An Observational Study of Peginterferon Alfa-2a in Combination With Ribavirin in Participants With Chronic Hepatitis C and Compensated Liver Cirrhosis
- Registration Number
- NCT01609049
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1496
- 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
- Human immunodeficiency virus (HIV) co-infection
- Contraindications for combined therapy according to actual prescribing information
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants with Chronic Hepatitis C Ribavirin Naive and previously treated participants who received peginterferon alfa-2a in combination with ribavirin as per local labeling requirements. Participants with Chronic Hepatitis C Peginterferon alfa-2a Naive and previously treated participants who received peginterferon alfa-2a in combination with ribavirin as per local labeling requirements.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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
Trial Locations
- Locations (57)
Kirov Region Aids-Center; Infectious
🇷🇺Kirov, Russian Federation
Infections Deseases Hospital #1
🇷🇺Novosibirsk, Russian Federation
Krasnoyarsk Region Aids Center; Hepatology
🇷🇺Krasnoyarsk, Russian Federation
Baranov Republican Hospital
🇷🇺Petrozavodsk, Russian Federation
City polyclinic â„–107
🇷🇺Saint-Petersburg, Russian Federation
Samara State Medical Uni ; Hepatogastroenterology
🇷🇺Samara, Russian Federation
3-D Military Clinical Hospital
🇷🇺Moscow, Russian Federation
Altay Region Aids Center
🇷🇺Barnaul, Russian Federation
Chelyabinsk State Medical Academy; Infectious Diseases
🇷🇺Chelyabinsk, Russian Federation
Specialized clinical infectious hospital
🇷🇺Krasnodar, Russian Federation
Saratov Region Aids Center; Infectious Diseases
🇷🇺Saratov, Russian Federation
Barnaul City Hospital #5; Therapy
🇷🇺Barnaul, Russian Federation
Kemerovo City Infectious Clinical Hospital; Infectious
🇷🇺Kemerovo, 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
Central Medicosanitary Dept #165
🇷🇺Moscow, Russian Federation
Hosital of Infectious Disease #1
🇷🇺Moscow, Russian Federation
Ekaterinburg Regional Hospital #1; Gastroenterology
🇷🇺Ekaterinburg, Russian Federation
Region Cinical Hospital; Gastroenterology
🇷🇺Krasnoyarsk, Russian Federation
Lipetsk Region Aids Center
🇷🇺Lipetsk, Russian Federation
City Hospital #1 After Semashko N.A.
🇷🇺Rostov-na-donu, Russian Federation
City Clinical Hospital â„–2; Infectional diseases department
🇷🇺Saratov, Russian Federation
St. Petersburg Aids Center; Haepatology
🇷🇺St Petersburg, Russian Federation
Stavropol State Medical Academy
🇷🇺Stavropol, Russian Federation
Vladivostok state medical university
🇷🇺Vladivostok, Russian Federation
The scientific-research institute of epidemiology
🇷🇺Moscow, Russian Federation
FGBU "Polyclinic #1 Administration President RF
🇷🇺Moscow, Russian Federation
State Medical Stomatological Uni ; Infectious
🇷🇺Moscow, Russian Federation
City Hospital # 24; Hepatology
🇷🇺Moscow, Russian Federation
Clinical hospital Centrosouz
🇷🇺Moscow, Russian Federation
Medelitconsulting; Medical
🇷🇺Moscow, Russian Federation
S.P. Botkin Clinical Infectious Disease Hospital
🇷🇺St. Petersburg, Russian Federation
Kaluga regional AIDS center
🇷🇺Kaluga, Russian Federation
Chita State Medical Academy
🇷🇺Chita, Russian Federation
Irkutsk Regional Consulting and Diagnostic Clinical Center; Regional Center of Reumatolodic Deasise
🇷🇺Irkutsk, Russian Federation
Russian Uni of People'S Friendship, Med. Faculty; City Clinical Hospital No 64, Internal Diseases
🇷🇺Moscow, Russian Federation
Clinical Center for the Prevention and Control of AIDS and Infectious Diseases
🇷🇺Krasnodar, Russian Federation
Khabarovsk-1 Road Clinical Hospital; Gastroenterology
🇷🇺Khabarovsk, Russian Federation
I.M. Sechenov First Moscow State Medical University: The E.M. Tareyev Clinic
🇷🇺Moscow, Russian Federation
City Hospital #2; Nefrology
🇷🇺Rostov-na-donu, Russian Federation
MC Gepatolog
🇷🇺Samara, Russian Federation
State Medical Uni of Republic Bashkortostan; Infection Diseases
🇷🇺UFA, Russian Federation
National Center for Prevention and Control of AIDS and Infectious Diseases
🇷🇺Yoshkar-Ola, Russian Federation
Military Medical Academy; Infectious Deseases
🇷🇺St Petersburg, Russian Federation
Consulting diagnostic center
🇷🇺Tumen, Russian Federation
Regional Clinical Hospital of Infectious Diseases
🇷🇺Voronezh, Russian Federation
Volgograd Regional Aids Center For Aids and Infectious Diseases T Volgograd
🇷🇺Volgograd, Russian Federation
MUZ City Clinical Infectional Hospital
🇷🇺Vladivostok, Russian Federation
Yakutsk City Hospital
🇷🇺Yakutsk, Russian Federation
Dongnam Inst.of Radiological & Medical Sciences
🇰🇷Busan, Korea, Republic of
Kazan State Medical University
🇷🇺Kazan, Russian Federation
Aids Center; Infectious
🇷🇺Khabarovsk, Russian Federation
Central Clinical Hospital of RAS ; HEPATOLOGY
🇷🇺Moscow, Russian Federation
I.M. Sechenov First Moscow State Medical University, The V.H.Vasilenko Clinic
🇷🇺Moscow, Russian Federation
Russian Medical Academy of Postgraduate Education on Botkin S.P. ; City Clinical Hospital
🇷🇺Moscow, Russian Federation
AIDS Center
🇷🇺Nizniy Novgorod, Russian Federation
Research institute of influenza named after I.I.Mechnikov
🇷🇺Saint-Petersburg, Russian Federation