.5 years |
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