A Retrospective Study to Assess the Impact of the Use of Interferon in Patients With Chronic Hepatitis C (DECISION)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01280656
First received: January 20, 2011
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This retrospective study will assess the sustained virologic response and the sa fety of two different interferons (pegylated or conventional) in patients with c hronic hepatitis C. Data will be collected for 24 weeks.


Condition
Hepatitis C, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Retrospective Study to Access the Impact Caused by the Use of Interferon (Pegylated or Not) for the Treatment of Chronic Hepatitis C Patients in Brazil (DECISION)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Sustained virologic response (SVR) as defined by the percentage of patients with hepatitis C RNA <50IU/ml [ Time Frame: 12 weeks after end of treatment ] [ Designated as safety issue: No ]
  • Treatment discontinuation rate due to adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment discontinuation rate due to adverse events between patients treated with different interferons [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Sustained virologic response (SVR) between patients treated with different interferons [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Interferon dose reduction rates in function of the interferon type being used [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Early virologic response (EVR) rates in function of the interferon type being used [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Comparison of sustained virologic response (SVR) of patients treated in interferon application centers and patients treated at home [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Comparison of treatment discontinuation rates of patients treated at interferon application centers and patients treated at home [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Relationship between sustained virologic response and hemoglobin drop [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 660
Study Start Date: January 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

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 (HIV)
  • Co-infection with hepatitis B virus (HBV)
  • Presence of hepatocarcinoma
  • Patients submitted to hemodialysis
  • Organ transplant patients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01280656

Locations
Brazil
Rio Branco, AC, Brazil, 69908-210
Manaus, AM, Brazil, 69040-000
Salvador, BA, Brazil, 41110-170
Vitoria, ES, Brazil, 29043-260
Goiania, GO, Brazil, 74535170
Sao Luis, MA, Brazil, 65020560
Pouso Alegre, MG, Brazil, 37550-000
Uberaba, MG, Brazil, 38025-180
Campo Grande - MS, MS, Brazil, 79034-000
Belem, PA, Brazil, 66050-380
Recife, PE, Brazil, 50670-420
Recife, PE, Brazil, 50100-130
Curitiba, PR, Brazil, 80810-040
Curitiba, PR, Brazil, 80060-900
Niteroi, RJ, Brazil, 24033-900
Nova Iguacu, RJ, Brazil, 26030-380
Rio de Janeiro, RJ, Brazil, 20270-004
Porto Velho, RO, Brazil, 78812-329
Porto Alegre, RS, Brazil, 90035-003
Porto Alegre, RS, Brazil, 90610-000
Rio Grande, RS, Brazil, 96200-310
Sao Jose Do Rio Preto, SC, Brazil, 15090-000
Aracaju, SE, Brazil, 49060-100
Botucatu, SP, Brazil, 18600-400
Campinas, SP, Brazil, 13060-803
Ribeirao Preto, SP, Brazil, 14085-410
Ribeirao Preto, SP, Brazil, 14049-900
Santo Andre, SP, Brazil, 09060-650
Santos, SP, Brazil, 11015470
Sao Paulo, SP, Brazil, 05403-010
Sao Paulo, SP, Brazil, 01323-020
Sao Paulo, SP, Brazil, 01246-000
Sao Paulo, SP, Brazil, 04039-004
Sao Paulo, SP, Brazil, 05403-000
Sao Paulo, SP, Brazil, 04040-002
Sao Paulo, SP, Brazil, 04040-003
Sorocaba, SP, Brazil, 18047-600
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01280656     History of Changes
Other Study ID Numbers: ML22995
Study First Received: January 20, 2011
Last Updated: July 7, 2014
Health Authority: Brazil: National Health Surveillance Agency (ANVISA)

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 22, 2014