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NCT03781414 · ClinicalTrials.gov registry record · Phase 2

Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Liver Transplant Recipients With Additional 12-month Follow-up and Long-term Extension

A Phase 2 study, sponsored by Novartis Pharmaceuticals.

Terminated
Registry status
Phase 2
Development phase
129
Enrollment target

NCT03781414 is a Phase 2 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 129 participants.

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The verdict

NCT03781414, a Phase 2 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.

TERMINATED
Registry status
Phase 2
Development phase
129 participants
Enrollment target

Study Summary

This was a multicenter, open-label, active-controlled study to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of two CFZ533 maintenance doses in de novo liver transplant recipients.

Interventions

  • BIOLOGICAL CFZ533
  • DRUG Tacrolimus - MMF - corticosteroids

Trial Details

FieldValue
Enrollment Target 129 participants
Start Date 2019-10-07
Est. Completion 2023-04-20
Phase Phase 2

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT03781414

The ClinicalTrials.gov registry entry for NCT03781414 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 129 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which CFZ533 is the first listed.

NCT03781414 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03781414 about?

NCT03781414 is a clinical study titled "Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Liver Transplant Recipients With Additional 12-month Follow-up and Long-term Extension". This was a multicenter, open-label, active-controlled study to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of two CFZ533 maintenance doses in de novo liver transplant recipients.

What is the current status of trial NCT03781414?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 129 participants. The study started on 2019-10-07. Estimated completion is 2023-04-20.

What interventions are being tested in trial NCT03781414?

The interventions under investigation include: CFZ533 (BIOLOGICAL), Tacrolimus - MMF - corticosteroids (DRUG).

Who is sponsoring clinical trial NCT03781414?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.