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NCT02763644 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of LFG316 in Transplant Associated Microangiopathy (TAM) Patients
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT02763644: Clinical Trial Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT02763644 is a Phase 2 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02763644, a Phase 2 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
This was a randomized, SoC-controlled, open-label, multi-center study in patients with TAM after hematopoietic precursor cell transplantation (HPCT) . Study consisted of up to 28 days of screening period, 16 weeks treatment period that can be extended to 45 weeks.Approximately 40 patients was to be randomized to receive SoC or LFG316 plus SoC. Patients was included in the study if they have diagnosis of TAM and poor prognostic markers. This trial was terminated: LFG316, a monoclonal antibody inhibitor of complement factor 5 (C5), had been studied in seven patients with transplantation-associated microangiopathy (TAM). Due to low confidence of clinical benefit, this study was closed
Primary Outcome
Hematological response rate was to be assessed at 17 weeks. However, due to early termination and with too few patients for statistical inference, the comparison between the two treatment arms LFG316 and SoC was not performed, and only descriptive statistics at different visits are provided for schistocytes Schistocytes \<2/microscopic high power field (HPF) showed a hematological response
Interventions
- OTHER Standard of care treatment
- DRUG LFG316 active drug
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2016-04-22 |
| Est. Completion | 2017-06-30 |
| Phase | Phase 2 |
Why NCT02763644 stopped before completion
NCT02763644 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard of care treatment is the first listed.
NCT02763644 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02763644 about?
NCT02763644 is a clinical study titled "Efficacy and Safety of LFG316 in Transplant Associated Microangiopathy (TAM) Patients". This was a randomized, SoC-controlled, open-label, multi-center study in patients with TAM after hematopoietic precursor cell transplantation (HPCT) . Study consisted of up to 28 days of screening period, 16 weeks treatment period that can be extended to 45 weeks.Approximately 40 patients was to be...
What is the current status of trial NCT02763644?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2016-04-22. Estimated completion is 2017-06-30.
What interventions are being tested in trial NCT02763644?
The interventions under investigation include: Standard of care treatment (OTHER), LFG316 active drug (DRUG).
Who is sponsoring clinical trial NCT02763644?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02763644's enrollment target sits among peer trials
7 1996th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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