Treatment Outcomes in the Management of Patients With Chronic Hepatitis C: A Case Study of Faculty of Medicine Vajira Hospital, University of Bangkok Metropolis

Hoffmann-La Roche1 site in 1 country49 target enrollmentJune 1, 2011

ConditionsHepatitis C, Chronic

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hepatitis C, Chronic
Sponsor: Hoffmann-La Roche
Enrollment: 49
Locations: 1
Primary Endpoint: Sustained Virological Response (SVR): Percentage of Participants Who Were HCV Seronegative at 6 Months After Completing Therapy
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This retrospective, observational study will assess the real world treatment out comes in the management of patients with chronic hepatitis C. No prospective ass essment or procedure with patients during this study will be conducted. Data wil l be collected from patient medical records of the year 2000-2011.

Registry

clinicaltrials.gov

Start Date

June 1, 2011

End Date

May 1, 2012

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients newly diagnosed with chronic hepatitis C during the year 2000 to 2010
•Availability of data for at least 6 months following the diagnosis date

Exclusion Criteria

•Patients who participated in an investigational clinical trial
•Co-infection with hepatitis A, hepatitis B, hepatitis D, and/or human immunodeficiency virus (HIV)
•Patients with known severe medical conditions that are contraindicated to HCV treatment

Outcomes

Primary Outcomes

Sustained Virological Response (SVR): Percentage of Participants Who Were HCV Seronegative at 6 Months After Completing Therapy

Time Frame: 6 months

SVR was defined a negative result upon polymerase chain reaction (PCR) ribonucleic acid (RNA) diagnostic testing after 6 months of treatment.

Secondary Outcomes

Percentage of Participants Who Progressed From CHC to Cirrhosis(Diagnosis and End of Study, up to 36 months after diagnosis.)
Percentage of Participants With HCV Relapse (Biochemical or Virological) After Treatment Completion(End of Study, up to 36 months after diagnosis.)
Percentage of Participants Who Progressed From CHC to Hepatocellular Carcinoma (HCC)(Diagnosis and End of Study, up to 36 months after diagnosis.)
Percentage of Participants Who Were HCV Seronegative at the End of Treatment(End of Study, up to 36 months after diagnosis.)
Percentage of Participants Who Died(Diagnosis and End of Study, up to 36 months after diagnosis)