This study has been terminated.
(Portfolio prioritization due to slow enrollment)
any chance BCRX will participate in this:
The Government intends to have a full & open competition for this requirement in the form of a BAA. This synopsis is not a BAA; a BAA is anticipated on March 28, 2011. The Government expects to make 1 or more awards, subject to the availability of funds, on or about September 17, 2011. "
I see that but most often than not they say: "This study is not yet open for participant recruitment"
Any how we know that HHS is behind the study and this is good new.
Any body care to explain the study being active yet no study locations were given. Normally with a new study it says either recruiting or not recruiting yet.
"Results: 43 adults have been enrolled (target = 150 adults; 50 pediatrics); all with influenza A/H1N1. 17 required mechanical ventilation, 3 ECMO, and 5 renal replacement therapy during treatment. 79% had ³1 underlying chronic medical condition (35% respiratory, 25% immunosuppressive illness).
PK data are available for 39 subjects, with median (range) age at baseline = 46 yr (20‑78), body weight = 74 kg (43‑126), CLcr = 81 mL/min (13‑186). Vz (~23L) was independent of CLcr, as was Cmax from the initial 600mg dose. Consistent with Phase I experience, CL approximated CLcr; AUC and T½ increased accordingly with decreasing CLcr. Dosage adjustment for CLcr led to similar maintenance AUCs.
Grade ³3 adverse events (AEs) were reported in 13 subjects and serious AEs (SAE) in 9 (drug related or possibly related in 7 and 5 subjects, respectively). 4 of the SAEs were fatalities; none considered related to ZAN. ZAN Cmax and AUC were similar in subjects with drug-related AEs/SAEs relative to other patients with comparable CLcr"
"China is no exception, imposed in conformity with WHO of the recommendations, including multiple reserve Tamiflu, Relenza and Rapiacta (Peramivir) and other influenza antiviral agents, also use the object reference in accordance with recommendations and the Department of States Advisory Committee on infectious diseases - influenza prevention group views provide public funds during the pandemic antiviral agent using the object, and usually the "flu antiviral agent configuration and management planning principles", administered by the hospital contract. 如去(98)年H1N1新型流感大流行期間，基於疫情防治之醫療考量，透過健保體系以政府預算支應類流感病患快篩試劑及克流感，以使病患能即時獲得藥物治療，減少病毒擴散及重症之發生。 Such as to (98) years during an influenza pandemic H1N1 novel, based on the epidemic prevention and control of the medical considerations, the government budget through the health care system to cope quickly screen patients for influenza and Tamiflu reagents, so that patients can receive immediate medical treatment, reduce the virus proliferation and severe occurrence. 之後因新流感疫情結束，自99年4月1日起，非原定之公費藥劑使用對象，其快篩試劑及克流感藥劑費用，因非屬全民健保給付項目，則回歸由民眾自費。 After the end result of the new influenza pandemic, since 99 April 1, the non-scheduled pharmaceutical use object of public funds, the rapid screening of pharmaceutical agents and the cost of Tamiflu, is a national health insurance due to non-payment item, then return to the public at their own expense. "