Respiratory Syncytial Virus (RSV) infection MedDRA version: 8.1 Level: LLT Classification code 10061603 Term: Respiratory syncytial virus infection
Conditions
Interventions
Product Name: RSV604
Product Code: RSV604
Pharmaceutical Form: Intravenous infusion
CAS Number: 676128-63-5
Current Sponsor code: RSV604
Concentration unit: mg milligram(s)
Concentration type: equal
C
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Evidence of RSV infection in patients who are immunocompromised based on underlying disease, disease treatment or immunosuppressive therapy, excluding HIV patients. This includes patients with evidence of RSV infection who meet any one of the following conditions: • Allogeneic stem cell transplant recipients • Autologous stem cell transplant recipients within one year of transplant • Lung, heart, kidney or heart-lung transplant recipients • Patients receiving chemotherapy or immunocompromised from a hematological malignancy (leukemia and lymphoma) • Solid tumor patients with advanced immunosuppressive regimens, as determined by the investigator (e.g. renal cell carcinoma, metastatic malignant melanoma) 2. Age 18 years or greater with no evidence of moderate to severe CNS depressed function. 3. Weight must be between 40 – 140 kg, inclusive. 4. Female subjects of child bearing potential must be using a double-barrier local contraception, i.e. intra-uterine device plus condom, or spermicidal gel plus condom until end of study. OR: Postmenopausal women must have no regular menstrual bleeding for at least 1 years prior to inclusion. OR: Female subjects must have been surgically sterilized at least 6 months prior to screening. Surgical sterilization procedures must be supported with clinical documentation made available to sponsor and noted in the Relevant Medical History / Current Medical Conditions section of the CRF. 5. Male subjects must be using a double-barrier local contraception, i.e., spermicidal gel plus condom, for the entire duration of the study, up to Study Completion visit,. 6. Able to communicate well with the investigator, to understand and comply with the requirements of the study. Able to understand and sign the written informed consent. 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 for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Participation in experimentally unlicensed therapeutic antiviral investigation within one week prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations. 2. Prior use of ribavirin within 2 weeks. 3. History of active or recent significant hemolysis. 4. Documented history of allergy to benzodiazepines. 5. History of a positive HIV (ELISA and Western blot) test results. If results are older than 6 months, another HIV test must be performed. 6. Significant hepatic impairment (alanine transaminase (ALT) >3x upper level of normal (ULN), total bilirubin >3x ULN). 7. Significant renal impairment (Creatinine clearance less than 65% of normal as calculated by the Cockcroft-Gault method). (Cockcroft and Gault, 1976) 8. Past medical history of clinically significant ECG abnormalities or a family history (grandparents, parents and siblings) of a prolonged QT-interval syndrome. 9. Patients, who in the opinion of the investigator, should not participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the ability of RSV604 to significantly reduce nasopharyngeal viral load during 5 days of intravenous therapy compared with placebo in immunocompromised adult patients with evidence of RSV infection. To determine the safety and tolerability of RSV604 when administered intravenously in immunocompromised adult patients with RSV infection.;Secondary Objective: • To explore for exposure-response relationships between RSV604 plasma levels and viral load reduction. • To assess the duration of RSV shedding in response to RSV604 versus placebo when combined with standard of care supportive therapy. • To evaluate clinical outcome in response to RSV604 therapy. Exploratory objectives • To perform exploratory pharmacogenetic assessments to examine whether individual genetic variation in genes relates to the response to RSV604 versus placebo. • To asses if inflammatory cytokines and chemokines in serum can be used as biomarkers predictive of severity and progression of RSV infection and response to RSV604. • To assess change in FEV1 from Day 1 to Day 5 in response to RSV604 therapy. ;Primary end point(s): Decrease in nasopharyngeal RSV viral load | — |
Countries
United Kingdom
Outcome results
None listed