N/A
Completed N=1,656
PROPHESYS 3: Observational Study on Predictors of Response in Patients With Treatment-naïve Chronic Hepatitis C Initiated on Treatment With Pegasys (Peginterferon Alfa-2a) or Peginterferon-alfa-2b
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT01066819 ↗
Enrolled (actual)
1,656
Serious AEs
9.0%
Results posted
Aug 2016
Primary outcomePrimary: Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population — 30.3; 55.7; 43.4; 31.3 percentage of participants
Summary
This observational study will assess predictors of early on-treatment and sustained virological response in treatment-naïve patients with chronic hepatitis C initiated on treatment with Pegasys (peginterferon alfa-2a) or peginterferon alfa-2b and ribavirin. Data will be collected during the treatment period (24 or 48 weeks) and 12 and 24 weeks after the end of treatment. Target sample size is <2000.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population |
30.3; 55.7; 43.4; 31.3; 100.0; 0.0 | — |
| PRIMARY Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population |
31.5; 57.4; 48.8; 35.7; 100.0; 0.0 | — |
| PRIMARY Percentage of Participants With Modified Sustained Virological Response Over Time by Type of Peginterferon and Genotype in Modified All Treated Population |
30.6; 56.1; 43.4; 31.3; 100.0; 0.0 | 0.0045 sig |
| PRIMARY Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population |
31.9; 57.9; 48.8; 35.7; 100.0; 0.0 | — |
| PRIMARY Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population |
53.8; 62.0; 56.1; 20.0; 100.0; 0.0 | — |
| PRIMARY Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population |
54.1; 62.4; 55.0; 20.0; 100.0; 0.0 | — |
| SECONDARY Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time |
6.5; 25.8; 20.8; 12.5; 0.0; 100.0 | — |
| SECONDARY Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time |
7.4; 28.9; 23.6; 14.3; 0.0; 100.0 | — |
| SECONDARY Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time |
7.6; 28.5; 25.8; 18.8; 50.0; 100.0 | — |
| SECONDARY Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time |
7.8; 32.1; 28.5; 21.4; 50.0; 100.0 | — |
| SECONDARY Percentage of Participants With at Least a 2-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 |
19.9; 53.8; 48.4; 25.0; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With at Least a 2-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 |
21.0; 57.4; 52.0; 28.6; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With at Least a 1-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 |
29.2; 56.1; 50.9; 31.3; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With at Least a 1-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Per-Protocol Population at Week 2, Week 4 and Week 12 |
31.1; 59.5; 53.7; 35.7; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population |
45.9; 63.2; 54.5; 0.0; NA; 0.0 | — |
| SECONDARY Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population |
48.6; 61.8; 51.7; 0.0; NA; 0.0 | — |
| SECONDARY Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 |
130; 184; 114; 5; 1; 1 | — |
| SECONDARY Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 |
109; 165; 100; 5; 1; 1 | — |
| SECONDARY Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment |
24.8; 8.5; 22.2; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment |
26.3; 8.8; 19.0; 16.7; 0.0; 10.7 | 0.0162 sig |
| SECONDARY Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per-Protocol Population at 12 Weeks After End of Treatment |
23.4; 8.1; 21.8; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per-Protocol Population at 24 Weeks After End of Treatment |
24.4; 8.3; 18.1; 16.7; 0.0; 11.5 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >/= 18 years of age
- chronic hepatitis C
- HIV HCV co-infection allowed
- informed consent to data collection
Exclusion Criteria
- co-infection with Hepatitis B Virus (HBV)
- previous treatment with peginterferon and/or ribavirin
Data sourced from ClinicalTrials.gov (NCT01066819). 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.