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Efficacy and Safety of LFG316 in Transplant Associated Microangiopathy (TAM) Patients

NCT02763644 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2021-01-05

Study results available
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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

Conditions

  • Transplant Associated Microangiopathy TAM

Interventions

DRUG

LFG316 active drug

LFG316

OTHER

Standard of care treatment

SoC (site specific)

Sponsors & Collaborators

Principal Investigators

  • Christoph Bucher · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-22
Primary Completion
2017-02-10
Completion
2017-06-30
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02763644 on ClinicalTrials.gov