N/A
Completed N=2,343
PROPHESYS 2: An Observational Study on Predictors of Response in Treatment-naïve Patients With Chronic Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a) or Peginterferon-alfa-2b
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT01066793 ↗
Enrolled (actual)
2,343
Serious AEs
—
Results posted
May 2016
Primary outcomePrimary: Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population — 46.1; 78.0; 68.3; 43.0 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 |
46.1; 78.0; 68.3; 43.0; 55.6; 100.0 | — |
| PRIMARY Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population |
47.2; 79.5; 68.9; 40.2; 57.1; 100.0 | — |
| PRIMARY Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population |
46.5; 78.3; 68.6; 43.0; 66.7; 100.0 | 0.0211 sig |
| PRIMARY Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population |
47.6; 79.5; 69.2; 40.2; 57.1; 100.0 | — |
| PRIMARY Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population |
84.4; 92.2; 77.1; 33.3; NA; NA | — |
| PRIMARY Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population |
82.1; 92.9; 74.2; 0.0; NA; NA | — |
| SECONDARY Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time |
4.1; 21.7; 9.9; 2.6; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time |
4.0; 23.3; 10.4; 2.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time |
4.8; 24.9; 12.7; 3.5; 0.0; 50.0 | — |
| SECONDARY Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time |
4.7; 26.0; 12.7; 2.9; 0.0; 50.0 | — |
| SECONDARY Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 |
14.4; 33.8; 20.1; 5.3; 0.0; 50.0 | — |
| SECONDARY Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 |
14.5; 36.0; 20.4; 4.9; 0.0; 50.0 | — |
| SECONDARY Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12 |
23.7; 37.2; 21.8; 8.8; 0.0; 50.0 | — |
| SECONDARY Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12 |
24.0; 39.9; 22.4; 7.8; 0.0; 50.0 | — |
| SECONDARY Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population |
84.4; 92.2; 77.1; 33.3; NA; NA | — |
| SECONDARY Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population |
82.1; 92.9; 74.2; 0.0; NA; NA | — |
| SECONDARY Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12 |
199; 333; 250; 42; 4; 1 | — |
| SECONDARY Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12 |
186; 298; 213; 39; 2; 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 |
30.0; 10.9; 14.7; 21.4; 0; 0 | — |
| 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 |
29.3; 10.3; 14.3; 25.0; 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 |
28.7; 11.3; 14.2; 29.0; 25.0; 0 | 0.0002 sig |
| 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 |
28.4; 11.5; 13.8; 31.7; 33.3; 0 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >/= 18 years of age
- chronic hepatitis C
- informed consent to data collection
Exclusion Criteria
- co-infection with HIV or HBV
- previous treatment with peginterferon and/or ribavirin
Data sourced from ClinicalTrials.gov (NCT01066793). 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.