Clinical trial NCT01280656: A Retrospective Study to Assess the Impact of the Use of Interferon in Patients With Chronic Hepatitis C (DECISION)
Official title: Retrospective Study to Evaluate the Impact of Using Interferon (Pegylated or Not) in the Treatment of Patients With Chronic Hepatitis C in Brazil (DECISION)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-01-21
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hepatitis C patients that received interferon (pegylated or conventional) during the period stipulated (from 01-Sep-2007 to 31-Aug-2008)

Brief summary: This retrospective study will assess the sustained virologic response and the safety of two different interferons (pegylated or conventional) in patients with chronic hepatitis C. Data will be collected for 24 weeks.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/=18 years and \<70 years of age
* Diagnosis of hepatitis C
* Assessment of viral load prior to treatment (mandatory for genotype 1 only)
* Liver biopsy
* Co-morbidities data
* Use of interferon (pegylated or conventional) and ribavirin to treat hepatitis C infection genotype 2 and 3 and pegylated interferon plus ribavirin to treat hepatitis C infection genotype 1
* Above mentioned treatment started between 01-Sep-2007 and 31-Aug-2008

Exclusion Criteria:

* Co-infection with human immunodeficiency virus
* Co-infection with hepatitis B virus
* Presence of hepatocarcinoma
* Patients submitted to hemodialysis
* Organ transplant patients

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response at 12 Weeks After End of Treatment
timeFrame: At Week 60
Secondary outcomes:
measure: Percentage of Participants With Sustained Virologic Response at 24 Weeks After End of Treatment
timeFrame: At Week 72
measure: Number of Participants With Interferon Dose Reduction Rates in Function of the Interferon Type Being Used
timeFrame: At Week 24
measure: Percentage of Participants With Early Virologic Response at Week 12
timeFrame: At Week 12
measure: Percentage of Participants With Sustained Virologic Response Treated at Interferon Application Centers and Treated at Home
timeFrame: At Week 60 (SVR 12) and Week 72 (SVR 24)
measure: Percentage of Participants Who Were Treated at Interferon Application Centers and at Home and Discontinued Treatment
timeFrame: Up to Week 48
measure: Mean Percentage Reduction of Hemoglobin in Treatment Responders and Treatment Non-Responders
timeFrame: Up to Week 72
measure: Percentage of Participants With Rapid Virologic Response at Week 4
timeFrame: At Week 4
measure: Percentage of Participants With Virologic Response at End of Treatment
timeFrame: At Week 48
measure: Percentage of Participants With Virologic Relapse up to Week 72
timeFrame: Up to Week 72
measure: Percentage of Participants With Null Response or No Responder at End of Treatment
timeFrame: At Week 48
measure: Percentage of Participants Who Discontinued Treatment Due to Adverse Events
timeFrame: Up to Week 48
measure: Number of Participants With Any Adverse Events and Any Serious Adverse Events
timeFrame: Up to Week 72
Other outcomes:
Locations:
city: Rio Branco
country: Brazil
state: AC
city: Manaus
country: Brazil
state: AM
city: Salvador
country: Brazil
state: BA
city: Vitoria
country: Brazil
state: ES
city: Goiania
country: Brazil
state: GO
city: Sao Luis
country: Brazil
state: MA
city: Pouso Alegre
country: Brazil
state: MG
city: Uberaba
country: Brazil
state: MG
city: Campo Grande - MS
country: Brazil
state: MS
city: Belem
country: Brazil
state: PA
city: Recife
country: Brazil
state: PE
city: Recife
country: Brazil
state: PE
city: Curitiba
country: Brazil
state: PR
city: Curitiba
country: Brazil
state: PR
city: Niteroi
country: Brazil
state: RJ
city: Nova Iguacu
country: Brazil
state: RJ
city: Rio de Janeiro
country: Brazil
state: RJ
city: Porto Velho
country: Brazil
state: RO
city: Porto Alegre
country: Brazil
state: RS
city: Porto Alegre
country: Brazil
state: RS
city: Rio Grande
country: Brazil
state: RS
city: Sao Jose Do Rio Preto
country: Brazil
state: SC
city: Aracaju
country: Brazil
state: SE
city: Botucatu
country: Brazil
state: SP
city: Campinas
country: Brazil
state: SP
city: Ribeirao Preto
country: Brazil
state: SP
city: Ribeirao Preto
country: Brazil
state: SP
city: Santo Andre
country: Brazil
state: SP
city: Santos
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sorocaba
country: Brazil
state: SP
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: