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Part II: Granulocyte-Colony Stimulating Factor Adjunct Therapy for Biliary Atresia

NCT04373941 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2023-09-08

No results posted yet for this study

Summary

The Investigators propose to test the hypothesis that GCSF enhances the clinical outcome of biliary atresia in a multi-institutional Phase 2 trial to prospectively evaluate the safety and efficacy of GCSF in each of the 2 groups of newly diagnosed BA patients: KBA (i.e., Kasai-operated) or NoK (i.e., patients who did not undergo Kasai surgery). Subjects who participate in the trial will be followed for 2 years.

Conditions

  • Biliary Atresia

Interventions

DRUG

Filgrastim

G-CSF is a glycoprotein produced by monocytes, fibroblasts, and endothelial cells. Filgrastim is a human granulocyte colony stimulating factor (G-CSF) produced by recombinant DNA technology with NEUPOGEN® as the Amgen Inc. trademark for filgrastim. G-CSF regulates the production, proliferation and differentiation of neutrophils and hematopoietic stem cell precursors within the bone marrow leading to dose-dependent increase in circulating neutrophils and hematopoietic stem cells in the blood. It is indicated to reduce the incidence of infection in patients with severe neutropenia, for neutrophil recovery in neutropenic patients with bone marrow depletion, to mobilize hematopoietic progenitor stem cell for collection by leukapheresis in hematopoietic stem cell transplantation.

Sponsors & Collaborators

  • T Rose Clinical, Inc.

    collaborator UNKNOWN

  • Big Leap Research

    collaborator OTHER

  • Prometheus USA

    collaborator UNKNOWN

  • Holterman, Ai-Xuan, M.D.

    lead INDIV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Days
Max Age
180 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2024-08-31
Completion
2025-10-31
FDA Drug
Yes

Countries

  • United States
  • Pakistan
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs

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 NCT04373941 on ClinicalTrials.gov