N/A
Completed N=1,842
An Observational Cohort Study in Patients With Chronic Hepatitis B Receiving Pegasys
Hepatitis B, Chronic
Source: ClinicalTrials.gov NCT01011738 ↗
Enrolled (actual)
1,842
Serious AEs
6.2%
Results posted
Apr 2016
Primary outcomePrimary: Percentage of Participants With Hepatitis B Virus Surface Antigen Clearance — 2; 5; 5; 10 Percentage of Participants
Summary
This observational, non-interventional cohort study will evaluate predictors of response in patients with chronic hepatitis B receiving standard of care Pegasys therapy. Efficacy and safety parameters will also be evaluated. Patients included in the study will be followed for the duration of their treatment and for up to 3 years thereafter.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Hepatitis B Virus Surface Antigen Clearance |
2; 5; 5; 10 | — |
| PRIMARY Predictive Values of Early on Treatment Response for Hepatitis B Surface Antigen Clearance 3 Years Post-Treatment- Hepatitis B Virus e Antigen Positive Participants |
4; 11; 99; 98; 2; 4 | 0.0022 sig |
| PRIMARY Predictive Values of Early on Treatment Response for Hepatitis B Surface Antigen Clearance 3 Years Post-Treatment- Hepatitis B Virus e Antigen Negative Participants |
7; 13; 98; 96; 8; 16 | 0.0033 sig |
| SECONDARY Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid to <2,000 International Units Per Milliliter |
39; 70; 54; 89; 24; 33 | — |
| SECONDARY Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion in Hepatitis B Virus e Antigen Positive Participants |
14; 23; 16; 28; 17; 32 | — |
| SECONDARY Percentage of Participants With Hepatitis B Virus e Antigen Loss in Hepatitis B Virus e Antigen Positive Participants |
18; 27; 21; 35; 22; 40 | — |
| SECONDARY Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion and Hepatitis B Virus Deoxyribonucleic Acid <2000IU/mL in Hepatitis B Virus e Antigen Positive Participants |
11; 20; 9; 17; 7; 14 | — |
| SECONDARY Percentage of Participants With Hepatitis B Surface Antigen Seroconversion |
2; 1; 5; 5; 2; 3 | — |
| SECONDARY Quantitative Hepatitis B Surface Antigen |
3.94; 3.45; 0.32; 0.18; 0.57; 0.39 | — |
| SECONDARY Percentage of Participants With Normalization of Alanine Transaminase |
23; 23; 25; 25; 28; 27 | — |
| SECONDARY Alanine Transaminase Ratio Over Time by Hepatitis B Virus e Antigen Status |
2.07; 2.14; 1.92; 1.69; 1.59; 1.42 | — |
| SECONDARY Number of Participants With Chronic Hepatitis B - Associated Clinical Endpoints- Liver Transplantation, Hepatocellular Carcinoma, and Liver Decompensation |
0; 1; 4; 7; 7; 2 | — |
| SECONDARY Number of Participants With Chronic Hepatitis B Associated Clinical Endpoints- Liver Cirrhosis |
59; 82; 11; 4; 3; 3 | — |
| SECONDARY Number of Participants With Serious Adverse Drug Reactions |
18; 22; 0 | — |
| SECONDARY Number of Participants With Non-Serious Adverse Drug Reactions |
585; 599; 28 | — |
| SECONDARY Number of Participants With Adverse Events and Serious Adverse Events |
618; 646; 30; 47; 63; 2 | — |
| SECONDARY Number of Deaths During Observation Period |
3; 9; 0 | — |
Eligibility Criteria
Inclusion Criteria
- adult patient, >/= 18 years of age
- chronic hepatitis B
- treatment with peginterferon alfa-2A
Exclusion Criteria
- coinfection with HAV, HCV and HIV
Data sourced from ClinicalTrials.gov (NCT01011738). 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.