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NCT Number: NCT00232635

A Study of the Safety and Efficacy of A-60444 in Adults With Respiratory Syncytial Virus (RSV) Infection Following HSCT

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.

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Key information

Conditions

Respiratory Syncytial Virus Infections Infections Mononegavirales Infections Paramyxoviridae Infections Pneumovirus Infections RNA Virus Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stephen MacKinnon

London, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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] 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.
  • Patients, who in the opinion of their general practitioner or the Investigator, should not participate in the study.

Treatment and study plan

A-60444

Drug

Primary outcomes

  1. Reduction of viral load over time:

  2. 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

  1. Change in viral titre over treatment period

  2. Safety, pharmacokinetics (PK)

Sponsors and collaborators

Lead sponsor

Arrow Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Oct 5, 2005
Registry last updated
Feb 12, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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