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NCT03044353 · ClinicalTrials.gov registry record · Phase 2
Multiple Treatment Session Study to Assess GSK2398852 Administered Following and Along With GSK2315698
A Phase 2 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT03044353 is a Phase 2 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 7 participants.
The verdict
NCT03044353, a Phase 2 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
The study is intended to evaluate whether monthly repeated courses of administration of GSK2315698 followed by GSK2398852 is associated with a reduction in cardiac amyloid load in patients with cardiac amyloidosis, monitored by cardiac magnetic resonance imaging (CMR) and echocardiography (ECHO), and whether this is associated with an improvement in cardiac function. Cohort 1 is transthyretin cardiomyopathy (ATTR-CM) , cohort 2 is patients with immunoglobulin light chain (AL) systemic amyloidosis at greater than 6 months post chemotherapy, cohort 3 newly diagnosed AL systemic amyloidosis undergoing chemotherapy. Primary objectives for the study are assessment of reduction in cardiac amyloid load after repeated administrations of Anti-SAP treatment as evaluated by CMR in all study groups and assessment of safety \& tolerability of repeated administration of Anti-SAP treatment, including compatibility with chemotherapy treatment in patients with AL systemic amyloidosis. This is an open label, non-randomised, three-group, monthly repeat Anti-SAP treatment study in systemic amyloidosis patients with cardiac dysfunction caused by cardiac amyloidosis. Subjects will receive up to 6 courses of Anti-SAP treatment. Maximum total duration for a subject in the study is approximately 18 months.
Interventions
- DRUG GSK2315698 (CPHPC)
- BIOLOGICAL GSK2398852 (anti-SAP mAb)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2017-07-10 |
| Est. Completion | 2019-01-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03044353
The ClinicalTrials.gov registry entry for NCT03044353 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which GSK2315698 (CPHPC) is the first listed.
NCT03044353 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03044353 about?
NCT03044353 is a clinical study titled "Multiple Treatment Session Study to Assess GSK2398852 Administered Following and Along With GSK2315698". The study is intended to evaluate whether monthly repeated courses of administration of GSK2315698 followed by GSK2398852 is associated with a reduction in cardiac amyloid load in patients with cardiac amyloidosis, monitored by cardiac magnetic resonance imaging (CMR) and echocardiography (ECHO), an...
What is the current status of trial NCT03044353?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2017-07-10. Estimated completion is 2019-01-03.
What interventions are being tested in trial NCT03044353?
The interventions under investigation include: GSK2315698 (CPHPC) (DRUG), GSK2398852 (anti-SAP mAb) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03044353?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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