Safety and Tolerability Trial of Inhaled Alpha1-Proteinase Inhibitor (Human), Hydrophobic Chromatography Process (Alpha-1 HC) in Subjects With Cystic Fibrosis
Public ClinicalTrials.gov record NCT01684410. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Three Week Dose Escalation, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety and Tolerability of 100 mg or 200 mg of Inhaled Alpha-1 HC, Once a Day in Subjects With Cystic Fibrosis.
Study identification
- NCT ID
- NCT01684410
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Grifols Therapeutics LLC
- Industry
- Enrollment
- 30 participants
Conditions and interventions
Conditions
Interventions
- Alpha-1 HC 100 mg Biological
- Placebo Biological
- Alpha-1 HC 200 mg Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2012
- Primary completion
- Sep 30, 2013
- Completion
- Sep 30, 2013
- Last update posted
- Feb 7, 2016
2012 – 2013
United States locations
- U.S. sites
- 6
- U.S. states
- 6
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| National Jewish Hospital | Denver | Colorado | 80206 | — |
| Children's Hospital Boston | Boston | Massachusetts | 02115 | — |
| UNC at Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01684410, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 7, 2016 · Synced Jul 24, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01684410 live on ClinicalTrials.gov.