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

NCT00232635 | Completed Phase 2 DMC

• 1 other identifier: CP204
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Syncytial Virus Infections

Keywords

RSV; HSCT; HEMATOPOIETIC STEM CELL TRANSPL

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in viral titre over treatment period

• Safety, pharmacokinetics (PK)

Interventions

A-60444 DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arrow Therapeutics: lead

Study Sites (1)

Stephen MacKinnon

London, London, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Stephen MacKinnon

  Royal Free Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 4, 2005
• First Posted: October 5, 2005
• Study Start: September 1, 2005
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: February 12, 2010

Record last verified: 2010-02

Locations

GB (1)