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NCT01684410 · ClinicalTrials.gov registry record · Phase 2
Safety and Tolerability Trial of Inhaled Alpha1-Proteinase Inhibitor (Human), Hydrophobic Chromatography Process (Alpha-1 HC) in Subjects With Cystic Fibrosis
A Phase 2 study, sponsored by Grifols Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT01684410: Completed Phase 2 study, sponsored by Grifols Therapeutics.
NCT01684410 is a Phase 2 study that has completed, run by Grifols Therapeutics. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01684410, a Phase 2 study, has completed, sponsored by Grifols Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
This was a randomized, double-blind, placebo-controlled, dose escalation study to assess the safety and tolerability of 100 mg and 200 mg of inhaled Alpha-1 HC administered once a day for three weeks in subjects aged 18 years and older with cystic fibrosis (CF). The treatment duration in this study was intended to provide multi-dose safety information prior to proceeding to longer durations of exposure.
Primary Outcome
adverse event frequency
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Alpha-1 HC 100 mg
- BIOLOGICAL Alpha-1 HC 200 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2012-08 |
| Est. Completion | 2013-10 |
| Phase | Phase 2 |
What the finished NCT01684410 record still lists
NCT01684410 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01684410 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01684410 about?
NCT01684410 is a clinical study titled "Safety and Tolerability Trial of Inhaled Alpha1-Proteinase Inhibitor (Human), Hydrophobic Chromatography Process (Alpha-1 HC) in Subjects With Cystic Fibrosis". This was a randomized, double-blind, placebo-controlled, dose escalation study to assess the safety and tolerability of 100 mg and 200 mg of inhaled Alpha-1 HC administered once a day for three weeks in subjects aged 18 years and older with cystic fibrosis (CF). The treatment duration in this study ...
What is the current status of trial NCT01684410?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2012-08. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01684410?
The interventions under investigation include: Placebo (BIOLOGICAL), Alpha-1 HC 100 mg (BIOLOGICAL), Alpha-1 HC 200 mg (BIOLOGICAL).
Who is sponsoring clinical trial NCT01684410?
This trial is sponsored by Grifols Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01684410's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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