WHO ICTRP trial
A Randomized, Double-Blind, Parallel Design, Repeat Dose, 2-arm, Multicenter…
EUCTR2021-005071-40-CZ · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2021-005071-40-CZ |
|---|---|
| Public title | A Randomized, Double-Blind, Parallel Design, Repeat Dose, 2-arm, Multicenter Study Comparing the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profiles of AVT03 and US-Prolia® in Postmenopausal Women with Osteoporosis, ALVOBOND |
| Scientific title | A Randomized, Double-Blind, Parallel Design, Repeat Dose, 2-arm, Multicenter Study Comparing the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profiles of AVT03 and US-Prolia® in Postmenopausal Women with Osteoporosis, ALVOBOND - ALVOBOND |
| Primary sponsor | Alvotech Swiss AG |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | Czech Republic;Czechia;Poland;South Africa;Georgia;Bulgaria |
| Conditions | Osteoporosis MedDRA version: 20.0 Level: PT Classification code 10031282 Term: Osteoporosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] |
| Interventions | Product Name: denosumab Product Code: AVT03 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Denosumab CAS Number: 615258-40-7 Current Sponsor code: AVT03 Concentration unit: mg/ml… |
| Registration date | Apr 25, 2022 |
| Target size | 532 |
| Secondary IDs | AVT03-GL-C01 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: