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TerminatedNCT02873325EPROSUpdated Feb 1, 2018

Registry on Salvage Antiviral Treatment for Patients Experiencing ADV and / or CMV Reactivation Post Allogeneic HSCT

An observational study in Infectious Complications Following HSCT, sponsored by Cell Medica Ltd. Terminated at 2 sites in United Kingdom. Per ClinicalTrials.gov, last updated 2018-02-01.

Sponsored by Cell Medica Ltd · Observational

Why this study was terminated
Lack of study recruitment
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
1
Sex
All
01

Study 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.

Read the detailed description

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. The patients will be consented prospectively or retrospectively for collection of data. Data will be collected at baseline, 6 months and 1 year after commencement of salvage treatment. Retrospective data collection (for patients who underwent HSCT in 2010 or later) is permitted.

02

Conditions studied

  • Infectious Complications Following HSCT

Keywords

  • ADV
  • CMV
  • HSCT
03

In context

Communicable Diseases

4,452 studies on the registry are indexed under Communicable Diseases; 521 are open to participants now.

This study's enrollment of 1 is below the median of 244 across 1,499 observational studies indexed under Communicable Diseases.

Browse Communicable Diseases studies →

Lead sponsor

Cell Medica Ltd is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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.

Eligibility criteria

  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.
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
1 participant (actual)
Target follow-up
12 Months
Patient registry
Yes

Interventions

  • Otherantiviral therapies for CMV and/or ADV

    salvage antiviral treatments for ADV and/or CMV

06

What researchers measure

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

    Time frame: 12 months

07

Study locations

2 sites
  • Birmigham Children Hospital
    Birmingham, United Kingdom
  • Bristol Royal Hospital For Children
    Bristol, United Kingdom
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02873325
Lead sponsor
Cell Medica Ltd
Responsible party
Sponsor
First posted
Aug 19, 2016
Start date
May 11, 2016
Primary completion
Feb 23, 2017
Completion
Feb 23, 2017
Last update
Feb 1, 2018

Study contacts

Prashant Hiwarkar
principal investigator · Birmingham Children's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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