Extension Study, Pilot, Compassionate Use of Azacitidine 300 mg Film Coated Tablets for Acute Myeloid Leukaemia (AML) Patients

Active not recruiting 20 enrolled Hikma Pharmaceuticals LLC

NaSingle-groupOpen-labelTreatment

Summary

Extension study, pilot, single-arm, compassionate use of Hikma Azacitidine 300 mg Film coated tablets test product for the Acute Myeloid Leukaemia (AML) patients who completed Hikma bioequivalence study with protocol number: HIK-AZA-2023-01

Timeline

Start: 2025-04-29
Primary completion: 2026-05
Completion: 2026-05

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Azacitidine	Other / unclassified	300 mg	—

Extension Study, Pilot, Compassionate Use of Azacitidine 300 mg Film Coated Tablets for Acute Myeloid Leukaemia (AML) Patients

Summary

Timeline

Drugs

Indications