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

October 6, 2016 updated by: Hoffmann-La Roche

Retrospective Study to Evaluate the Impact of Using Interferon (Pegylated or Not) in the Treatment of Patients With Chronic Hepatitis C in Brazil (DECISION)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
660

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • AC
      • Rio Branco, AC, Brazil, 69908-210
    • AM
      • Manaus, AM, Brazil, 69040-000
    • BA
      • Salvador, BA, Brazil, 41110-170
    • ES
      • Vitoria, ES, Brazil, 29043-260
    • GO
      • Goiania, GO, Brazil, 74535170
    • MA
      • Sao Luis, MA, Brazil, 65020560
    • MG
      • Pouso Alegre, MG, Brazil, 37550-000
      • Uberaba, MG, Brazil, 38025-180
    • MS
      • Campo Grande - MS, MS, Brazil, 79034-000
    • PA
      • Belem, PA, Brazil, 66050-380
    • PE
      • Recife, PE, Brazil, 50100-130
      • Recife, PE, Brazil, 50670-420
    • PR
      • Curitiba, PR, Brazil, 80810-040
      • Curitiba, PR, Brazil, 80060-900
    • RJ
      • Niteroi, RJ, Brazil, 24033-900
      • Nova Iguacu, RJ, Brazil, 26030-380
      • Rio de Janeiro, RJ, Brazil, 20270-004
    • RO
      • Porto Velho, RO, Brazil, 78812-329
    • RS
      • Porto Alegre, RS, Brazil, 90035-003
      • Porto Alegre, RS, Brazil, 90610-000
      • Rio Grande, RS, Brazil, 96200-310
    • SC
      • Sao Jose Do Rio Preto, SC, Brazil, 15090-000
    • SE
      • Aracaju, SE, Brazil, 49060-100
    • SP
      • 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, 05403-000
      • Sao Paulo, SP, Brazil, 01246-000
      • Sao Paulo, SP, Brazil, 01323-020
      • Sao Paulo, SP, Brazil, 05403-010
      • Sao Paulo, SP, Brazil, 04040-003
      • Sao Paulo, SP, Brazil, 04039-004
      • Sao Paulo, SP, Brazil, 04040-002
      • Sorocaba, SP, Brazil, 18047-600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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: Ribavirin
Ribavirin according to the standard of care and aligned with the local prescription instructions
Drug: Peginterferon Alfa-2a
Peginterferon alfa-2a 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: Ribavirin
Ribavirin according to the standard of care and aligned with the local prescription instructions
Drug: Peginterferon Alfa-2b
Peginterferon alfa-2b according to the standard of care and aligned with the local prescription instructions

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Sustained Virologic Response at 12 Weeks After End of Treatment
Time Frame: At Week 60
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Sustained Virologic Response at 24 Weeks After End of Treatment
Time Frame: At Week 72
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.
At Week 72
Number of Participants With Interferon Dose Reduction Rates in Function of the Interferon Type Being Used
Time Frame: At Week 24
The number of participants with Interferon dose reduction rates in function of the interferon type being used are reported
At Week 24
Percentage of Participants With Early Virologic Response at Week 12
Time Frame: At Week 12
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.
At Week 12
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)
The percentage of participants with SVR-12 and SVR-24 treated at interferon application centers (IAC) and treated at home are presented.
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
Time Frame: Up to Week 48
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.
Up to Week 48
Mean Percentage Reduction of Hemoglobin in Treatment Responders and Treatment Non-Responders
Time Frame: Up to Week 72
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.
Up to Week 72
Percentage of Participants With Rapid Virologic Response at Week 4
Time Frame: At Week 4
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.
At Week 4
Percentage of Participants With Virologic Response at End of Treatment
Time Frame: At Week 48
Virologic response at EOT was defined as undetectable HCV-RNA at EOT (regardless in which week treatment was concluded). EOT = Week 48.
At Week 48
Percentage of Participants With Virologic Relapse up to Week 72
Time Frame: Up to Week 72
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.
Up to Week 72
Percentage of Participants With Null Response or No Responder at End of Treatment
Time Frame: At Week 48
Null response or no responders were defined as those participants presenting positive viral load at EOT (regardless of the treatment duration). EOT= Week 48.
At Week 48
Percentage of Participants Who Discontinued Treatment Due to Adverse Events
Time Frame: Up to Week 48
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.
Up to Week 48
Number of Participants With Any Adverse Events and Any Serious Adverse Events
Time Frame: Up to Week 72
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.
Up to Week 72

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 29, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ML22995

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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