A multi-center, randomized, double-blinded, placebo-controlled, multiple dose study to assess the efficacy of intravenously administered RSV604 in immunocompromised adults with evidence of RSV infectio

Phase 1

• Conditions: Respiratory Syncytial Virus (RSV) infection; MedDRA version: 8.1Level: LLTClassification code 10061603Term: Respiratory syncytial virus infection

• Registration Number: EUCTR2006-006410-15-GB
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-01-22
• Study Completion: 2007-03-14
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

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

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.

Study & Design

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