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

NCT01705717 | Completed Results

• 1 other identifier: ML25436
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Percentage of Participants Who Were HCV Seronegative 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

  End of Study, up to 36 months after diagnosis.

• Percentage of Participants Who Progressed From CHC to Cirrhosis

  Diagnosis and End of Study, up to 36 months after diagnosis.

• Percentage of Participants Who Progressed From CHC to Hepatocellular Carcinoma (HCC)

  Diagnosis and End of Study, up to 36 months after diagnosis.

• Percentage of Participants Who Died

  Diagnosis and End of Study, up to 36 months after diagnosis

Study Arms (1)

cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Retrospective survey of medical records of patients with chronic hepatitis C

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Faculty of Medicine Vajira Hospital; Division of Gastroenterology and Hepatology

Bangkok, 10300, Thailand

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffman-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2012
• First Posted: October 12, 2012
• Study Start: June 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: April 10, 2017
• Results First Posted: January 12, 2015

Record last verified: 2017-03

Locations

TH (1)