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NCT03419819
Evaluation of PKU Sphere
NA trial testing PKU Sphere in Phenylketonurias in 28 participants. Completed in 21 May 2019.
21 May 2019
Quick facts
| Lead sponsor | Vitaflo International, Ltd |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 28 |
| Start date | 1 May 2018 |
| Primary completion | 21 May 2019 |
| Estimated completion | 21 May 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- PKU Sphere
Conditions studied
- Phenylketonurias — all drugs for Phenylketonurias →
Sponsor
Vitaflo International, Ltd
Who can join
3 and older, any sex, with Phenylketonurias. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A prospective, open-label study of PKU Sphere in patients with PKU following a phenylalanine restricted therapeutic diet.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03419819
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of PKU Sphere
Trials testing the same drug.
- NCT03771391 — A 16 Week Study Evaluating the Introduction of a GMP Based Protein Substitute in Participants With PKU · NA · completed
Other recruiting trials for Phenylketonurias
Currently open trials in the same condition.
- NCT06332807 — AAV Gene Therapy Clinical Study in Adult Classic PKU (PHEdom) · Phase 1, PHASE2 · recruiting
- NCT06560736 — Development of Novel Psychological Assessment Tools and Anxiety Intervention for Phenylketonuria · NA · recruiting
- NCT06718842 — Walking Program in Fatty Liver Children With Phenylketonuria · NA · recruiting
- NCT06687733 — Safety and Efficacy Study of NGGT002 in cPKU Adult Subjects · Phase 1, PHASE2 · recruiting
- NCT06061614 — Safety and Efficacy Study of NGGT002 in PKU Adult Subjects · EARLY_PHASE1 · recruiting
Other Vitaflo International, Ltd trials
Trials by the same sponsor.
- NCT05995717 — Evaluation of PKU UP · NA · active not recruiting
- NCT04898829 — Evaluation of PKU Explore France · NA · completed
- NCT04761588 — Evaluation of TYR Sphere in France · NA · completed
- NCT05096988 — Evaluation of PKU Sphere Liquid · NA · completed
- NCT05051657 — Evaluation of the Express Plus Range · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03419819 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Vitaflo International, Ltd
- Last refreshed: 16 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03419819.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing