A Retrospective Study of Real World Treatment Outcomes of Patients With Chronic Hepatitis C

Completed

• Conditions: Hepatitis C, Chronic

• Registration Number: NCT01705717
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-01
• Primary Completion: 2012-05-01
• Study Completion: 2012-05-01
• Study First Submitted: 2012-10-10
• Study First Submitted QC: 2012-10-10
• Study First Posted: 2012-10-12
• Results First Submitted: 2015-01-05
• Results First Submitted QC: 2015-01-05
• Results First Posted: 2015-01-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-10
• Last Update Posted: 2017-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sustained Virological Response (SVR): Percentage of Participants Who Were HCV Seronegative at 6 Months After Completing Therapy	6 months	SVR was defined a negative result upon polymerase chain reaction (PCR) ribonucleic acid (RNA) diagnostic testing after 6 months of treatment.

Secondary Outcome Measures

Name	Time	Method
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.	HCV relapse was determined by PCR RNA diagnostic testing. Virological relapse was defined as subsequent reappearance of serum HCV RNA after completion of therapy in participants who achieved end of treatment virological response (undetectable HCV RNA). Biochemical relapse was defined as subsequent rise in serum alanine aminotransferase (ALT) level after end of treatment with normal ALT.
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.	End-of-treatment response (ETR) was defined as a negative result upon PCR RNA diagnostic testing at the end of treatment.
Percentage of Participants Who Died	Diagnosis and End of Study, up to 36 months after diagnosis	Any cause of death (including non-liver disease related) was reported.

Trial Locations

Locations (1)

Faculty of Medicine Vajira Hospital; Division of Gastroenterology and Hepatology; 🇹🇭 Bangkok, Thailand