N/A
Completed N=49
A Retrospective Study of Real World Treatment Outcomes of Patients With Chronic Hepatitis C
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT01705717 ↗
Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcomePrimary: Sustained Virological Response (SVR): Percentage of Participants Who Were HCV Seronegative at 6 Months After Completing Therapy — 59.5; 58.3 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sustained Virological Response (SVR): Percentage of Participants Who Were HCV Seronegative at 6 Months After Completing Therapy |
59.5; 58.3 | — |
| SECONDARY Percentage of Participants Who Were HCV Seronegative at the End of Treatment |
91.9; 91.6 | — |
| SECONDARY Percentage of Participants With HCV Relapse (Biochemical or Virological) After Treatment Completion |
0; 0; 0; 14.3 | — |
| SECONDARY Percentage of Participants Who Progressed From CHC to Cirrhosis |
0; 0 | 0.034 sig |
| SECONDARY Percentage of Participants Who Progressed From CHC to Hepatocellular Carcinoma (HCC) |
2.7; 8.3 | 0.007 sig |
| SECONDARY Percentage of Participants Who Died |
2.7; 0 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01705717). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.