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

March 10, 2017 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10300
        • Faculty of Medicine Vajira Hospital; Division of Gastroenterology and Hepatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Retrospective survey of medical records of patients with chronic hepatitis C

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
End of Study, up to 36 months after diagnosis.
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.
End of Study, up to 36 months after diagnosis.
Percentage of Participants Who Progressed From CHC to Cirrhosis
Time Frame: Diagnosis and End of Study, up to 36 months after diagnosis.
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.
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.
Diagnosis and End of Study, up to 36 months after diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

October 10, 2012

First Submitted That Met QC Criteria

October 10, 2012

First Posted (Estimate)

October 12, 2012

Study Record Updates

Last Update Posted (Actual)

April 10, 2017

Last Update Submitted That Met QC Criteria

March 10, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML25436

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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