A Retrospective Study of Real World Treatment Outcomes of Patients With Chronic Hepatitis C
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|ClinicalTrials.gov Identifier: NCT01705717|
Recruitment Status : Completed
First Posted : October 12, 2012
Results First Posted : January 12, 2015
Last Update Posted : April 10, 2017
|Condition or disease|
|Hepatitis C, Chronic|
|Study Type :||Observational|
|Actual Enrollment :||49 participants|
|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|
|Actual Study Start Date :||June 1, 2011|
|Actual Primary Completion Date :||May 1, 2012|
|Actual Study Completion Date :||May 1, 2012|
- 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.
- Percentage of Participants Who Were HCV Seronegative at the End of Treatment [ Time Frame: 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 With HCV Relapse (Biochemical or Virological) After Treatment Completion [ Time Frame: 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 Cirrhosis [ Time Frame: Diagnosis and End of Study, up to 36 months after diagnosis. ]
- Percentage of Participants Who Progressed From CHC to Hepatocellular Carcinoma (HCC) [ Time Frame: Diagnosis and End of Study, up to 36 months after diagnosis. ]
- Percentage of Participants Who Died [ Time Frame: Diagnosis and End of Study, up to 36 months after diagnosis ]Any cause of death (including non-liver disease related) was reported.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01705717
|Faculty of Medicine Vajira Hospital; Division of Gastroenterology and Hepatology|
|Bangkok, Thailand, 10300|
|Study Director:||Clinical Trials||Hoffmann-La Roche|