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

PHASE2RecruitingINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

September 1, 2023

Primary Completion Date

August 31, 2024

Study Completion Date

October 31, 2025

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.

Trial Locations (4)

97239

NOT_YET_RECRUITING

Oregon Health & Science University (OHSU), Portland

Unknown

NOT_YET_RECRUITING

Aga Khan University, Karachi

RECRUITING

Nation Children's Hospital, Hanoi

ENROLLING_BY_INVITATION

Children Hospital 1, Ho Chi Minh City

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

T Rose Clinical, Inc.

UNKNOWN

collaborator

Big Leap Research

OTHER

collaborator

Prometheus USA

UNKNOWN

lead

Holterman, Ai-Xuan, M.D.

INDIV

NCT04373941 - Part II: Granulocyte-Colony Stimulating Factor Adjunct Therapy for Biliary Atresia | Biotech Hunter | Biotech Hunter