A double blind, randomized, placebo-controlled study to evaluate the antiviral activity, safety and plasma pharmacokinetics of multiple intravenous doses of TMC353121 in hematopoietic stem cell transplant subjects (autologous and allogeneic) with evidence of upper respiratory tract infection (URTI) caused by the respiratory syncytial virus (RSV)

• Conditions: Respiratory Synctycial Virus (RSV)

• Registration Number: EUCTR2006-003439-53-BE
• Lead Sponsor: Tibotec Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified