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NCT04112797: HIPNOS
Prospective Observational Study to Evaluate the Safety of Treatment With A"LLERGOVAC® HIMENÓPTEROS" in Patients Sensitized to This Venom
trial testing Allergovac himenoptera in Allergy to Himenoptera Venom in 50 participants. Status unknown.
1 November 2023
Quick facts
| Lead sponsor | Roxall Medicina España S.A |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 50 |
| Start date | 23 May 2019 |
| Primary completion | 1 November 2023 |
| Estimated completion | 1 November 2023 |
| Sites | 8 locations across Spain |
Drugs / interventions tested
- Allergovac himenoptera — full drug profile →
Conditions studied
- Allergy to Himenoptera Venom — all drugs for Allergy to Himenoptera Venom →
Sponsor
Roxall Medicina España S.A — full company profile →
Who can join
14 and older, any sex, with Allergy to Himenoptera Venom. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Number of participants with treatment-related adverse events as assessed by WAO classification
Time frame: During 1 year
All adverse events ocurred during the study Will be collected and clasified following the WAO recommendations. The percentages Will be exposed by number of patients and by dose administrations.
Sponsor's own description
It is a safety and tolerability study of Allergovac Himenopteros in patients sensitized to Apis mellifera, Polistes Dominula or Vespula spp. To get this aim all adverse reactions will be recorded through the study. In addition, it will be evaluated the treatment efficacy with the re-sting after a year of treatment.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04112797
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Roxall Medicina España S.A trials
Trials by the same sponsor.
- NCT03821077 — Study to Evaluate the Efficacy and Safety of "Allergovac Poliplus" in Polysensitized Patients With Allergic Rhinitis/Rhi · completed
- NCT02844842 — Evaluation of Tolerability and Safety of "Allergovac Poliplus" in Polysensitized Patients With Rhinitis or Allergic Rhin · 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 NCT04112797 (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 Roxall Medicina España S.A
- Last refreshed: 16 March 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/NCT04112797.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing