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

NCT ID: NCT02873325

Last Updated: 2018-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-11

Study Completion Date

2017-02-23

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Infectious Complications Following HSCT

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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antiviral therapies for CMV and/or ADV

salvage antiviral treatments for ADV and/or CMV

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cell Medica Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prashant Hiwarkar

Role: PRINCIPAL_INVESTIGATOR

Birmingham Children's Hospital

Locations

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Birmigham Children Hospital

Birmingham, , United Kingdom

Site Status

Bristol Royal Hospital For Children

Bristol, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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CM-2016-01

Identifier Type: -

Identifier Source: org_study_id

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