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

Hepatitis C, Chronic Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01280656
• Other study ID #: ML22995
• Status: Completed
• Phase: N/A
• First received: January 20, 2011
• Last updated: October 1, 2015
• Start date: January 2010
• Est. completion date: April 2012

Study information

• Verified date: October 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency (ANVISA)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 660
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained virologic response (SVR) as defined by the percentage of patients with hepatitis C RNA <50IU/ml		12 weeks after end of treatment	No
Primary	Treatment discontinuation rate due to adverse events		24 weeks	No
Secondary	Treatment discontinuation rate due to adverse events between patients treated with different interferons		24 weeks	No
Secondary	Sustained virologic response (SVR) between patients treated with different interferons		24 weeks	No
Secondary	Interferon dose reduction rates in function of the interferon type being used		24 weeks	No
Secondary	Early virologic response (EVR) rates in function of the interferon type being used		24 weeks	No
Secondary	Comparison of sustained virologic response (SVR) of patients treated in interferon application centers and patients treated at home		24 weeks	No
Secondary	Comparison of treatment discontinuation rates of patients treated at interferon application centers and patients treated at home		24 weeks	No
Secondary	Relationship between sustained virologic response and hemoglobin drop		24 weeks	No
Secondary	Incidence of adverse events		24 weeks	No