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12 Diseases |  |
2 Trials |
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2 Trials |  |
17 News |  |
- | recombinant ectodysplasin A1 (APO200) / Valerio Therap, Pierre Fabre
Trial primary completion date: EDELIFE: Intraamniotic Administrations of ER004 to Male Subjects With X-linked Hypohidrotic Ectodermal Dysplasia (clinicaltrials.gov) - Aug 27, 2024
P2, N=20, Recruiting, Sponsor: EspeRare Foundation
Trial primary completion date: Jul 2024 --> Apr 2025
- || recombinant ectodysplasin A1 (APO200) / Onxeo, Pierre Fabre
P2 data, Journal: Protocol for the Phase 2 EDELIFE Trial Investigating the Efficacy and Safety of Intra-Amniotic ER004 Administration to Male Subjects with X-Linked Hypohidrotic Ectodermal Dysplasia. (Pubmed Central) - Jan 22, 2023
In order to confirm these results, we started the EDELIFE trial, a prospective, open-label, genotype-match controlled, multicentre clinical study to investigate the efficacy and safety of intra-amniotic ER004 administration as a prenatal treatment for male subjects with XLHED. This article summarises the rationale, the study protocol, ethical issues of the trial, and potential pitfalls.
- | recombinant ectodysplasin A1 (APO200) / Valerio Therap, Pierre Fabre
Trial completion date, Trial primary completion date: EDELIFE: Intraamniotic Administrations of ER004 to Male Subjects With X-linked Hypohidrotic Ectodermal Dysplasia (clinicaltrials.gov) - Oct 28, 2022
P2, N=20, Recruiting, Sponsor: EspeRare Foundation
This article summarises the rationale, the study protocol, ethical issues of the trial, and potential pitfalls. Trial completion date: Apr 2029 --> Jan 2029 | Trial primary completion date: Jun 2023 --> Jul 2024
- | recombinant ectodysplasin A1 (APO200) / Valerio Therap, Pierre Fabre
Enrollment open, Trial initiation date: EDELIFE: Intraamniotic Administrations of ER004 to Male Subjects With X-linked Hypohidrotic Ectodermal Dysplasia (clinicaltrials.gov) - Jan 24, 2022
P2, N=20, Recruiting, Sponsor: EspeRare Foundation
Trial completion date: Apr 2029 --> Jan 2029 | Trial primary completion date: Jun 2023 --> Jul 2024 Not yet recruiting --> Recruiting | Initiation date: Oct 2021 --> Feb 2022
- || recombinant ectodysplasin A1 (APO200) / Onxeo, Pierre Fabre
Clinical, Journal: Safety and immunogenicity of Fc-EDA, a recombinant ectodysplasin A1 replacement protein, in human subjects. (Pubmed Central) - Jul 30, 2021
Most importantly, there was no detectable immune response to the investigational drug in neonates treated by intravenous infusions and in infants who had received Fc-EDA in utero. In conclusion, the safety profile of this drug encourages further development of prenatal EDA1 replacement therapy.
- | recombinant ectodysplasin A1 (APO200) / Valerio Therap, Pierre Fabre
New P2 trial: EDELIFE: Intraamniotic Administrations of ER004 to Male Subjects With X-linked Hypohidrotic Ectodermal Dysplasia (clinicaltrials.gov) - Jul 28, 2021
P2, N=20, Not yet recruiting, Sponsor: EspeRare Foundation
- | APO200 / Onxeo
Journal: Prenatal Treatment of X-Linked Hypohidrotic Ectodermal Dysplasia using Recombinant Ectodysplasin in a Canine Model. (Pubmed Central) - Dec 25, 2019
The results suggested that a single or two temporally spaced injections of EDI200 prenatally might improve the clinical outcome in the dog model...These results exemplify the feasibility of ultrasound-guided intra-amniotic injections for treatment of developmental disorders, with improved formation of specific EDA1-dependent structures in dogs with XLHED. SIGNIFICANCE STATEMENT: N/A.
- recombinant ectodysplasin A1 (APO200) / Valerio Therap, Pierre Fabre
Enrollment closed: ECP-002e: Extension Study of XLHED-Affected Male Subjects Treated With EDI200 in Protocol ECP-002 (clinicaltrials.gov) - Apr 7, 2016
P=N/A, N=10, Active, not recruiting, Sponsor: Edimer Pharmaceuticals
SIGNIFICANCE STATEMENT: N/A. Recruiting --> Active, not recruiting
- recombinant ectodysplasin A1 (APO200) / Valerio Therap, Pierre Fabre
Trial completion, IO biomarker: Phase 2 Study to Evaluate Safety, Pharmacokinetics, Immunogenicity and Pharmacodynamics/Efficacy of EDI200 in Male Infants With X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED) (clinicaltrials.gov) - Jan 20, 2016
P2, N=6, Completed, Sponsor: Edimer Pharmaceuticals
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- recombinant ectodysplasin A1 (APO200) / Valerio Therap, Pierre Fabre
Enrollment closed, IO biomarker: Phase 2 Study to Evaluate Safety, Pharmacokinetics, Immunogenicity and Pharmacodynamics/Efficacy of EDI200 in Male Infants With X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED) (clinicaltrials.gov) - Sep 8, 2015
P2, N=6, Active, not recruiting, Sponsor: Edimer Pharmaceuticals
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- recombinant ectodysplasin A1 (APO200) / Valerio Therap, Pierre Fabre
Trial primary completion date, IO biomarker: Phase 2 Study to Evaluate Safety, Pharmacokinetics, Immunogenicity and Pharmacodynamics/Efficacy of EDI200 in Male Infants With X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED) (clinicaltrials.gov) - May 8, 2015
P2, N=6, Recruiting, Sponsor: Edimer Pharmaceuticals
Recruiting --> Active, not recruiting Trial primary completion date: Oct 2014 --> Dec 2015
- recombinant ectodysplasin A1 (APO200) / Valerio Therap, Pierre Fabre
Enrollment open: ECP-002e: Extension Study of XLHED-Affected Male Subjects Treated With EDI200 in Protocol ECP-002 (clinicaltrials.gov) - Mar 25, 2014
P=N/A, N=10, Recruiting, Sponsor: Edimer Pharmaceuticals
Trial primary completion date: Oct 2014 --> Dec 2015 Not yet recruiting --> Recruiting
- recombinant ectodysplasin A1 (APO200) / Valerio Therap, Pierre Fabre
Trial completion: A Phase 1, Open-label, Multicenter, Safety and Pharmacokinetic Study of EDI200 (clinicaltrials.gov) - Nov 24, 2013
P1, N=6, Completed, Sponsor: Edimer Pharmaceuticals
Not yet recruiting --> Recruiting Recruiting --> Completed
- recombinant ectodysplasin A1 (APO200) / Valerio Therap, Pierre Fabre
Enrollment open, IO biomarker: Phase 2 Study to Evaluate Safety, Pharmacokinetics, Immunogenicity and Pharmacodynamics/Efficacy of EDI200 in Male Infants With X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED) (clinicaltrials.gov) - Jul 2, 2013
P2, N=6, Recruiting, Sponsor: Edimer Pharmaceuticals
Recruiting --> Completed Active, not recruiting --> Recruiting
- recombinant ectodysplasin A1 (APO200) / Valerio Therap, Pierre Fabre
New P2 trial, IO biomarker: Phase 2 Study to Evaluate Safety, Pharmacokinetics, Immunogenicity and Pharmacodynamics/Efficacy of EDI200 in Male Infants With X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED) (clinicaltrials.gov) - Jan 23, 2013
P2, N=6, Recruiting, Sponsor: Edimer Pharmaceuticals
- recombinant ectodysplasin A1 (APO200) / Valerio Therap, Pierre Fabre
New P1 trial: A Phase 1, Open-label, Multicenter, Safety and Pharmacokinetic Study of EDI200 (clinicaltrials.gov) - Mar 25, 2012
P1, N=6, Completed, Sponsor: Edimer Pharmaceuticals