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Completed

NCT Number: NCT01705717

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

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.

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine Vajira Hospital; Division of Gastroenterology and Hepatology

Bangkok, 10300, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 12, 2012
Registry last updated
Apr 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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