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Safety Extension Trial of Inhaled Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis

NCT03482752 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-07-03

Study results available
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Summary

SAV006-03 is an open-label extension study for participants who had completed the IMPALA study.

At the baseline visit, eligible participants may continue or re-start treatment with 300 µg inhaled molgramostim (recombinant human Granulocyte-Macrophage Colony Stimulating Factor; GM-CSF) administered intermittently in cycles of seven days molgramostim, administered once daily, and seven days off treatment.

Participants will be treated with inhaled molgramostim for up to 36 months.

During the trial, whole lung lavage will be applied as rescue therapy.

Conditions

Interventions

DRUG

Molgramostim

300 µg inhaled molgramostim in cycles of once daily administration for 7 days, then 7 days off treatment.

Sponsors & Collaborators

Principal Investigators

  • Francesco Bonella, Prof. · Interstitial and Rare Lung Disease Unit, Ruhrlandklinik University Hospital, Essen, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-16
Primary Completion
2021-01-14
Completion
2021-01-14

Countries

  • Denmark
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • Netherlands
  • Russia
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT03482752 on ClinicalTrials.gov