A study to learn how well the drug EDP 938-102 works and how safe it is in people who have had a bone marrow transplant and are infected with Respiratory Syncytial Virus
- Conditions
- Respiratory syncytial virus (RSV)MedDRA version: 21.1Level: PTClassification code 10061603Term: Respiratory syncytial virus infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2020-002213-18-FR
- Lead Sponsor
- Enanta Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
1. An ICF signed and dated by the subject
2. Male or female individuals aged between 18 and 75 years, inclusive
3. Received an autologous or allogeneic HCT using any conditioning regimen
4. Absolute lymphocyte count (ALC) <500 cells/ µL
5. Laboratory confirmed RSV diagnosis from a respiratory sample obtained not more than 3 days prior signing the ICF. The RSV diagnosis can be determined by any validated laboratory method.
6. 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.
7. No evidence of new abnormalities consistent with LRTI on a chest X-ray performed in the 2 days before signing the ICF. If there is no chest X-ray available in the 2 days before signing the ICF, a chest X-ray must be obtained at the Screening visit.
8. Oxygen saturation =92% on room air.
9. A body mass index (BMI) =18 kg/m2 and =40 kg/m2.
10. Negative urine pregnancy test for women of childbearing potential as defined in inclusion criterion #11.
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. Occlusive cap (diaphragm or cervical/vault caps)
c. Oral, injectable, implantable, transdermal, or intravaginal hormonal contraceptive
The above does not apply to a female subject who has a vasectomized male as the sole partner or 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 follicle-stimulating hormone [FSH] level of >35 mIU/mL will also be considered to be postmenopausal.)
12. A male subject who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of Screening to 90 days after his last dose of study drug. Effective contraception is defined as a condom and at least one of the following for a female partner:
a. Intrauterine device
b. Occlusive cap (diaphragm or cervical/vault caps)
c. Oral, injectable, implantable, transdermal, or intravaginal contraceptive
For a male subject who has had a vasectomy, use of a condom will still be required.
13. Male subjects must agree to refrain from sperm donation from the date of Screening until 90 days after his last dose of study drug.
14. Must be willing and able to adhere to the study assessments, visit schedules, prohibitions, and restrictions, as described in this protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects f
1. Admitted to the hospital primarily for a lower respiratory tract disease of any cause as determined by the Investigator.
2. 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.
3. 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.
4. Pregnant or nursing female subjects.
5. History of drug and/or alcohol abuse that, in the opinion of the Investigator, may prevent adherence to protocol activities.
6. Known positive human immunodeficiency virus (HIV).
7. 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 neoplastic treatment and for which treatment medications have not added or increased in the last 3 months are not exclusionary.
8. Known malignant tumor that may interfere with the aims of the study or a subject completing the study.
9. 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.
10. 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.
11. Alanine transferase >5 × ULN as measured in the 3 days before signing the ICF or at Screening.
12. Twelve-lead ECG demonstrating a QT interval corrected for heart rate according to Fridericia (QTcF) that is >500 milliseconds or other clinically relevant abnormalities as judged by the Investigator at Screening.
13. 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.
14. 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.
15. 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.
16. Known hypersensitivity or allergy to EDP-938 or its excipients.
17. History of or currently experiencing a medical condition or any other finding (including laboratory test results) that, in the opinion of the Investigator, might confound the results of the study, pose an additional risk in administering study drug to the subject, could prevent, limit, or confound the protocol-specified assessments, or deems the subject unsuitable for the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method