A double-blind, randomised, placebo controlled study to evaluate the safety and efficacy of A-60444 in adults with RSV infection following stem cell transplantatio
- Conditions
- pper 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: 7.0Level: LLTClassification code 10061603
- Registration Number
- EUCTR2004-003657-99-GB
- Lead Sponsor
- Arrow Therapeutics Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 22
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br><br>Main study: To determine the antiviral effect of oral A-60444 versus placebo in post-stem cell transplant patients with RSV infection;·<br><br>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.<br><br>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). <br><br>
- Secondary Outcome Measures
Name Time Method