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

This study has been completed.
Sponsor:
Information provided by:
Arrow Therapeutics
ClinicalTrials.gov Identifier:
NCT00232635
First received: October 4, 2005
Last updated: February 11, 2010
Last verified: February 2010
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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)

Enrollment: 27
Study Start Date: September 2005
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Arrow Therapeutics
ClinicalTrials.gov Identifier: NCT00232635     History of Changes
Other Study ID Numbers: CP204
Study First Received: October 4, 2005
Last Updated: February 11, 2010
Health Authority: United States: Food and Drug Administration
United Kingdom: National Health Service
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Australia: Department of Health and Ageing Therapeutic Goods Administration
Spain: Spanish Agency of Medicines
Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by Arrow Therapeutics:
RSV
HSCT
HEMATOPOIETIC STEM CELL TRANSPL

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

ClinicalTrials.gov processed this record on September 22, 2014