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NCT04120506
Long Term Impact of Rapid Intravenous Infusion of Velaglucerase Alfa (VPRIV)
Phase 4 trial testing VPRIV in Gaucher Disease, Type 1 in 15 participants. Completed in 1 January 2022.
20 January 2017
Quick facts
| Lead sponsor | Shaare Zedek Medical Center |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 10 January 2016 |
| Primary completion | 20 January 2017 |
| Estimated completion | 1 January 2022 |
Drugs / interventions tested
- VPRIV (VELAGLUCERASE ALFA) — full drug profile →
Conditions studied
- Gaucher Disease, Type 1 — all drugs for Gaucher Disease, Type 1 →
Sponsor
Shaare Zedek Medical Center
Who can join
Adults 6 to 75, any sex, with Gaucher Disease, Type 1. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: In order to allow our satisfied patients, who have successfully completed 24 months of rapid intravenous infusion of Velaglucerase alfa (VPRIV), to continue with the 10 minutes IV therapy, the clinical trial framework must be extended; and this extension is important for the assessment of long term benefit (up to 5 years) of this regimen of administration of Velaglucerase alfa.. Suggested trial: An additional 36 months home therapy follow up of safety and efficacy of rapid intravenous infusion of Velaglucerase alfa (VPRIV) in adult patients with type 1 Gaucher disease. Patients must have completed the prior 4 parts / 24 months of the protocol before enrolling into this extension phase ("Part 5") and have provided a new consent before entering PART 5 of the study. Patients must not have experienced clinically significant AEs, including allergic reactions, in any of the prior study parts of this protocol to be eligible to participate, and have maintained stability in the key disease features. All infusions of 10' will be given in the context of home therapy. "Clinically significant" AEs will be determined by the PI using standard description of AEs as previously described at phase 3, and if necessary will support withdrawal of the patient from the study.
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 NCT04120506
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Related trials
Other trials of VPRIV
Trials testing the same drug.
- NCT03702361 — Rapid Intravenous Infusion of Velaglucerase Alfa (VPRIV) in Treatment-naive Patients With Type 1 Gaucher Disease · Phase 4 · completed
Other recruiting trials for Gaucher Disease, Type 1
Currently open trials in the same condition.
- NCT05487599 — A Clinical Trial of PR001 (LY3884961) in Patients With Peripheral Manifestations of Gaucher Disease (PROCEED) · Phase 1, PHASE2 · recruiting
Other Shaare Zedek Medical Center trials
Trials by the same sponsor.
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- NCT05841953 — The Use of Electrical Stimulation to Increase Anal Pressures · NA · unknown
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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 NCT04120506 (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 Shaare Zedek Medical Center
- Last refreshed: 28 October 2022
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/NCT04120506.
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