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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 is a Phase 2 study that has completed, run by Grifols Therapeutics. The registered enrollment target is 30 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01684410
The ClinicalTrials.gov registry entry for NCT01684410 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Grifols Therapeutics, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01684410 reports 0 study locations.
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.
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