NCT00957996已完成3 期
A Phase 3, Open-Label, Randomized Study of the Antiviral Activity, Safety, and Tolerability of Intravenous Peramivir in Hospitalized Subjects With Confirmed or Suspected Influenza Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 234
- 主要终点
- Change From Baseline in Influenza Virus Titer (48 Hours)
研究概览
简要总结
This is a Phase 3, open-label, randomized study of the antiviral activity, safety, and tolerability of intravenous Peramivir in hospitalized subjects with confirmed or suspected influenza infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and non-pregnant female subjects 6 years of age or older.
- •Able to provide written informed consent, or for whom written consent may be provided by a parent guardian or legally authorized representative, unless consent provided by a parent, guardian or legally authorized representative is not consistent with applicable local or ethical procedures, directives and /or guidelines.
- •Presence of clinical signs and/or symptoms consistent with an acute illness compatible with influenza infection; a measured temperature of ≥ 38.0°C (100.4°F) oral, or ≥ 38.6°C (101.4°F) rectal or tympanic and recent onset of at least one of the following: rhinorrhea or nasal congestion, sore throat or cough. Measured temperature can include fever meeting the above criteria as reported by the subject or their parent, guardian or legally authorized representative in the 24 hours prior to Screening. The requirement for fever is waived for any subject with influenza infection already confirmed by laboratory tests (including Rapid Antigen Tests).
- •Confirmation of influenza A or B infection in the local community by one of the following means:
- •the institution's local laboratory,
- •the local public health system
- •the national public health system
- •a laboratory of a recognized national or multinational influenza surveillance scheme.
- •Severity of illness requiring or anticipated to require in-hospital care.
排除标准
- •Subjects who have been hospitalized for greater than 24 hours (not including time spent in the emergency department).Blood platelet count of < 20 x 109/L.
- •Serum bilirubin > 6 mg/dL at time of Screening evaluation.
- •Serum ALT or AST > 5 X upper limit of normal at time of Screening evaluation.
- •Serum creatinine > 5.0 mg/dL at time of Screening evaluation.
- •Subjects who require peritoneal dialysis or hemofiltration.
- •Altered neurologic status as defined by a Glasgow Coma Score of ≤ 9, unless medically induced.
- •Females who are pregnant (positive urine or serum pregnancy test at Screening evaluation) or breastfeeding.
- •Actively undergoing systemic chemotherapy or radiotherapy treatment for a malignancy. (Subjects who have completed treatment 30 days prior to enrollment are allowed to enroll in the study. Hormone treatment for cancer is also acceptable).
- •Prior hematopoietic stem cell transplantation or solid organ transplant during the previous 4 months.
- •HIV infection with a known CD4 count < 200 cells/ mm3 unless on a stable highly active antiretroviral (HAART) regimen for at least 6 months.
- •Presence of a preexisting chronic infection that is undergoing or requiring medical therapy (eg, tuberculosis). (Subjects with chronic osteomyelitis or hepatitis B or C not requiring treatment are not excluded).
- •Presence of any preexisting illness that, in the opinion of the Investigator, would place the subject at an unreasonably increased risk through participation in this study.
- •Participation as a subject in any study of an experimental treatment for any condition within the 30 days prior to the time of the Screening evaluation.
- •Subjects diagnosed with cystic fibrosis.
- •Subjects with confirmed clinical evidence of acute non-influenzal infection at the time of Screening.
研究组 & 干预措施
Peramivir 300 mg
Experimental
Peramivir 300 mg twice daily
干预措施: Peramivir (Drug)
Peramivir 600 mg
Experimental
Peramivir 600 mg once daily
干预措施: Peramivir (Drug)
结局指标
主要结局
Change From Baseline in Influenza Virus Titer (48 Hours)
时间窗: Baseline and 48 hours
The time-weighted change from baseline in log10 tissue culture infective dose50 (TCID50/mL) was calculated on a by-subject basis through 48 hours using the trapezoidal rule with all available data minus the baseline value. Ninety-five percent confidence intervals about the median time-weighted change from baseline were presented for each treatment group.
次要结局
- Change in Influenza Virus Titer, as Measured by Quantitative RT-PCR (log10 vp/mL)(Baseline, 48, 108, 216 hours)
- Time to Clinical Resolution(28 days)
- Number of Participants With Clinical Resolution(28 days)
- Time to Alleviation of Symptoms(28 days)
- Time to Resolution of Fever(28 days)
- Time to Resumption of Usual Activities(28 days)
- Time to Hospital Discharge(28 days)
- Number of Participants Experiencing Influenza-related Complications(28 days)
- Number of Participants Admitted to ICU After Initiation of Treatment(28 days)
- Duration of Postbaseline ICU Admission (Kaplan-Meier Estimate)(28 days)
- Survival (Kaplan-Meier Estimates)(14 and 28 days)
研究者
相似试验
已完成
3 期
Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Participants With Chronic Genotype 1 or 2 Hepatitis C Virus Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing RegimenHepatitis C Virus InfectionNCT02822794Gilead Sciences117
已完成
4 期
Continuing Lamivudine vs Switching to Entecavir in Patients With Detectable HBV DNAHepatitis B, ChronicNCT00625560Yonsei University72
已完成
3 期
Study of Lopinavir/ Ritonavir and Lamivudine Versus Standard Therapy in Naïve HIV-1 Infected Subjects.HIV InfectionNCT01237444Pedro Cahn417
已完成
3 期
Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Adults With Chronic HCV Infection and Decompensated CirrhosisHepatitis C Virus InfectionNCT02996682Gilead Sciences102
已完成
3 期
Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV InfectionHepatitis C Virus InfectionNCT02472886Gilead Sciences153