Upper respiratory tract infection (as identified by regular surveillance of stem cell transplant patients) or stem cell transplant patients diagnosed as positive for respiratory syncytial virus (RSV). MedDRA version: 7.0 Level: LLT Classification code 10061603
Conditions
Interventions
Product Name: Not assigned
Product Code: A-60444
Pharmaceutical Form: Powder for syrup
Current Sponsor code: A-60444
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number:
Sponsors
Arrow Therapeutics Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with RSV infection who have had a stem cell transplant. 2. Female patients must be of non-childbearing potential or have a negative pregnancy test prior to study start and be deemed not at risk of becoming pregnant. Females of non-childbearing potential are defined as women who have had a hysterectomy, bilateral oophorectomy, tubal ligation or who have been post-menopausal for at least two years, or are considered to be sterile due to recent chemotherapy. 3. Aged between 18 and 65 years. 4. Patients who have given their written informed consent to participate in the study. 5. Patients who are willing and able to comply with the protocol and study procedures. 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. Patients who have received an investigational drug within one month preceding the start of dosing. 2. Patients who have a documented history of allergy to benzodiazepines. 3. Patients with significant hepatic impairment (alanine transaminase (ALT) > 5 x upper level of normal (ULN), total bilirubin > 3 x ULN). Biochemistry data collected less than or equal to four weeks prior to screening is acceptable. 4. Patients, who in the opinion of their general practitioner or the Investigator, should not participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Pilot segment: a preliminary assessment of exposure to and safety of oral A-60444 in post-stem cell transplant patients with RSV infection. Main study: To determine the antiviral effect of oral A-60444 versus placebo in post-stem cell transplant patients with RSV infection;· To assess the safety of oral A-60444 in post-stem cell transplant patients with RSV infection.;Secondary Objective: To study the pharmacokinetics of A-60444 in the presence of concomitant medications such as immunosuppressants and anti-fungals, in post-stem cell transplant patients with RSV infection.;Primary end point(s): Reduction of viral load at 72 hours after initial dose. The primary efficacy measure will be reduction in nasopharyngeal RSV viral load of 2-log as measured by quantitative real time reverse transcription PCR (rtRT-PCR). | — |
Countries
Spain, United Kingdom
Outcome results
None listed