A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Effects of EDP-938 in Hematopoietic Cell Transplant Recipients With Acute Respiratory Syncytial Virus Infection of the Upper Respiratory Tract

Enanta Pharmaceuticals, Inc.0 个研究点入组 200 人开始时间: 2021年7月13日最近更新: 2024年2月19日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Enanta Pharmaceuticals, Inc.
入组人数: 200

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

An ICF signed and dated by the subject
Male or female individuals aged between 16 and 75 years, inclusive
Received an autologous HCT (within 6 months of signing ICF) or an
allogeneic HCT (any time) using any conditioning regimen
Absolute lymphocyte count (ALC) <500 cells/ µL in allogeneic HCT
recipients. Absolute lymphocyte count (ALC) <300 cells/ µL in
autologous HCT recipients.
Laboratory confirmed RSV diagnosis from a respiratory sample within
3 days before signing the ICF. The RSV diagnosis can be determined by
any validated laboratory method.
New onset of at least one of the following respiratory symptoms
within 3 days before signing the ICF: nasopharyngeal discharge,
nasopharyngeal congestion, sneezing, sinus congestion, sore throat,
hoarseness, earache, cough, shortness of breath, respiratory wheeze, or
worsening of one of these symptoms if present chronically (associated
with a previously existing diagnosis [eg, chronic rhinorrhea, chronic lung
disease]) in the 3 days before signing the ICF or at Screening.
No evidence of new abnormalities consistent with LRTI on chest
imaging (chest x-ray and/or computed tomography) performed in the 2
days before signing the ICF. If there is no chest imaging available in the
2 days before signing the ICF, a chest imaging (chest x-ray and/or
computed tomography) must be obtained at the Screening visit.
Oxygen saturation =95% on room air.
A body mass index (BMI) =18 kg/m2 and =40 kg/m2 and a body
weight of =50 kg.
Negative urine pregnancy test for women of childbearing potential as
defined in inclusion criterion #11.
A woman of childbearing potential who is sexually active with a male
must agree to use two effective methods of contraception from the date
of Screening until 30 days after her last dose of study drug. Effective
methods of contraception are defined as follows:
A condom for the male partner and at least one of the following for the
female subject:
a. Intrauterine device
b. Oral, injectable, implantable, transdermal, or intravaginal hormonal
contraceptive
(Note: hormonal contraception must be associated with the inhibition of
ovulation)
The above does not apply to 1) a female subject who has a vasectomized
male partner provided that partner is the sole sexual partner of the
subject and the vasectomized partner has received medical assessment
of surgical success or 2) a female subject who is of nonchildbearing
potential (ie, physiologically incapable of becoming pregnant) as defined
below:
a. Has had a complete hysterectomy =3 months before Screening,
b. Has had a bilateral oophorectomy (ovariectomy),
c. Has had a bilateral tubal ligation or fallopian tube inserts, or
d. Is postmenopausal (a total cessation of menses for at least 2 years;
subjects with a cessation of menses between 1 to 2 years and a folliclestimulating hormone [FSH] level of >35 mIU/mL will also be considered
to be postmenopausal.)
另有 11 项未显示

排除标准

Admitted to the hospital primarily for a lower respiratory tract disease
of any cause as determined by the Investigator.
Known to be concurrently infected with other respiratory viruses (eg,
severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] or other
coronavirus, influenza, parainfluenza, human rhinovirus, adenovirus,
human metapneumovirus) within 7 days before signing the ICF, as
determined by local testing.
Clinically significant viremia, bacteremia, or fungemia, or bacterial or
fungal pneumonia within 2 weeks before signing the ICF that has not
been adequately treated, as determined by the Investigator.
Pregnant or nursing female subjects.
History of drug and/or alcohol abuse that, in the opinion of the
Investigator, may prevent adherence to protocol activities.
Known positive human immunodeficiency virus (HIV).
Heart disease: any congenital heart disease, congenital long QT
syndrome, or any clinical manifestation resulting in QT interval
prolongation. Chronic heart failure or ischemic heart disease or cardiac
disease occurring as a consequence of antineoplastic treatment and for
which treatment medications have not added or increased in the last 3
months are not exclusionary.
Known malignant tumor that may interfere with the aims of the study
or a subject completing the study.
Prior or planned ileal resection or bariatric surgery. Subjects who
have undergone gastric surgeries that do not affect drug absorption (eg,
gastric band or gastric sleeve procedures) will be allowed to participate
if they are stable for at least 1 year before signing the ICF. Gastrectomy
will be allowed if stable for at least 3 years before signing the ICF.
Estimated glomerular filtration rate by Modification of Diet in Renal
Disease (MDRD) <50 mL/min as measured in the 3 days before signing
the ICF or at Screening.
Alanine aminotransferase >5 × ULN as measured in the 3 days
before signing the ICF or at Screening.
Twelve-lead ECG demonstrating a QT interval corrected for heart rate
according to Fridericia (QTcF) that is > 470 milliseconds or other
clinically relevant abnormalities as judged by the Investigator at
Screening.
Use of or intention to use any medication or supplement known to be
a moderate or strong inducer or inhibitor of the CYP3A4 enzyme (Section
5.8) within 14 days before signing the ICF, with the exception of
prophylactic azole antifungal therapies (e.g., fluconazole, itraconazole,
ketoconazole, isavuconazole, posaconazole, and voriconazole), which
are permitted with EDP-938 dose adjustment (Section 4.2.2)
Use of nonmarketed (according to region) or investigational agents,
vaccines, biological products within 30 days or five half-lives before
signing the ICF, whichever is longer.
Use of any investigational monoclonal anti-RSV antibodies within 4
months or five half-lives of signing the ICF, whichever is longer, or use
of any investigational RSV vaccines after HCT.
Known hypersensitivity or allergy to EDP-938 or placebo or their
excipients.
另有 6 项未显示

研究者

发起方

Enanta Pharmaceuticals, Inc.

标识符

注册编号: EUCTR2020-002213-18-GR
其他研究编号: EDP938-103, 135874, 2020-002213-18-FR

日期

最近更新: 2024年2月19日 (2年前)

监管与共享

是否有结果: 否

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