Clinical trial NCT00232635: A Study of the Safety and Efficacy of A-60444 in Adults With Respiratory Syncytial Virus (RSV) Infection Following HSCT
Official title: A Double-blind, Randomised, Placebo-controlled Study to Evaluate the Safety and Efficacy of A-60444 in Adults With RSV Infection Following Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Respiratory Syncytial Virus Infections
Keywords: RSV
HSCT
HEMATOPOIETIC STEM CELL TRANSPL
Lead sponsor: Arrow Therapeutics
Sponsor class: INDUSTRY
First posted: 2005-10-05
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objectives

Primary Objectives:

* Pilot Study: A preliminary assessment of the exposure 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 and to assess the safety of oral A-60444 in post-stem cell transplant patients with RSV infection.

Secondary Objectives:

* To study the pharmacokinetics of A-60444 in the presence of concomitant medications such as immunosuppressants and antifungals, in post-stem cell transplant patients with RSV infection.

Sample Size: Six patients will be included in the open, pilot phase of the study and there is an option to include a further 22 patients into the main, placebo-controlled study, depending on the pilot study findings. An independent Data Safety Monitoring Board will assess the findings of the pilot study.

Detailed description: Clinical will be recorded daily. A-60444 PK will be studied pre-dose and at peak dose on the last day (Day 5) of dosing.

Eligibility 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.

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 \[ALT\] more than 5 x upper level of normal \[ULN\], total bilirubin more than 3 x ULN). Biochemistry data collected 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.

Primary outcomes:
measure: Reduction of viral load over time:
measure: 2-log reduction (by quantitative real time reverse transcription polymerase chain reaction [rtRT PCR]) in the RSV load of nasopharyngeal swabs in patients three days after treatment with A-60444, compared to patients treated with placebo
Secondary outcomes:
measure: Change in viral titre over treatment period
measure: Safety, pharmacokinetics (PK)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Stephen MacKinnon
Study officials:
affiliation: Royal Free Hospital NHS Foundation Trust
name: Stephen MacKinnon
role: PRINCIPAL_INVESTIGATOR
References: