Trial · NCT04204252
Phase III, Efficacy and Safety of "Kamada-AAT for Inhalation"
NCT04204252, Phase 3, Terminated, Kamada, Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase III, Efficacy and Safety of "Kamada-AAT for Inhalation". Trials, record NCT04204252. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04204252
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase III, Efficacy and Safety of "Kamada-AAT for Inhalation"
- NCT number
- NCT04204252
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 98 participants, actual
- Lead sponsor
- Kamada, Ltd.
- Conditions
- Alpha 1-Antitrypsin Deficiency
- Interventions
- Alpha 1-Antitrypsin, Placebo
- First posted
- 2019-12-18
- Last updated
- 2026-08-12
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | FEV1 post bronchodilator | 104 weeks | Change from baseline in post bronchodilator FEV1 at 104 weeks |
| Secondary | CT densitometry whole-lung 15th percentile lung density (PD15) at total lung capacity (TLC). | 104 weeks | Change from baseline over 104 weeks of treatment in CT densitometry whole-lung 15th percentile lung density (PD15) at total lung capacity (TLC). |
| Secondary | FEV1 % of predicted | 104 weeks | Change from baseline over 104 weeks of treatment in FEV1 % of predicted |
| Secondary | FEV1/FVC % | 104 weeks | Change from baseline over 104 weeks of treatment in FEV1/FVC % |
| Secondary | Exacerbations | 104 weeks | Annual rate of exacerbations by severity and duration |
| Secondary | 6 minute walk test | 104 weeks | Change from Baseline in the distance walked in six minutes |
| Other | TEAEs | 130 weeks | Rate and severity of adverse events during treatment emergent adverse events (TEAEs), adverse events of special interest (AESIs) and serious adverse events (SAEs) during treatment and follow-up period \[Safety Outcome\] |
| Other | PiM | 130 weeks | Plasma M-type AAT specific (PiM) levels evaluated as function of exposure time, antibody response (positive vs. negative), and antibody titers. \[Safety Outcome\] |
| Other | ADA/nADA | 130 weeks | Rate and titers of binding and neutralizing AAT antibodies (ADA/nADA) in plasma \[Safety Outcome\] |
| Other | ECG | 130 weeks | Electrocardiogram \[Safety Outcome\] will be classified as normal or abnormal. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37665565 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04204252
GET https://conductscience.org/api/trials/v1/NCT04204252/registered