A Retrospective Study to Assess the Impact of the Use of Interferon in Patients With Chronic Hepatitis C (DECISION)
Retrospective Study to Evaluate the Impact of Using Interferon (Pegylated or Not) in the Treatment of Patients With Chronic Hepatitis C in Brazil (DECISION)
1 other identifier
observational
660
1 country
37
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2010
Typical duration for all trials
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 20, 2011
CompletedFirst Posted
Study publicly available on registry
January 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
September 26, 2016
CompletedNovember 29, 2016
October 1, 2016
2.8 years
January 20, 2011
August 2, 2016
October 6, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Sustained Virologic Response at 12 Weeks After End of Treatment
Sustained virological response (SVR) was defined as virological response at 12 weeks after end of treatment (EOT). Virologic response was either defined as having undetectable (that is, no hepatitis C virus Ribonucleic acid \[HCV RNA\] was detected in the participants' plasma samples) or less than 50 international units/milliliter (IU/mL) HCV RNA (that is, the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples). EOT= Week 48. Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy.
At Week 60
Secondary Outcomes (12)
Percentage of Participants With Sustained Virologic Response at 24 Weeks After End of Treatment
At Week 72
Number of Participants With Interferon Dose Reduction Rates in Function of the Interferon Type Being Used
At Week 24
Percentage of Participants With Early Virologic Response at Week 12
At Week 12
Percentage of Participants With Sustained Virologic Response Treated at Interferon Application Centers and Treated at Home
At Week 60 (SVR 12) and Week 72 (SVR 24)
Percentage of Participants Who Were Treated at Interferon Application Centers and at Home and Discontinued Treatment
Up to Week 48
- +7 more secondary outcomes
Study Arms (3)
Conventional Interferon Plus Ribavirin
Eligible participants who will receive conventional interferon plus ribavirin for Chronic Hepatitis C (CHC) according to the standard of care and aligned with the local prescription instructions will be observed during treatment period (48 weeks) and follow up period (24 weeks).
Peginterferon Alfa-2a Plus Ribavirin
Eligible participants who will receive peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions will be observed during treatment period (48 weeks) and follow up period (24 weeks).
Peginterferon Alfa-2b Plus Ribavirin
Eligible participants who will receive peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions will be observed during treatment period (48 weeks) and follow up period (24 weeks).
Interventions
Conventional interferon according to the standard of care and aligned with the local prescription instructions
Peginterferon alfa-2a according to the standard of care and aligned with the local prescription instructions
Peginterferon alfa-2b according to the standard of care and aligned with the local prescription instructions
Ribavirin according to the standard of care and aligned with the local prescription instructions
Eligibility Criteria
Hepatitis C patients that received interferon (pegylated or conventional) during the period stipulated (from 01-Sep-2007 to 31-Aug-2008)
You may qualify if:
- 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
You may not qualify if:
- Co-infection with human immunodeficiency virus
- Co-infection with hepatitis B virus
- Presence of hepatocarcinoma
- Patients submitted to hemodialysis
- Organ transplant patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Unknown Facility
Rio Branco, Acre, 69908-210, Brazil
Unknown Facility
Manaus, Amazonas, 69040-000, Brazil
Unknown Facility
Vitória, Espírito Santo, 29043-260, Brazil
Unknown Facility
Salvador, Estado de Bahia, 41110-170, Brazil
Unknown Facility
Goiânia, Goiás, 74535170, Brazil
Unknown Facility
São Luís, Maranhão, 65020560, Brazil
Unknown Facility
Campo Grande - MS, Mato Grosso do Sul, 79034-000, Brazil
Unknown Facility
Pouso Alegre, Minas Gerais, 37550-000, Brazil
Unknown Facility
Uberaba, Minas Gerais, 38025-180, Brazil
Unknown Facility
Curitiba, Paraná, 80060-900, Brazil
Unknown Facility
Curitiba, Paraná, 80810-040, Brazil
Unknown Facility
Belém, Pará, 66050-380, Brazil
Unknown Facility
Recife, Pernambuco, 50100-130, Brazil
Unknown Facility
Recife, Pernambuco, 50670-420, Brazil
Unknown Facility
Niterói, Rio de Janeiro, 24033-900, Brazil
Unknown Facility
Nova Iguaçu, Rio de Janeiro, 26030-380, Brazil
Unknown Facility
Rio de Janeiro, Rio de Janeiro, 20270-004, Brazil
Unknown Facility
Porto Alegre, Rio Grande do Sul, 90035-003, Brazil
Unknown Facility
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Unknown Facility
Rio Grande, Rio Grande do Sul, 96200-310, Brazil
Unknown Facility
Porto Velho, Rondônia, 78812-329, Brazil
Unknown Facility
Sao Jose Do Rio Preto, Santa Catarina, 15090-000, Brazil
Unknown Facility
Aracaju, Sergipe, 49060-100, Brazil
Unknown Facility
Botucatu, São Paulo, 18600-400, Brazil
Unknown Facility
Campinas, São Paulo, 13060-803, Brazil
Unknown Facility
Ribeirão Preto, São Paulo, 14049-900, Brazil
Unknown Facility
Ribeirão Preto, São Paulo, 14085-410, Brazil
Unknown Facility
Santo André, São Paulo, 09060-650, Brazil
Unknown Facility
Santos, São Paulo, 11015470, Brazil
Unknown Facility
São Paulo, São Paulo, 01246-000, Brazil
Unknown Facility
São Paulo, São Paulo, 01323-020, Brazil
Unknown Facility
São Paulo, São Paulo, 04039-004, Brazil
Unknown Facility
São Paulo, São Paulo, 04040-002, Brazil
Unknown Facility
São Paulo, São Paulo, 04040-003, Brazil
Unknown Facility
São Paulo, São Paulo, 05403-000, Brazil
Unknown Facility
São Paulo, São Paulo, 05403-010, Brazil
Unknown Facility
Sorocaba, São Paulo, 18047-600, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Roche Trial Information Hotline
- Organization
- F. Hoffmann-La Roche AG
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2011
First Posted
January 21, 2011
Study Start
January 1, 2010
Primary Completion
November 1, 2012
Study Completion
June 1, 2013
Last Updated
November 29, 2016
Results First Posted
September 26, 2016
Record last verified: 2016-10