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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
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Hepatitis C, Chronic

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Study Type : Observational
Actual Enrollment : 49 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
cohort



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. Percentage of Participants Who Progressed From CHC to Cirrhosis [ Time Frame: Diagnosis and End of Study, up to 36 months after diagnosis. ]
  4. Percentage of Participants Who Progressed From CHC to Hepatocellular Carcinoma (HCC) [ Time Frame: Diagnosis and End of Study, up to 36 months after diagnosis. ]
  5. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Retrospective survey of medical records of patients with chronic hepatitis C
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

Information from the National Library of Medicine

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


Locations
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Thailand
Faculty of Medicine Vajira Hospital; Division of Gastroenterology and Hepatology
Bangkok, Thailand, 10300
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01705717     History of Changes
Other Study ID Numbers: ML25436
First Posted: October 12, 2012    Key Record Dates
Results First Posted: January 12, 2015
Last Update Posted: April 10, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic