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NCT03559387
Randomized Phase 2, Dose-finding Efficacy, Safety Study of ANF-RHO™ Versus Neulasta® in Chemotherapy-Induced Neutropenia
Phase 2 trial testing ANF-RHO™ in Chemotherapy-induced Neutropenia in 9 participants. Terminated before completion.
18 April 2018
Quick facts
| Lead sponsor | Prolong Pharmaceuticals |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 9 |
| Start date | 3 August 2017 |
| Primary completion | 18 April 2018 |
| Estimated completion | 22 May 2018 |
| Sites | 8 locations across France, Netherlands |
Drugs / interventions tested
- ANF-RHO™
- Neulasta®
Conditions studied
- Chemotherapy-induced Neutropenia — all drugs for Chemotherapy-induced Neutropenia →
Sponsor
Prolong Pharmaceuticals — full company profile →
Who can join
18 and older, female only, with Chemotherapy-induced Neutropenia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Randomized, Open-Label study to determine the dose, efficacy, safety and pharmacokinetic profile of ANF-RHO™ with once-per-cycle injection in comparison with Neulasta in Breast Cancer patients at high risk of developing Chemotherapy-Induced Neutropenia
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03559387
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Prolong Pharmaceuticals trials
Trials by the same sponsor.
- NCT04677777 — Safety Study of PP-007 in Subjects With Acute Ischemic Stroke · Phase 1 · completed
- NCT02950857 — A Study of EPEG in Beta Thalassemia Patients · Phase 1 · completed
- NCT02437422 — Study to Assess the Safety and Impact on Humoral Sensitization of SANGUINATE in Patients With End Stage Renal Disease · Phase 1 · 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 NCT03559387 (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 Prolong Pharmaceuticals
- Last refreshed: 12 February 2019
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/NCT03559387.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing