Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Recombinant Factor VIIa · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| rFVIIa | EXPERIMENTAL | intravenous administration of rFVIIa (Novoseven; 90 micrograms/kg, IV push, given at start of first surgical incision and again at 1 hr after start of surgery) |
| Control | PLACEBO_COMPARATOR | intravenous administration of placebo (sterile water, IV push, given at first surgical incision and again at 1 hr after start of surgery) |
| Name | Type | Description |
|---|---|---|
| Recombinant Factor VIIa | DRUG | intravenous infusion of Factor VIIa |
| Placebo | DRUG | intravenous infusion of placebo (sterile water) |
Inclusion Criteria: * Male or female * Burn wounds * 18-65 years of age * Scheduled excision of burn wound of at least 20 percent TBSA Exclusion Criteria: * Age greater than 65 years * History of blood coagulation disorders * Taking anti-coagulation medication * Contraindication for heparin thera...
Recombinant Factor VIIa is being studied for use in burns, specifically to reduce peri-operative blood loss in patients undergoing major burn surgery. It is an investigational therapy in Phase 3 clinical development, and it is not yet approved for this indication.
Recombinant Factor VIIa targets the coagulation pathway by acting as a clotting factor. It is designed to promote hemostasis and reduce bleeding. In the context of burns, it is being evaluated for its ability to decrease blood loss during surgical procedures.
Recombinant Factor VIIa is being developed by United Therapeutics Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol UTHR. The company is conducting clinical research to evaluate the drug's safety and efficacy in burn patients.
Recombinant Factor VIIa is in Phase 3 clinical development for the treatment of burns. It is an investigational drug, meaning it has not yet received regulatory approval and is still undergoing clinical trials to assess its effectiveness and safety.
Recombinant Factor VIIa has one completed Phase 3 clinical trial, identified by the National Clinical Trial number NCT00243243. This trial, titled 'Effect of rFVIIa on Peri-operative Blood Loss in Patients Undergoing Major Burn,' enrolled 20 participants in the United States and was a randomized, double-blind, placebo-controlled study.
Yes, Recombinant Factor VIIa is also known as rFVIIa. The clinical trial NCT00243243 uses the abbreviation rFVIIa in its title, confirming that these names refer to the same investigational drug being studied for reducing peri-operative blood loss in major burn surgery.