A Phase 2 Study of the Effects of 6R-BH4 in Subjects With Sickle Cell Disease
Public ClinicalTrials.gov record NCT00445978. 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 Phase 2a, Multicenter, Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, and Efficacy of 6R-BH4 in Subjects With Sickle Cell Disease
Study identification
- NCT ID
- NCT00445978
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- BioMarin Pharmaceutical
- Industry
- Enrollment
- 32 participants
Conditions and interventions
Conditions
Interventions
- Sapropterin Dihydrochloride Drug
Drug
Eligibility (public fields only)
- Age range
- 15 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
- Apr 30, 2007
- Primary completion
- Jul 31, 2008
- Completion
- May 31, 2009
- Last update posted
- Feb 24, 2021
2007 – 2009
United States locations
- U.S. sites
- 12
- U.S. states
- 9
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Washington D.C. | District of Columbia | 20060 | — |
| Not listed | Augusta | Georgia | 30912 | — |
| Not listed | Savannah | Georgia | 31404 | — |
| Not listed | Indianapolis | Indiana | 46260 | — |
| Not listed | Detroit | Michigan | 48201 | — |
| Not listed | Flint | Michigan | 48503 | — |
| Not listed | Hackensack | New Jersey | 07601 | — |
| Not listed | Chapel Hill | North Carolina | 27599 | — |
| Not listed | Philadelphia | Pennsylvania | 19134 | — |
| Not listed | Galveston | Texas | 77555 | — |
| Not listed | Norfolk | Virginia | 23507 | — |
| Not listed | Richmond | Virginia | 23298 | — |
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 NCT00445978, 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 24, 2021 · Synced Jun 26, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00445978 live on ClinicalTrials.gov.