N/A
Completed N=660
A Retrospective Study to Assess the Impact of the Use of Interferon in Patients With Chronic Hepatitis C (DECISION)
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT01280656 ↗
Enrolled (actual)
660
Serious AEs
3.9%
Results posted
Sep 2016
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response at 12 Weeks After End of Treatment — 0; 7.1; 20.8 percentage of participants — p=0.003
Summary
This retrospective study will assess the sustained virologic response and the safety of two different interferons (pegylated or conventional) in patients with chronic hepatitis C. Data will be collected for 24 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response at 12 Weeks After End of Treatment |
0; 7.1; 20.8 | 0.003 sig |
| SECONDARY Percentage of Participants With Sustained Virologic Response at 24 Weeks After End of Treatment |
62.5; 74.6; 72.3 | 0.693 |
| SECONDARY Number of Participants With Interferon Dose Reduction Rates in Function of the Interferon Type Being Used |
1; 9; 29 | — |
| SECONDARY Percentage of Participants With Early Virologic Response at Week 12 |
14.5; 37.2; 35.0 | 0.573 |
| SECONDARY Percentage of Participants With Sustained Virologic Response Treated at Interferon Application Centers and Treated at Home |
NA; 5.0; 2.9; 0; 8.6; 33.3 | — |
| SECONDARY Percentage of Participants Who Were Treated at Interferon Application Centers and at Home and Discontinued Treatment |
NA; 17.4; 17.5; 5.5; 11.8; 21.9 | 0.982 |
| SECONDARY Mean Percentage Reduction of Hemoglobin in Treatment Responders and Treatment Non-Responders |
NA; 14.4; 15.8; 18.3; 9.8; 12.6 | 0.476 |
| SECONDARY Percentage of Participants With Rapid Virologic Response at Week 4 |
6.5; 21.2; 20.3 | 0.792 |
| SECONDARY Percentage of Participants With Virologic Response at End of Treatment |
25.8; 40.4; 35.3 | 0.202 |
| SECONDARY Percentage of Participants With Virologic Relapse up to Week 72 |
37.5; 22.2; 22.8 | 0.921 |
| SECONDARY Percentage of Participants With Null Response or No Responder at End of Treatment |
74.2; 59.6; 64.7 | 0.202 |
| SECONDARY Percentage of Participants Who Discontinued Treatment Due to Adverse Events |
1.6; 4.5; 4.6 | 0.973 |
| SECONDARY Number of Participants With Any Adverse Events and Any Serious Adverse Events |
57; 285; 264; 2; 15; 9 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/=18 years and <70 years of age
- Diagnosis of hepatitis C
- Assessment of viral load prior to treatment (mandatory for genotype 1 only)
- Liver biopsy
- Co-morbidities data
- Use of interferon (pegylated or conventional) and ribavirin to treat hepatitis C infection genotype 2 and 3 and pegylated interferon plus ribavirin to treat hepatitis C infection genotype 1
- Above mentioned treatment started between 01-Sep-2007 and 31-Aug-2008
Exclusion Criteria
- Co-infection with human immunodeficiency virus
- Co-infection with hepatitis B virus
- Presence of hepatocarcinoma
- Patients submitted to hemodialysis
- Organ transplant patients
Data sourced from ClinicalTrials.gov (NCT01280656). 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.