NCT02873325

Brief Summary

DESIGN: Disease registry - non-interventional. INDICATION: Patients failing first or subsequent line treatment for adenovirus and / or cytomegalovirus reactivation post allogeneic hematopoietic stem cell transplantation.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2016

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

May 11, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2017

Completed
Last Updated

February 1, 2018

Status Verified

January 1, 2018

Enrollment Period

10 months

First QC Date

October 21, 2015

Last Update Submit

January 30, 2018

Conditions

Infectious Complications Following HSCT

Keywords

ADVCMVHSCT

Outcome Measures

Primary Outcomes (1)

  • ADV and/or CMV reactivations

    assessment of ADV/CMV viral clearance to evaluate the efficacy of salvage therapies for ADV and / or CMV infections post allogeneic HSCT

    12 months

Interventions

antiviral therapies for CMV and/or ADVOTHER

salvage antiviral treatments for ADV and/or CMV

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In this disease registry, data on approximately 120 allo HSCT patients who have received salvage treatment (second or later line) with any antiviral therapy for ADV and/or CMV post allogeneic HSCT will be documented; of these 120, at least 40 patients will have been treated with Cell Medica's immune reconstitution ACT as salvage therapy.

1. Written informed consent 2. Physician requested salvage (defined as refractory to first, requirement for second line or greater) treatment for ADV and / or CMV reactivation post allogeneic HSCT.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Birmigham Children Hospital

Birmingham, United Kingdom

Location

Bristol Royal Hospital For Children

Bristol, United Kingdom

Location

Study Officials

  • Prashant Hiwarkar

    Birmingham Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
12 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2015

First Posted

August 19, 2016

Study Start

May 11, 2016

Primary Completion

February 23, 2017

Study Completion

February 23, 2017

Last Updated

February 1, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will share

Locations

GB(2)