Respiratory Synctycial Virus (RSV)
Conditions
Interventions
Product Name: TMC353121
Product Code: R391036 or JNJ-27387581-AAA, formulation F002
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: N.A
CAS Number: N.A
Current Sponsor code: TMC353121
Sponsors
Tibotec Pharmaceuticals Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject in post-engraftment status of autologous or allogeneic transplantation, with URTI, with nasopharyngeal washings/aspirates positive for RSV, diagnosed locally. Diagnosis of URTI will be considered when in the absence of LRTI diagnosis, at least 1 of the following symptoms is present: rhinitis with nasal discharge, rhinitis with nasal obstruction, sore throat, laryngitis, pharyngitis, otitis media, sinusitis. Diagnosis of LRTI will be considered when at least 1 of the following symptoms is present: wheezing, dyspnea, increased sputum production, increased respiratory rate, pulmonary infiltration (based on chest X-ray, at the discretion of the investigator), fever (in the presence of at least 1 other LRTI related symptom). 2. Subject between 18 and 65 years, extremes included. 3. Informed Consent Form signed voluntarily. 4. Subject agrees to use a reliable double barrier birth control method for the duration of the study. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subject receiving any drug treatment for RSV, such as but not limited to ribavirin, Synagis, Respigam, Numax. 2. Subject with severe acute or chronic graft versus host reaction (GVHR). 3. History of bleeding disorder within the last 5 years. 4. Subject with pathologically prolonged QTc value at study entry 5. Subject with grade 3 or 4 toxicity, as defined by the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table. At the discretion of the investigator, subjects with confirmed stable grade 3 toxicity and grade 3 hematological toxicity may be included. Because of the presence of hydroxypropyl-beta-cyclodextrin in the TMC353121 formulation, patients with moderate to severe renal impairment should not be enrolled (creatinine clearance < 50 mL/min). 6. Pregnant or breast-feeding woman. 7. Subject with pneumonia or requiring a ventilator to breathe, at entry. 8. Subject participating in another clinical trial with an experimental drug, up to 30 days prior to enrolment in this study. 9. Karnofsky performance status < 70%. 10. Patients receiving treatment with itraconazole
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to estimate the antiviral activity and safety of a 7-day dosing regimen with 0.5 mg/kg/2h/day of TMC353121 in RSV infected post-stem cell transplant subjects having URTI.;Secondary Objective: - To evaluate safety parameters of both local and systemic toxicity. - To evaluate severity of clinical signs of URTI (such as rhinitis with nasal discharge, rhinitis with nasal obstruction, sore throat, laryngitis, pharyngitis, otitis media, sinusitis) and LRTI (wheezing, dyspnea, increased sputum production, increased respiratory rate, pulmonary infiltration, fever) over time. - To evaluate progression of URTI to LRTI: 28-day mortality incidence, morbidity, days of hospitalization, days in ICU, length of O2 therapy, lung function (spirometry) and chest X ray. - To document the plasma concentration profile of multiple intravenous doses of TMC353121 on Days 7 to 9, and to assess the time to reach steady-state plasma levels. - To evaluate the general health condition including cGVHD and Karnofsky performance status.;Primary end point(s): - estimation of the antiviral activity and safety of TMC353121 - measurement of levels of TMC353121 in plasma for evaluation of PK parameters - evaluation of nasopharyngeal washings + aspirates for resitance testing - measurement of RSV viral titer in nasopharyngeal washings + aspirates - immunologic value and change, measured by RSV-IgA - adverse events inquiry, vital signs, 12-lead ECG, lung function testing (spirometry, peak expiratory flow, peripheral O2 saturation), performance status, hematology and coagulation, biochemistry, urinalysis | — |
Countries
Belgium
Outcome results
None listed