N/A
Completed N=4,680
PROPHESYS 1: An Observational Study on Predictors of Response in Treatment-naïve Patients With Chronic Hepatitis C Virus (HCV)Treated With Pegasys (Peginterferon Alfa-2a)
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT01070550 ↗
Enrolled (actual)
4,680
Serious AEs
—
Results posted
Jun 2016
Primary outcomePrimary: Percentage of Participants With Sustained Virological Response by Genotype in Modified All Treated Population — 40.6; 60.4; 55.0; 36.0 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) 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 <5000.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virological Response by Genotype in Modified All Treated Population |
40.6; 60.4; 55.0; 36.0; 57.1; 44.4 | — |
| PRIMARY Percentage of Participants With Sustained Virological Response by Genotype in Per-Protocol Population |
41.7; 62.0; 57.1; 38.8; 66.7; 42.9 | — |
| PRIMARY Percentage of Participants With Modified Sustained Virological Response by Genotype in Modified All-Treated Population |
43.2; 72.4; 60.5; 40.6; 71.4; 44.4 | 0.0126 sig |
| PRIMARY Percentage of Participants With Modified Sustained Virological Response by Genotype in Per-Protocol Population |
44.4; 74.4; 62.3; 44.1; 83.3; 42.9 | — |
| PRIMARY Percentage of Participants With Predictive Values of Virological Response by Week 4 and Week 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population |
71.4; 77.3; 71.1; 68.6; 75.0; 100.0 | — |
| PRIMARY Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population |
72.2; 79.2; 73.2; 67.3; 75.0; 100.0 | — |
| SECONDARY Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time |
4.8; 24.7; 16.2; 8.6; 14.3; 11.1 | — |
| SECONDARY Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time |
4.8; 26.1; 16.8; 8.6; 16.7; 14.3 | — |
| SECONDARY Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time |
6.7; 31.3; 23.0; 13.7; 28.6; 11.1 | — |
| SECONDARY Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time |
6.6; 32.5; 23.6; 13.8; 33.3; 14.3 | — |
| SECONDARY Percentage of Participants With At Least 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12 |
21.5; 49.1; 40.6; 22.3; 42.9; 11.1 | — |
| SECONDARY Percentage of Participants With At Least a 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12 |
21.3; 49.1; 40.5; 22.4; 41.7; 14.3 | — |
| SECONDARY Percentage of Participants With At Least 1-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12 |
33.6; 51.6; 46.0; 35.4; 42.9; 11.1 | — |
| SECONDARY Percentage of Participants With At Least 1 Log Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12 |
33.5; 51.7; 46.1; 35.5; 41.7; 14.3 | — |
| SECONDARY Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12 |
588; 172; 395; 51; 4; 2 | — |
| SECONDARY Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12 |
500; 149; 358; 49; 4; 2 | — |
| 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 |
26.5; 10.2; 19.4; 29.6; 0.0; 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 |
24.4; 10.3; 18.4; 28.6; 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 |
27.1; 12.3; 17.9; 25.3; 9.1; 0.0 | <0.0001 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 |
26.6; 10.8; 16.6; 24.7; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population |
65.7; 89.7; 71.3; 73.3; 50.0; 100.0 | — |
| SECONDARY Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population |
68.3; 91.8; 72.0; 69.2; 50.0; 100.0 | — |
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 Hepatitis B Virus (HBV)
- previous treatment with peginterferon and/or ribavirin
Data sourced from ClinicalTrials.gov (NCT01070550). 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.