NCT00867139已完成1 期
A Pilot, Randomized Study Comparing the Safety, Tolerability and Pharmacokinetics of Combination Therapy (Amantadine, Ribavirin, Oseltamivir) Versus Neuraminidase Inhibitor Monotherapy to Influenza Virus Infected Immunocompromised Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Number of Participants With Adverse Events (AEs), Drug Specific AEs or AEs Resulting in Treatment Interruption
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of triple combination antiviral drug (TCAD) for use in immunocompromised patients with Influenza A infection, and to gain data on the effectiveness of TCAD
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
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •i. Inclusion criteria for randomized arms (both needed):
- •Age ≥7 years, male or female; AND
- •Influenza infection (i.e. upper respiratory tract infection)
- •ii. Inclusion criteria for open-label arm (at least one criteria required):
- •Young age (1-6 years) with any influenza severity, proven or probable influenza A (H1N1)(H274Y); OR
- •History of asthma; OR
- •Older age (≥ 7 years), with no asthma; AND
- •moderate to severe influenza; AND/OR
- •failure in randomized study monotherapy arm iii. Inclusion criteria for all subjects:
- •Able to provide informed consent, or for whom consent may be provided by guardian
- •Immunocompromised, as defined by one of the following:
- •Recent hematopoietic cell transplantation (HCT) (within 2 years, all conditioning regimens, allogeneic, autologous, syngeneic; after 2 years patients with chronic graft-versus-host disease (GVHD) requiring systemic treatment may be included) or solid organ transplantation
- •Patients taking at least 2 immunosuppressants
- •Patients undergoing combination chemotherapy within the past 3 month
- •One or more of the following:
- •Presence of fever at time of screening of ≥ 38.0°C (≥ 100.0°F) taken orally.
- •presence of at least one constitutional symptom (headache, myalgia, malaise, or fatigue) of any severity (mild, moderate, or severe),
- •presence of at least one respiratory symptoms (e.g. cough, or sore throat) of any severity (mild, moderate, or severe),
- •other flu-like symptoms, where the clinician orders a respiratory virus test including influenza A or B
- •Positive test for influenza A (if available)
- •Onset of illness no more than 5 days prior to diagnosis.
- •Females patients of child-bearing age who are capable of conception (i.e. previously have not undergone surgical sterilization) must meet the following criteria:
- •Have been sexually abstinent or have used contraceptive agents (oral contraceptive or other hormonal contraceptives including vaginal rings or transdermal patches, intrauterine device (IUD), or barrier methods including condoms) during the 4 weeks prior to date of screening (3 months prior to enrollment for oral/hormonal contraceptives)
- •Agree to be sexually abstinent or use contraceptive agents (oral contraceptive or other hormonal contraceptives including vaginal rings or transdermal patches, intrauterine device (IUD), or barrier methods including condoms) from the date of screening through 24 weeks after the last dose of study drug
- •Exclusion Criteria(all subjects):
- •Nausea that prevents taking oral medications
- •Use of antiviral influenza medication within 10 days(unless switched from randomized to open-label TCAD). An exception to this exclusion criterion may be made by site investigators for patients admitted after hours who receive one or two initial doses of antiviral influenza medication prior to enrollment.
- •Creatinine clearance (estimated by serum creatinine) less than 30 ml/min
- •Current clinical evidence of a recognized or suspected uncontrolled non-influenza infectious illness with onset prior to screening
- •Known hypersensitivity to amantadine, ribavirin, oseltamivir or zanamivir
- •Women who are pregnant (positive serum or urine pregnancy test), who are attempting to become pregnant, or who are breast-feeding
- •Psychiatric or cognitive illness, or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect patient safety and/or compliance
- •Uncontrolled seizure disorder or history of a seizure activity within 12 months prior to study participation
- •Any significant finding in the patient's medical history or physical exam on Day 1 that, in the opinion of the investigator, would affect patient safety or compliance with the dosing schedule
- •Documented Influenza B viral co-infection
排除标准
- 未提供
研究组 & 干预措施
TCAD-Randomized Arm
Experimental
TCAD (amantadine hydrocholoride, ribavirin and oseltamivir phosphate)
干预措施: TCAD (Drug)
Neuraminidase Monotherapy Arm
Active Comparator
Zanamivir or Oseltamivir
干预措施: Zanamivir or Oseltamivir (Drug)
TCAD Open Label Arm
Other
TCAD for subjects who cannot tolerate or are ineligible to receive zanamivir
干预措施: Open label treatment with TCAD (Other)
结局指标
主要结局
Number of Participants With Adverse Events (AEs), Drug Specific AEs or AEs Resulting in Treatment Interruption
时间窗: 30 days after the final dose of study drug
Abnormal lab data or newly appeared symptoms \& signs were considered as AEs. Examined lab data: Blood cell count (WBC, differential count, Red Blood Cell (RBC), Hemoglobin, Hematocrit, Mean Corpuscular Volume (MCV), Mean Corpuscular Hemoglobin Concentration (MCHC), platelets), Chemistry (Cl, bicarbonate (HCO3), K, Na), Renal function test (BUN, Creatinine, Creatinine clearance), Liver function test (AST, Alanine aminotransferase(ALT), T.Bil, gamma-glutamyltransferase)
次要结局
- Number of Patients Not Shedding Virus at Day 5 +/-1 and Day 10 +/- 1(10 days)
- Number of Participants With Viral Load Decrease as a Function of Time(baseline and 28 days)
- Frequency of Confirmed Pneumonia(58 days)
- Number of Deaths(58 days)
- Duration of Symptoms(from baseline up to 28 days)
- Number of Participants With Intubations(58 days)
- Days on Supplemental Oxygen(58 days)
- Pharmacokinetics (AUC0-last) of TCAD(5 days)
- Number of Participants With Viral Resistance as a Function of Drug Exposure(28 days)
- Duration of Hospitalization(from baseline up to 58 days)
- Number of Participants With ICU Admissions(baseline and up to 58 days)
研究者
Michael Boeckh
Member, Vaccine and Infectious Disease Division
Fred Hutchinson Cancer Center
研究点 (2)
Loading locations...
相似试验
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
2 期
A Randomized Study to Evaluate the Safety, Tolerability and Antiviral Activity of ABT-450, ABT-333 and ABT-072HCVChronic Hepatitis C InfectionHepatitis C Genotype 1Hepatitis CNCT01074008AbbVie (prior sponsor, Abbott)74
撤回
1 期
Evaluation of Safety and Immunogenicity of a Novel Vaccine for Prevention of Covid-19 in Adults Previously ImmunizedCovid19NCT05016934Hospital do Coracao
已完成
3 期
A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) for Treatment of Chronic Hepatitis C Infection in Treatment-experienced AdultsChronic Hepatitis C InfectionNCT01854528AbbVie148
已完成
2 期
A Study of BIBR 1048 in Prevention of Venous Thromboembolism in Patients With TKR Surgery.Arthroplasty, Replacement, KneeVenous ThrombosisNCT00246025Boehringer Ingelheim512