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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00467831
The ClinicalTrials.gov registry entry for NCT00467831 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Human Genome Research Institute (NHGRI), which has 185 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Losartan is the first listed.
NCT00467831 reports 0 study locations.
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.
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