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

February 11, 2010 updated by: Arrow Therapeutics

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arrow Therapeutics

Investigators

  • Principal Investigator: Stephen MacKinnon, Royal Free Hospital NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

October 4, 2005

First Submitted That Met QC Criteria

October 4, 2005

First Posted (Estimate)

October 5, 2005

Study Record Updates

Last Update Posted (Estimate)

February 12, 2010

Last Update Submitted That Met QC Criteria

February 11, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP204

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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