Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00536263 | PegIntron Treatment of Chronic Hepatitis B e Antigen-Positive Patients (P05170/MK-4031-327) | PHASE3 | COMPLETED | 671 | — | — | Sep 1, 2007 | Nov 1, 2009 | Apr 7, 2017 | - | — |
HBeAg Loss was tested by Abbott Microparticle Enzyme Immunoassay (MEIA)
| Arm | Type | Description |
|---|---|---|
| PEG 1.0 mcg/kg weekly (QW) * 24 weeks | ACTIVE_COMPARATOR | PegIntron 1.0 mcg/kg weekly (QW) \* 24 weeks + 24 weeks follow-up |
| PEG 1.5 mcg/kg QW * 24 wks | EXPERIMENTAL | PegIntron 1.5 mcg/kg QW \* 24 wks + 24 wks follow-up |
| PEG 1.5 mcg/kg QW * 48 wks | EXPERIMENTAL | PegIntron 1.5 mcg/kg QW \* 48 wks + 24 wks follow-up |
| Name | Type | Description |
|---|---|---|
| pegylated interferon alpha-2b | DRUG | 1.0 mcg/kg subcutaneously (S.C.) QW for 24 weeks |
Inclusion Criteria: * Adults with chronic hepatitis B: * Serum hepatitis B surface antigen positive for at least 6 months * Serum hepatitis B e antigen positive * Serum negative for hepatitis B surface and e antibodies * Plasma hepatitis B virus deoxyribonucleic acid (DNA) level greater th...