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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00232635
Recruitment Status : Completed
First Posted : October 5, 2005
Last Update Posted : February 12, 2010
Information provided by:
Arrow Therapeutics

Brief Summary:


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 or disease Intervention/treatment Phase
Respiratory Syncytial Virus Infections Drug: A-60444 Phase 2

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  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2005
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  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 Outcome Measures :
  1. Change in viral titre over treatment period
  2. Safety, pharmacokinetics (PK)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00232635

United Kingdom
Stephen MacKinnon
London, United Kingdom
Sponsors and Collaborators
Arrow Therapeutics
Principal Investigator: Stephen MacKinnon Royal Free Hospital NHS Foundation Trust

Responsible Party: Arrow Therapeutics Identifier: NCT00232635     History of Changes
Other Study ID Numbers: CP204
First Posted: October 5, 2005    Key Record Dates
Last Update Posted: February 12, 2010
Last Verified: February 2010

Keywords provided by Arrow Therapeutics:

Additional relevant MeSH terms:
Communicable Diseases
Virus Diseases
Respiratory Syncytial Virus Infections
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections