A Study of the Safety and Efficacy of A-60444 in Adults W... | NCT00232635

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

NCT00232635

Sponsor

Arrow Therapeutics

Status

Completed

Last Update Posted

Feb 12, 2010Estimated

Enrollment

27Actual

Phase

Phase 2

Conditions

Respiratory Syncytial Virus Infections

Interventions

A-60444

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Jul 2006Actual

Completion Date

Jul 2006Actual

First Submitted Date

Oct 4, 2005

First Submission Date that Met QC Criteria

Oct 4, 2005

First Posted Date

Oct 5, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 11, 2010

Last Update Posted Date

Feb 12, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Name	Type	Description	Arm Group Labels	Other Names
A-60444	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Change in viral titre over treatment period
Safety, pharmacokinetics (PK)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Stephen MacKinnon	Royal Free Hospital NHS Foundation Trust	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Stephen MacKinnon		London	London		United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D018357	Respiratory Syncytial Virus Infections

Ancestor Terms

ID	Term
D018186	Pneumovirus Infections
D018184	Paramyxoviridae Infections
D018701	Mononegavirales Infections
D012327	RNA Virus Infections

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Browse Branches

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