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A Retrospective Study of Real World Treatment Outcomes of Patients With Chronic Hepatitis C
trial in Hepatitis C, Chronic in 49 participants. Completed in 1 May 2012.
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 49 |
| Start date | 1 June 2011 |
| Primary completion | 1 May 2012 |
| Estimated completion | 1 May 2012 |
| Sites | 1 location across Thailand |
Hoffmann-La Roche — full company profile →
18 and older, any sex, with Hepatitis C, Chronic. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
SVR was defined a negative result upon polymerase chain reaction (PCR) ribonucleic acid (RNA) diagnostic testing after 6 months of treatment.
| Group | Value | 95% CI |
|---|---|---|
| Non-Cirrhotic CHC Observation Only | 59.5 | |
| HCV - Related Cirrhosis Observation Only | 58.3 |
End-of-treatment response (ETR) was defined as a negative result upon PCR RNA diagnostic testing at the end of treatment.
| Group | Value | 95% CI |
|---|---|---|
| Non-Cirrhotic CHC Observation Only | 91.9 | |
| HCV - Related Cirrhosis Observation Only | 91.6 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Non-Cirrhotic CHC Observation Only | 0 | |
| HCV - Related Cirrhosis Observation Only | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Non-Cirrhotic CHC Observation Only | 0 | |
| HCV - Related Cirrhosis Observation Only | 14.3 |
| Group | Value | 95% CI |
|---|---|---|
| Non-Cirrhotic CHC Observation Only | 0 | |
| HCV - Related Cirrhosis Observation Only | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Non-Cirrhotic CHC Observation Only | 2.7 | |
| HCV - Related Cirrhosis Observation Only | 8.3 |
Any cause of death (including non-liver disease related) was reported.
| Group | Value | 95% CI |
|---|---|---|
| Non-Cirrhotic CHC Observation Only | 2.7 | |
| HCV - Related Cirrhosis Observation Only | 0 |
Time frame: Adverse events (AEs) were recorded from the begininng of treatment through the end of the study, approximately 36 months. This was a retrospective analysis study; safety reporting was generated spontaneously by physician discretion.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | All Participants |
|---|---|---|
| Anemia | Blood and lymphatic system disorders | — |
| Leucopenia | Blood and lymphatic system disorders | — |
| Intracranial hemorrhage | Vascular disorders | — |
| Renal impairment | Renal and urinary disorders | — |
| Severe anemia | Blood and lymphatic system disorders | — |
Data from ClinicalTrials.gov NCT01705717 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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