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

Hepatitis C, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01705717
• Other study ID #: ML25436
• Status: Completed
• Phase: N/A
• First received: October 10, 2012
• Last updated: January 5, 2015
• Start date: June 2011
• Est. completion date: May 2012

Study information

• Verified date: January 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Thailand Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

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

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained Virological Response (SVR): Percentage of Participants Who Were HCV Seronegative at 6 Months After Completing Therapy	SVR was defined a negative result upon polymerase chain reaction (PCR) ribonucleic acid (RNA) diagnostic testing after 6 months of treatment.	6 months	No
Secondary	Percentage of Participants Who Were HCV Seronegative at the End of Treatment	End-of-treatment response (ETR) was defined as a negative result upon PCR RNA diagnostic testing at the end of treatment.	End of Study, up to 36 months after diagnosis.	No
Secondary	Percentage of Participants With HCV Relapse (Biochemical or Virological) After Treatment Completion	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.	End of Study, up to 36 months after diagnosis.	No
Secondary	Percentage of Participants Who Progressed From CHC to Cirrhosis		Diagnosis and End of Study, up to 36 months after diagnosis.	No
Secondary	Percentage of Participants Who Progressed From CHC to Hepatocellular Carcinoma (HCC)		Diagnosis and End of Study, up to 36 months after diagnosis.	No
Secondary	Percentage of Participants Who Died	Any cause of death (including non-liver disease related) was reported.	Diagnosis and End of Study, up to 36 months after diagnosis	No