NCT03482752Phase 3Terminated

Safety Extension Trial of Inhaled Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2021-01-14Actual

Enrollment · participants60Actual

Source updated2024-07-03Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Autoimmune Pulmonary Alveolar Proteinosis

Treatments or interventions studied

MolgramostimDrugAlso known as Recombinant human GM-CSF

Primary outcomes · main study measures

Read the study measures

measure: Number of Treatment-emergent Adverse Events (TEAEs); description: The primary objective of this trial was safety assessed by adverse event (AE) reporting. Definitions and reporting procedures for AEs were done according to current regulatory standards. AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns. Treatment-emergent was defined as events occurring on study drug and up to 7 days after last dose of study drug.; timeFrame: 139 weeks; measure: Number of Serious TEAEs; description: Serious TEAEs were defined as any untoward medicinal occurrence or effect that at any dose: * Results in death * Is life-threatening * Requires hospitalisation or prolongation of existing hospitalisation * Results in persistent or significant disability or incapacity * Is a congenital abnormality or birth defect * May jeopardise the participant or may require medical intervention to prevent one or more of the outcomes listed above (Important Medical Events).; timeFrame: 139 weeks; measure: Number of Treatment-emergent Adverse Drug Reactions (ADRs); description: All AEs were assessed by the investigator for causality (unlikely, possible, probable, not applicable) according to current regulatory standards. AEs which had a 'possible' or 'probable' causality were classified as ADRs.; timeFrame: 139 weeks; measure: Number of TEAEs Leading to Treatment Discontinuation; timeFrame: 139 weeks

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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