An Observational Study of Peginterferon Alfa-2a in Combination With Ribavirin in Participants With Chronic Hepatitis C and Compensated Liver Cirrhosis
STANDART
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
1 other identifier
observational
1,496
2 countries
57
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2011
Typical duration for all trials
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 7, 2011
CompletedFirst Submitted
Initial submission to the registry
May 29, 2012
CompletedFirst Posted
Study publicly available on registry
May 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 22, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 22, 2015
CompletedApril 12, 2017
April 1, 2017
3.5 years
May 29, 2012
April 11, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
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
- +3 more secondary outcomes
Study Arms (1)
Participants with Chronic Hepatitis C
Naive and previously treated participants who received peginterferon alfa-2a in combination with ribavirin as per local labeling requirements.
Interventions
Administration of treatment will be according to local recommendation under local labeling.
Ribavirin tablets twice daily orally will be administered depending on body weight, according summary product characteristics and prescribing of ribavirin in real clinical practice.
Eligibility Criteria
Participants with chronic hepatitis C and compensated liver cirrhosis (Class A by Child-Pugh scale) initiating treatment with Peginterferon alfa-2a and ribavirin
You may qualify if:
- 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
You may not qualify if:
- Human immunodeficiency virus (HIV) co-infection
- Contraindications for combined therapy according to actual prescribing information
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (57)
Altay Region Aids Center
Barnaul, 656010, Russia
Barnaul City Hospital #5; Therapy
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2012
First Posted
May 31, 2012
Study Start
December 7, 2011
Primary Completion
June 22, 2015
Study Completion
June 22, 2015
Last Updated
April 12, 2017
Record last verified: 2017-04