Clinical trial NCT01609049: An Observational Study of Peginterferon Alfa-2a in Combination With Ribavirin in Participants With Chronic Hepatitis C and Compensated Liver Cirrhosis
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-05-31
Enrollment: 1496
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with chronic hepatitis C and compensated liver cirrhosis (Class A by Child-Pugh scale) initiating treatment with Peginterferon alfa-2a and ribavirin

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline up to 24 Weeks Post Therapy Completion (approximately 3.5 years)
Secondary outcomes:
measure: Percentage of Naive Participants With Sustained Virological Response (SVR)) and Negative HCV RNA (< 50 IU/mL) at Week 4 and 12
timeFrame: Week 4, 12
measure: Percentage of Previously Treated Participants With SVR and Negative HCV RNA (< 50 IU/mL) at Week 12
timeFrame: Week 12
measure: 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
timeFrame: Baseline, Week 12
measure: Percentage of Naive Participants With SVR and Decrease in HCV RNA by >/= 2 Logarithm 10 From Baseline at Week 12
timeFrame: Baseline, Week 12
measure: Percentage of Previously Treated Participants With SVR, Decrease in HCV RNA by Negative HCV RNA (<50 IU/mL) at Week 24
timeFrame: Week 24
measure: Percentage of Naive Participants With SVR, Decrease in HCV RNA by Negative HCV RNA (<50 IU/mL) at Week 24
timeFrame: Week 24
measure: Percentage of Participants With SVR and Dose Reduction of Ribavirin or Peginterferon alfa-2a due to Adverse Event
timeFrame: Baseline up to approximately 3.5 years
measure: Percentage of Participants With Adverse Events
timeFrame: Baseline up to approximately 3.5 years
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Dongnam Inst.of Radiological & Medical Sciences
city: Barnaul
country: Russian Federation
facility: Altay Region Aids Center
city: Barnaul
country: Russian Federation
facility: Barnaul City Hospital #5; Therapy
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk State Medical Academy; Infectious Diseases
city: Chita
country: Russian Federation
facility: Chita State Medical Academy
city: Ekaterinburg
country: Russian Federation
facility: Ekaterinburg Regional Hospital #1; Gastroenterology
city: Irkutsk
country: Russian Federation
facility: Irkutsk Regional Consulting and Diagnostic Clinical Center; Regional Center of Reumatolodic Deasise
city: Kaluga
country: Russian Federation
facility: Kaluga regional AIDS center
city: Kazan
country: Russian Federation
facility: Kazan State Medical University
city: Kemerovo
country: Russian Federation
facility: Kemerovo City Infectious Clinical Hospital; Infectious
city: Khabarovsk
country: Russian Federation
facility: Khabarovsk-1 Road Clinical Hospital; Gastroenterology
city: Khabarovsk
country: Russian Federation
facility: Aids Center; Infectious
city: Kirov
country: Russian Federation
facility: Kirov Region Aids-Center; Infectious
city: Krasnodar
country: Russian Federation
facility: Clinical Center for the Prevention and Control of AIDS and Infectious Diseases
city: Krasnodar
country: Russian Federation
facility: Specialized clinical infectious hospital
city: Krasnoyarsk
country: Russian Federation
facility: Region Cinical Hospital; Gastroenterology
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk Region Aids Center; Hepatology
city: Lipetsk
country: Russian Federation
facility: Lipetsk Region Aids Center
city: Moscow
country: Russian Federation
facility: The scientific-research institute of epidemiology
city: Moscow
country: Russian Federation
facility: Central Medicosanitary Dept #165
city: Moscow
country: Russian Federation
facility: Russian Uni of People'S Friendship, Med. Faculty; City Clinical Hospital No 64, Internal Diseases
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital of RAS ; HEPATOLOGY
city: Moscow
country: Russian Federation
facility: FGBU "Polyclinic #1 Administration President RF
city: Moscow
country: Russian Federation
facility: I.M. Sechenov First Moscow State Medical University, The V.H.Vasilenko Clinic
city: Moscow
country: Russian Federation
facility: I.M. Sechenov First Moscow State Medical University: The E.M. Tareyev Clinic
city: Moscow
country: Russian Federation
facility: Hosital of Infectious Disease #1
city: Moscow
country: Russian Federation
facility: State Medical Stomatological Uni ; Infectious
city: Moscow
country: Russian Federation
facility: Russian Medical Academy of Postgraduate Education on Botkin S.P. ; City Clinical Hospital
city: Moscow
country: Russian Federation
facility: City Hospital # 24; Hepatology
city: Moscow
country: Russian Federation
facility: Clinical hospital Centrosouz
city: Moscow
country: Russian Federation
facility: 3-D Military Clinical Hospital
city: Moscow
country: Russian Federation
facility: Medelitconsulting; Medical
city: Nizniy Novgorod
country: Russian Federation
facility: AIDS Center
city: Novosibirsk
country: Russian Federation
facility: Infections Deseases Hospital #1
city: Petrozavodsk
country: Russian Federation
facility: Baranov Republican Hospital
city: Rostov-na-donu
country: Russian Federation
facility: City Hospital #1 After Semashko N.A.
city: Rostov-na-donu
country: Russian Federation
facility: Rostov State Medical Uni ; Infectious Diseases
city: Rostov-na-donu
country: Russian Federation
facility: City Hospital #2; Nefrology
city: Ryazan
country: Russian Federation
facility: Ryazan State Medical University Named after I.P.Pavlov
city: Saint-Petersburg
country: Russian Federation
facility: City polyclinic №107
city: Saint-Petersburg
country: Russian Federation
facility: Research institute of influenza named after I.I.Mechnikov
city: Samara
country: Russian Federation
facility: Samara State Medical Uni ; Hepatogastroenterology
city: Samara
country: Russian Federation
facility: MC Gepatolog
city: Saratov
country: Russian Federation
facility: City Clinical Hospital №2; Infectional diseases department
city: Saratov
country: Russian Federation
facility: Saratov Region Aids Center; Infectious Diseases
city: St Petersburg
country: Russian Federation
facility: Military Medical Academy; Infectious Deseases
city: St Petersburg
country: Russian Federation
facility: St. Petersburg Aids Center; Haepatology
city: St. Petersburg
country: Russian Federation
facility: S.P. Botkin Clinical Infectious Disease Hospital
city: Stavropol
country: Russian Federation
facility: Stavropol State Medical Academy
city: Tumen
country: Russian Federation
facility: Consulting diagnostic center
city: UFA
country: Russian Federation
facility: State Medical Uni of Republic Bashkortostan; Infection Diseases
city: Vladivostok
country: Russian Federation
facility: Vladivostok state medical university
city: Vladivostok
country: Russian Federation
facility: MUZ City Clinical Infectional Hospital
city: Volgograd
country: Russian Federation
facility: Volgograd Regional Aids Center For Aids and Infectious Diseases T Volgograd
city: Voronezh
country: Russian Federation
facility: Regional Clinical Hospital of Infectious Diseases
city: Yakutsk
country: Russian Federation
facility: Yakutsk City Hospital
city: Yoshkar-Ola
country: Russian Federation
facility: National Center for Prevention and Control of AIDS and Infectious Diseases
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: