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

Respiratory Syncytial Virus Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00232635
• Other study ID #: CP204
• Status: Completed
• Phase: Phase 2
• First received: October 4, 2005
• Last updated: February 11, 2010
• Start date: September 2005
• Est. completion date: July 2006

Study information

• Verified date: February 2010
• Source: Arrow Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: National Health ServiceFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Australia: Department of Health and Ageing Therapeutic Goods AdministrationSpain: Spanish Agency of MedicinesBelgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infection
• Respiratory Syncytial Virus Infections
• Virus Diseases

Intervention

Drug:
• A-60444

Locations

Country	Name	City	State
United Kingdom	Stephen MacKinnon	London

Sponsors (1)

Lead Sponsor	Collaborator
Arrow Therapeutics

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of viral load over time:
Primary	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	Change in viral titre over treatment period
Secondary	Safety, pharmacokinetics (PK)