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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: October 6, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention
Hepatitis C, Chronic
Drug: Conventional Interferon
Drug: Peginterferon Alfa-2a
Drug: Peginterferon Alfa-2b
Drug: Ribavirin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With Sustained Virologic Response at 12 Weeks After End of Treatment [ Time Frame: At Week 60 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percentage of Participants With Sustained Virologic Response at 24 Weeks After End of Treatment [ Time Frame: At Week 72 ] [ Designated as safety issue: No ]
    SVR was defined as virological response at 24 weeks after EOT, EOT= Week 48. 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 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). 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.

  • Number of Participants With Interferon Dose Reduction Rates in Function of the Interferon Type Being Used [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]
    The number of participants with Interferon dose reduction rates in function of the interferon type being used are reported

  • Percentage of Participants With Early Virologic Response at Week 12 [ Time Frame: At Week 12 ] [ Designated as safety issue: No ]
    An early virologic response (EVR) was defined as a HCV-RNA decrease of at least two logarithmic scales (2 Log) or 100 times the pretreatment value or non-detection at Week 12 of treatment period.

  • Percentage of Participants With Sustained Virologic Response Treated at Interferon Application Centers and Treated at Home [ Time Frame: At Week 60 (SVR 12) and Week 72 (SVR 24) ] [ Designated as safety issue: No ]
    The percentage of participants with SVR-12 and SVR-24 treated at interferon application centers (IAC) and treated at home are presented.

  • Percentage of Participants Who Were Treated at Interferon Application Centers and at Home and Discontinued Treatment [ Time Frame: Up to Week 48 ] [ Designated as safety issue: No ]
    The percentage of participants who were treated at interferon application centers and at home and who discontinued treatment is presented. 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.

  • Mean Percentage Reduction of Hemoglobin in Treatment Responders and Treatment Non-Responders [ Time Frame: Up to Week 72 ] [ Designated as safety issue: No ]
    The average percentage reduction of hemoglobin (Hb) in treatment responders and treatment non-responders between the conventional group, peginterferon alfa-2a plus and peginterferon alfa-2b is presented. Participants with undetectable HCV RNA at specified time points (Weeks 4/12/18/24/48) were considered as treatment responders. Participants with positive viral load (detectable HCV RNA) at end of treatment regardless of the treatment duration were considered as treatment non-responders.

  • Percentage of Participants With Rapid Virologic Response at Week 4 [ Time Frame: At Week 4 ] [ Designated as safety issue: No ]
    Rapid virologic response was defined as qualitative or quantitative HCV-RNA (viral load) undetectable (below the lower limit of detection) at Week 4 of treatment period.

  • Percentage of Participants With Virologic Response at End of Treatment [ Time Frame: At Week 48 ] [ Designated as safety issue: No ]
    Virologic response at EOT was defined as undetectable HCV-RNA at EOT (regardless in which week treatment was concluded). EOT = Week 48.

  • Percentage of Participants With Virologic Relapse up to Week 72 [ Time Frame: Up to Week 72 ] [ Designated as safety issue: No ]
    Virologic relapse was defined as undetectable HCV-RNA at end of treatment and detectable HCV-RNA at the last follow-up assessment available. If the participant was a responder at end of treatment and was not submitted to any viral load assessment during the follow-up period, he was considered a relapser.

  • Percentage of Participants With Null Response or No Responder at End of Treatment [ Time Frame: At Week 48 ] [ Designated as safety issue: No ]
    Null response or no responders were defined as those participants presenting positive viral load at EOT (regardless of the treatment duration). EOT= Week 48.

  • Percentage of Participants Who Discontinued Treatment Due to Adverse Events [ Time Frame: Up to Week 48 ] [ Designated as safety issue: Yes ]
    The percentage of participants with treatment discontinuation rates due to adverse events (AE) between conventional group, peginterferon alfa-2a and peginterferon alfa-2b is presented.

  • Number of Participants With Any Adverse Events and Any Serious Adverse Events [ Time Frame: Up to Week 72 ] [ Designated as safety issue: Yes ]
    An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes.


Enrollment: 660
Study Start Date: January 2010
Study Completion Date: June 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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).
Drug: Conventional Interferon
Conventional interferon according to the standard of care and aligned with the local prescription instructions
Drug: Ribavirin
Ribavirin according to the standard of care and aligned with the local prescription instructions
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).
Drug: Peginterferon Alfa-2a
Peginterferon alfa-2a according to the standard of care and aligned with the local prescription instructions
Drug: Ribavirin
Ribavirin according to the standard of care and aligned with the local prescription instructions
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).
Drug: Peginterferon Alfa-2b
Peginterferon alfa-2b according to the standard of care and aligned with the local prescription instructions
Drug: Ribavirin
Ribavirin according to the standard of care and aligned with the local prescription instructions

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
  • Co-infection with hepatitis B virus
  • 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, 50100-130
Recife, PE, Brazil, 50670-420
Curitiba, PR, Brazil, 80060-900
Curitiba, PR, Brazil, 80810-040
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, 14049-900
Ribeirao Preto, SP, Brazil, 14085-410
Santo Andre, SP, Brazil, 09060-650
Santos, SP, Brazil, 11015470
Sao Paulo, SP, Brazil, 01246-000
Sao Paulo, SP, Brazil, 01323-020
Sao Paulo, SP, Brazil, 04039-004
Sao Paulo, SP, Brazil, 04040-002
Sao Paulo, SP, Brazil, 04040-003
Sao Paulo, SP, Brazil, 05403-000
Sao Paulo, SP, Brazil, 05403-010
Sorocaba, SP, Brazil, 18047-600
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01280656     History of Changes
Other Study ID Numbers: ML22995 
Study First Received: January 20, 2011
Results First Received: August 2, 2016
Last Updated: October 6, 2016
Health Authority: Brazil: National Health Surveillance Agency (ANVISA)

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Ribavirin
Peginterferon alfa-2b
Interferon-alpha
Peginterferon alfa-2a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 09, 2016