Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Drotrecogin Alfa (Activated)
Drotrecogin Alfa · 6 trials · 4 indications
Expressed as percentage of participants who died from any cause at Day 28 endpoint.
Mean change in protein C from Study Day 1 to Study Day 7 was tested using an unadjusted two-sample t-test with a two-sided alpha of 0.05. To be included in the primary analysis, Intention-to-Treat (ITT) patients must have at least 1 protein C value available at 24 hours or earlier and at least 1 protein C value at a post-24-hour timepoint.
Number of patients with major bleeding events, defined as: Reduction in hemoglobin of 2 to 5 grams per deciliter (g/dL) within 24 hours; Transfusion of 2 to 4 units of packed red blood cells within 24 hours; Hematoma requiring prolonged hospitalization or surgical intervention; Intracranial or retroperitoneal hemorrhage.
| Arm | Type | Description |
|---|---|---|
| Drotrecogin alfa (activated) | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| 1 | EXPERIMENTAL | 24 microgram/kg/hr for 96 hours (+ or - 1 hour) |
| 2 | PLACEBO_COMPARATOR | 0.9% sodium chloride |
| Standard therapy | EXPERIMENTAL | 24 microgram/kilogram/hour (mcg/kg/hr) for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours |
| Alternative therapy:moderate protein C deficiency | EXPERIMENTAL | 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 48 to 144 hours (original protocol) or an additional 72 to 144 hours (amended protocol) |
| Alternative therapy:severe protein C deficiency | EXPERIMENTAL | 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for 48 to 144 hours (original protocol) or an additional 72 to 144 hours (amended protocol) |
| 3 | EXPERIMENTAL | - |
| 4 | EXPERIMENTAL | - |
| 5 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Drotrecogin alfa (activated) | DRUG | 24 microgram/kilogram/hour, intravenous, 96 hours (hr) |
| Placebo | DRUG | 0.9% sodium chloride, intravenous, 96 hours |
| Enoxaparin | DRUG | 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target International Normalized Ratio (INR) is reached, minimum of 5 days |
Inclusion Criteria: * Must be 18 years or older * Must have evidence of infection * Must have systemic inflammatory response syndrome (SIRS) * Must have vasopressor-dependent septic shock Exclusion Criteria: * Have received vasopressor therapy (at any dose) for greater than 24 hours prior to the ...
Top 3 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
| ImmunityBio Inc | IBRX | 2 | PHASE2 | Nogapendekin alfa inbakicept |
| Bayer | BAYRY | 2 | PHASE1 | BAY 3389934 |
Drotrecogin Alfa was studied for the treatment of sepsis, severe sepsis, and submassive pulmonary embolism. Its clinical program included a Phase 3 trial in adult patients with septic shock and a Phase 3 trial in adult patients with severe sepsis at a low risk of death, along with Phase 2 studies in severe sepsis and submassive pulmonary embolism.
Drotrecogin Alfa targets coagulation factors F5 and F8. It acts as an inhibitor of these targets. This mechanism was the basis for its investigation in sepsis and severe sepsis, conditions in which coagulation and inflammatory pathways are dysregulated.
Drotrecogin Alfa was developed by Eli Lilly and Company, which trades under the ticker LLY. The company sponsored the clinical trial program evaluating the agent in sepsis, severe sepsis, and submassive pulmonary embolism.
Drotrecogin Alfa reached Phase 3 clinical development. Four trials are recorded, all completed, with no active trials. The program included two Phase 3 studies and two Phase 2 studies, and the drug is not described as approved.
Drotrecogin Alfa was evaluated in four completed trials: NCT00604214, a Phase 3 study in adult septic shock; NCT00568737, a Phase 3 study in severe sepsis at low risk of death; NCT00386425, a Phase 2 study of protein C levels in severe sepsis; and NCT00191724, a Phase 2 study in submassive pulmonary embolism.
Yes. Drotrecogin Alfa is also known as Drotrecogin Alfa (Activated) and Drotrecogin alfa (activated). These names refer to the same agent developed by Eli Lilly and Company.