A Study of the Safety and Efficacy of A-60444 in Adults With Respiratory Syncytial Virus (RSV) Infection Following Stem Cell Transplantation - Full Text View

Sponsored by:	Arrow Therapeutics
Information provided by:	Arrow Therapeutics
ClinicalTrials.gov Identifier:	NCT00232635

Purpose

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.

Condition	Intervention	Phase
Respiratory Syncytial Virus Infections	Drug: A-60444	Phase II

MedlinePlus related topics: Respiratory Syncytial Virus Infections

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Arrow Therapeutics:

Primary Outcome Measures:

Reduction of viral load over time:
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 Outcome Measures:

Change in viral titre over treatment period
Safety, pharmacokinetics (PK)

Estimated Enrollment:	28
Study Start Date:	September 2005
Study Completion Date:	July 2006

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients diagnosed with RSV infection who have had a stem cell transplant.
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.
Aged between 18 and 65 years.
Patients who have given their written informed consent to participate in the study.
Patients who are willing and able to comply with the protocol and study procedures.

Exclusion Criteria:

Patients who have received an investigational drug within one month preceding the start of dosing.
Patients who have a documented history of allergy to benzodiazepines.
Patients with significant hepatic impairment (alanine transaminase [ALT] > 5 x upper level of normal [ULN], total bilirubin > 3 x ULN). Biochemistry data collected  four weeks prior to screening is acceptable.
Patients, who in the opinion of their general practitioner or the Investigator, should not participate in the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232635

Locations

United Kingdom
Stephen MacKinnon
London, United Kingdom

Sponsors and Collaborators

Arrow Therapeutics

Investigators

Principal Investigator:

Stephen MacKinnon

Royal Free Hospital

More Information

Study ID Numbers:	CP204
Study First Received:	October 4, 2005
Last Updated:	August 29, 2007
ClinicalTrials.gov Identifier:	NCT00232635
Health Authority:	United States: Food and Drug Administration; United Kingdom: National Health Service; France: Afssaps - French Health Products Safety Agency; Australia: Department of Health and Ageing Therapeutic Goods Administration; Spain: Spanish Agency of Medicines; Belgium: Directorate general for the protection of Public health: Medicines

Keywords provided by Arrow Therapeutics:

RSV
HSCT
HEMATOPOIETIC STEM CELL TRANSPL

Study placed in the following topic categories:

Virus Diseases
Paramyxoviridae Infections
Respiratory Syncytial Virus Infections

Additional relevant MeSH terms:

Communicable Diseases
RNA Virus Infections
Pneumovirus Infections
Infection
Mononegavirales Infections

ClinicalTrials.gov processed this record on January 16, 2009