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NCT00467831 · ClinicalTrials.gov registry record · Phase 1
Pilot Study of a Multi-Drug Regimen for Severe Pulmonary Fibrosis in Hermansky-Pudlak Syndrome
A Phase 1 study, sponsored by National Human Genome Research Institute (NHGRI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT00467831: Clinical Trial Phase 1 study, sponsored by National Human Genome Research Institute (NHGRI).
NCT00467831 is a Phase 1 study that was terminated before completion, run by National Human Genome Research Institute (NHGRI). The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00467831, a Phase 1 study, was terminated before completion, sponsored by National Human Genome Research Institute (NHGRI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
This study will examine whether five drugs (pravastatin, Losartan, Zileuton, N-acetylcysteine and erythromycin) used together can slow the course of pulmonary fibrosis (scarring of the lung tissue) in patients with Hermansky-Pudlak Syndrome (HPS). Patients with this disease have decreased skin color (albinism), bleeding problems, and sometimes colon problems. Two of the known types of Hermansky Pudlak syndrome, type 1 and type 4, are at high risk of pulmonary fibrosis between the ages of 30 and 50. Patients 18 to 70 years of age who have Hermansky-Pudlak Syndrome with a serious loss of lung function due to pulmonary fibrosis may be eligible for this study. Participants begin taking pravastatin on study day 2 and start a new drug every 3 days. Patients who experience no problems with the medicines return home and continue on the drugs for the next 2 years. They return to the NIH Clinical Center every 3 months for a medical history, physical examination, and blood, urine and lung function tests. CT and bone density scans are done every year. The study may continue for up to 3 years.
Primary Outcome
The number of subjects surviving after 24 months on study.
Interventions
- DRUG Losartan
- DRUG N-Acetylcysteine
- DRUG Erythromycin
- DRUG Pravastatin
- DRUG Zileuton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2007-04 |
| Est. Completion | 2012-11 |
| Phase | Phase 1 |
Why NCT00467831 stopped before completion
NCT00467831 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 5 interventions - of which Losartan is the first listed.
NCT00467831 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00467831 about?
NCT00467831 is a clinical study titled "Pilot Study of a Multi-Drug Regimen for Severe Pulmonary Fibrosis in Hermansky-Pudlak Syndrome". This study will examine whether five drugs (pravastatin, Losartan, Zileuton, N-acetylcysteine and erythromycin) used together can slow the course of pulmonary fibrosis (scarring of the lung tissue) in patients with Hermansky-Pudlak Syndrome (HPS). Patients with this disease have decreased skin color...
What is the current status of trial NCT00467831?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2007-04. Estimated completion is 2012-11.
What interventions are being tested in trial NCT00467831?
The interventions under investigation include: Losartan (DRUG), N-Acetylcysteine (DRUG), Erythromycin (DRUG), Pravastatin (DRUG), Zileuton (DRUG).
Who is sponsoring clinical trial NCT00467831?
This trial is sponsored by National Human Genome Research Institute (NHGRI), which has 185 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00467831's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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