Phase III study of HLC-001

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2033250788

Enrollment

Registered

2026-03-09

Start date

2026-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Steroid refractory non-infectious pulmonary complications (idiopathic pneumonia syndrome) after HSCT

Interventions

HLC-001 or placebo (0.5 mL/kg) is basically administrated intravenously twice a week (1 cycle) x 2cycles (total 4 administration). If safety is confirmed and efficacy is insufficient after the complet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with non-infectious pulmonary complications (idiopathic pneumonia syndrome) after HSCT diagnosed based on the American Thoracic Society (ATS) criteria. 2. Patients with steroid refractory IPS.

Exclusion criteria

Exclusion criteria: 1. Patients with apparent active pulmonary infections judged by principal investigator or sub investigator. 2. Patients on mechanical ventilation or non-invasive positive pressure ventilation (NPPV).

Design outcomes

Primary

Measure	Time frame
Progression free survival	—

Secondary

Measure	Time frame
Overall survival	—

Contacts

Public ContactPublic relations

Mochida Pharmaceutical Co., Ltd.

webmaster@mochida.co.jp+81-3-3225-6303

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026