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NCT00590538 · ClinicalTrials.gov registry record · Phase 1
Phenylbutyrate/Genistein Duotherapy in Delta F508-Heterozygotes (for Cystic Fibrosis)
A Phase 1 study, sponsored by Children's Hospital of Philadelphia.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT00590538: Clinical Trial Phase 1 study, sponsored by Children's Hospital of Philadelphia.
NCT00590538 is a Phase 1 study that was terminated before completion, run by Children's Hospital of Philadelphia. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00590538, a Phase 1 study, was terminated before completion, sponsored by Children's Hospital of Philadelphia.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
The purpose of this research study is to test a new combination of medicines, Phenylbutyrate and Genistein, to determine if they could be used to treat cystic fibrosis (CF). The most common genetic mutation found in patients with CF is called Delta F508. Due to this mutation, there is a lack of salt (chloride) movement in your nose, sinuses, lungs, intestines, pancreas and sweat glands. This lack of movement causes the clinical manifestations of the disease. Although Phenylbutyrate has been extensively used to treat patients with rare metabolic diseases, Phenylbutyrate is an investigational drug for the purpose of this study. Genistein is a naturally occurring substance that is found in food products such as soy and tofu, but is also an investigational drug for this study. When used together, both drugs may be able to restore normal chloride and salt (water) movements in body organs and glands in people with CF. We will be studying salt and water movement in the nose by a technique called nasal transepithelial potential difference (NPD).
Primary Outcome
The basis of analysis for the primary outcome measure will be the comparison of data from both the standard CF Nasal Potential Difference (NPD) Protocol compared to a modified NPD protocol including the perfusion of Genistein. The NPD response will be compared from baseline to after study drug. NPD responses will then be compared between the Phenylbutrate group and the placebo group.
Interventions
- DRUG Placebo
- DRUG Sodium 4-Phenylbutyrate
- DRUG Genistein (Unconjugated Isoflavones 100)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2003-02 |
| Est. Completion | 2008-12 |
| Phase | Phase 1 |
Why NCT00590538 stopped before completion
NCT00590538 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00590538 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00590538 about?
NCT00590538 is a clinical study titled "Phenylbutyrate/Genistein Duotherapy in Delta F508-Heterozygotes (for Cystic Fibrosis)". The purpose of this research study is to test a new combination of medicines, Phenylbutyrate and Genistein, to determine if they could be used to treat cystic fibrosis (CF). The most common genetic mutation found in patients with CF is called Delta F508. Due to this mutation, there is a lack of salt...
What is the current status of trial NCT00590538?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2003-02. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00590538?
The interventions under investigation include: Placebo (DRUG), Sodium 4-Phenylbutyrate (DRUG), Genistein (Unconjugated Isoflavones 100) (DRUG).
Who is sponsoring clinical trial NCT00590538?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00590538's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 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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