Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Temporarily halted
Participants planned
15
Countries
2
Sites
3
Type 1 Gaucher Disease (Peripheral/Non-neuronopathic Manifestations)
To evaluate the safety and tolerability of LY3884961
Key facts
- Sponsor
- Prevail Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Trial duration
- 6 Feb 2026 → ongoing
- Decision date (initial)
- 2023-09-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Eli Lilly & Company · Prevail Therapeutics, A Wholly Owned Subsidiary of Eli Lilly & Company
External identifiers
- EU CT number
- 2022-500281-10-02
- ClinicalTrials.gov
- NCT05487599
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy, Dose response
To evaluate the safety and tolerability of LY3884961
Secondary objectives 1
- To evaluate the clinical and biomarker effects of LY3884961 at predefined timepoints following infusion
Conditions and MedDRA coding
Type 1 Gaucher Disease (Peripheral/Non-neuronopathic Manifestations)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10075697 | Gaucher's disease type I | 100000004850 |
Study design 2 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Dose Finding Period Up to three dose-finding cohorts, each enrolling 3 patients. In the dose-finding cohorts, there is a 4-week stagger period between patients, both intra- and inter-cohort, to allow review of available safety, tolerability, and, to the extent available, clinical efficacy data by the Sponsor and independent data monitoring committee (iDMC).
|
Not Applicable | None | Cohort 1: 00 Cohort 2: 00 Cohort 3: 00 |
|
| 2 | Expansion Period One cohort enrolling up to 6 patients at the optimal dose level. The expansion cohort may initiate enrollment once dose-finding cohorts complete enrollment. Decision to implement a stagger, and if so what duration, in the expansion cohort will be made after review of the safety data from the dose-finding cohorts and in consultation with the iDMC.
Additionally, an exclusionary pre-existing anti-AAV9 titer level is applied to the initial dose finding cohorts, as outlined in the Exclusion Criteria Section 4.1.2 of protocol. Pending review of safety and efficacy data from the initial dose findings cohorts, and in consultation with the iDMC, this titer exclusion may be changed, adjusted, or removed from the subsequent expansion cohort.
To support the assessment of safety, tolerability, and immunogenicity of LY3884961, this stepwise approach allows careful evaluation of safety while limiting the number of patients potentially exposed to sub-therapeutic dose. The subsequent expansion cohort expands the number of patients treated at an optimal dose that has shown safety in at least 3 patients, providing additional safety data at this dose and allowing evaluation of efficacy data in a larger population of GD patients.
|
Not Applicable | None | Expansion Cohort: Dose Level to be determined |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1. Age ≥ 18years at the time of informed consent. 2. Bi-allelic pathogenic GBA1 variants must be centrally confirmed. 3. On ERT or SRT for at least 2 years and on a stable, maximum tolerated dose, for at least 3 months prior to screening. 4. Capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 5. Females and males will be eligible for this study. Men and women of childbearing potential must use a highly effective method of contraception consistently and correctly for the duration of the study, including the long-term follow-up. 6. Patients must agree to abstain from blood donations for at least the first year of the study; and must agree to abstain from tissue and organ donation for the duration of the study, including long-term follow-up.
Exclusion criteria 1
- 1. Clinically significant neurological signs and symptoms and/or behavioral disturbances. 2. Active and progressive bone disease expected to require surgical treatment in the next 6 months 3. History of total splenectomy or planned total splenectomy during the first 18 months of the study 4. Splenomegaly > 10 MN as evaluated by centrally read abdominal magnetic resonance imaging (MRI). 5. Evidence of clinically significant liver disease, fragile liver, or history of exposure to hepatotoxins 6. Thrombocytopenia with platelet count < 40 × 103 per μL 7. Severe hyperlipidemia (triglycerides > 1,000 mg/dL) 8. Current diagnosis of unstable or clinically significant cardiovascular conditions based on Investigator assessment 9. History of certain cancers within 5 years of Screening 10. Concomitant disease, condition or treatment which, in the opinion of the Investigator, would pose an unacceptable risk to the patient or interfere with the patient's ability to comply with study procedures or interfere with the conduct of the study. 11. Women, who are pregnant (i.e., positive serum or urine pregnancy result at Screening and or Check-in) or breastfeeding or intending to become pregnant during the course of the trial. 12. Use of any GD-related chaperone therapy within 4 weeks prior to Screening or expected need to initiate chaperone therapy during at least the first 18 months of the study 13. Any type of prior gene or cell therapy 14. Use of systemic immunosuppressant or steroid therapy other than protocol-specified immunosuppression 15. Participation in another therapeutic investigational drug or device study within 3 months or 5 half-lives of the study agent, whichever is longer (unless it can be documented that the patient received placebo) 16. Have an anti-AAV9 antibody titer of >1:40 as determined by the central laboratory. 17. Clinically significant abnormalities in laboratory test results at Screening 18.Have any contraindications for MRI, including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Incidence and severity of TEAEs and SAEs, including clinically significant changes in vital signs, clinical laboratory parameter assessments, 12-lead ECGs, results of abdominal and bone MRIs, physical and neurological examinations, and waist circumference and weight over time.
Secondary endpoints 5
- Change and percent change from baseline in spleen volume (MN)
- Change from baseline in platelet count
- Change from baseline in GCase enzyme activity and protein levels and GluSph levels
- Time from LY3884961 to ERT/SRT discontinuation.
- Time from discontinuation of ERT/SRT to re-initiation of ERT/SRT.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD9609326 · Product
- Active substance
- Adeno-Associated Viral Vector Serotype 9 Expressing Codon-Optimized Human Gba Gene
- Substance synonyms
- LY3884961, PR001A, Adeno-associated viral vector serotype 9 expressing codon-optimized human glucosylceramidase beta gene
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/21/2413
Auxiliary 13
Rapamune 0.5 mg coated tablets
PRD3342089 · Product
- Active substance
- Sirolimus
- Substance synonyms
- SEL-110.36, RAPAMYCIN, NPG-12G, (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-Hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclohentriacontine-1,5,11,28,29(4H,6H,31H)-pentone
- Pharmaceutical form
- COATED TABLET
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L04AA10 — SIROLIMUS
- Marketing authorisation
- EU/1/01/171/013
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10537MIG · Substance
- Active substance
- Sirolimus
- Pharmaceutical form
- COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Rapamune 0.5 mg coated tablets
PRD3342090 · Product
- Active substance
- Sirolimus
- Substance synonyms
- SEL-110.36, RAPAMYCIN, NPG-12G, (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-Hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclohentriacontine-1,5,11,28,29(4H,6H,31H)-pentone
- Pharmaceutical form
- COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- L04AA10 — SIROLIMUS
- Marketing authorisation
- EU/1/01/171/014
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD3342091 · Product
- Active substance
- Sirolimus
- Substance synonyms
- SEL-110.36, RAPAMYCIN, NPG-12G, (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-Hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclohentriacontine-1,5,11,28,29(4H,6H,31H)-pentone
- Pharmaceutical form
- COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- L04AA10 — SIROLIMUS
- Marketing authorisation
- EU/1/01/171/008
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD3342088 · Product
- Active substance
- Sirolimus
- Substance synonyms
- SEL-110.36, RAPAMYCIN, NPG-12G, (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-Hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclohentriacontine-1,5,11,28,29(4H,6H,31H)-pentone
- Pharmaceutical form
- COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- L04AA10 — SIROLIMUS
- Marketing authorisation
- EU/1/01/171/007
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10537MIG · Substance
- Active substance
- Sirolimus
- Pharmaceutical form
- COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10020MIG · Substance
- Active substance
- Prednisone
- Pharmaceutical form
- TABLETS
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Prednisona Cinfa 10 MG Comprimidos
PRD2845105 · Product
- Active substance
- Prednisone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- H02AB — GLUCOCORTICOIDS
- Marketing authorisation
- 75.649
- MA holder
- LABORATORIOS CINFA, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08872MIG · Substance
- Active substance
- Methylprednisolone
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS BOLUS INJECTION/IV INFUSION
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Solu-Medrol 1000 mg por és oldószer oldatos injekcióhoz
PRD453020 · Product
- Active substance
- Methylprednisolone
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS BOLUS INJECTION/IV INFUSION
- Authorisation status
- Authorised
- ATC code
- H02AB04 — METHYLPREDNISOLONE
- Marketing authorisation
- OGYI-T-2245/05
- MA holder
- PFIZER KFT.
- MA country
- Hungary
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Prednisone Mylan Pharma 5 mg compresse
PRD3465897 · Product
- Active substance
- Prednisone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- H02AB — GLUCOCORTICOIDS
- Marketing authorisation
- 043412016
- MA holder
- MYLAN S.P.A.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10020MIG · Substance
- Active substance
- Prednisone
- Pharmaceutical form
- TABLETS
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB25187 · Substance
- Active substance
- Eculizumab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/21/2413
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Prevail Therapeutics Inc.
- Sponsor organisation
- Prevail Therapeutics Inc.
- Address
- 645 Summer Street
- City
- Boston
- Postcode
- 02210-2135
- Country
- United States
Scientific contact point
- Organisation
- Prevail Therapeutics Inc.
- Contact name
- Regulatory Department
Public contact point
- Organisation
- Prevail Therapeutics Inc.
- Contact name
- Regulatory Department
Third parties 15
| Organisation | City, country | Duties |
|---|---|---|
| Clario ORL-000001208
|
Princeton, United States | Other |
| Scout Clinical ORG-100042228
|
Dallas, United States | Other |
| Pharmaceutical Product Development LLC ORG-100016999
|
Highland Heights, United States | Other, Laboratory analysis |
| Centogene GmbH ORG-100043695
|
Rostock, Germany | Laboratory analysis |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Pharma Start LLC ORG-100042396
|
Chicago, United States | Other |
| Sbh Sciences Inc. ORG-100043052
|
Natick, United States | Laboratory analysis |
| PPD Development LP ORG-100011560
|
Wilmington, United States | On site monitoring, Code 10, Code 11, Code 12, Code 2, Code 5, Data management |
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | Other, E-data capture |
| Labcorp Early Development Laboratories Limited ORG-100011365
|
Harrogate, United Kingdom | Laboratory analysis |
| Quipment ORG-100043496
|
Nancy, France | Other |
| PPD International Holdings LLC ORG-100007655
|
Zaventem, Belgium | Other, Laboratory analysis |
| Bioagilytix Labs LLC ORG-100013030
|
Durham, United States | Laboratory analysis |
| Pharmaceutical Product Development LLC ORG-100016999
|
Richmond, United States | Laboratory analysis |
| Kcas LLC ORG-100043073
|
Olathe, United States | Laboratory analysis |
Locations
2 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Temporarily halted | 2 | 1 |
| Spain | Temporarily halted | 4 | 2 |
| Rest of world
Australia, United Kingdom, Brazil, United States
|
— | 9 | — |
Investigational sites
Sphincs GmbH
n/a, Geheimrat-Hummel-Platz 2, 65239, Hochheim Am Main
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2024-04-22 | 2025-03-26 | 2026-04-13 | ||
| Spain | 2023-10-18 | 2023-11-06 | 2026-04-13 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 4 · Art. 38 CTR
Temporary halt TH-95431
- Halt date
- 2025-08-15
- Member states concerned
- Spain
- Publication date
- 2025-08-28
- Reason
- Sponsor decision, Safety related (clinical or pre-clinical results)
- Explanation
- Abnormal imaging finding in one study participant administered LY3884961. Screening in the study will continue, but administration of LY3884961 will be paused pending further evaluation and determination of any potential impact to benefit-risk profile.
- Follow-up measures
- Additional medical evaluation will be conducted to investigate the abnormal imaging finding and any potential impact to benefit-risk profile. All study participants administered LY3884961 will continue to be monitored for safety.
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Temporary halt TH-130663
- Halt date
- 2026-04-13
- Member states concerned
- Germany
- Publication date
- 2026-04-24
- Reason
- Medicinal Product related, Sponsor decision
- Explanation
- Out-of-specification (OOS) finding during routine stability testing. Administration of LY3884961 paused pending completion of the OOS investigation.
- Follow-up measures
- All study participants administered LY3884961 will continue to be monitored for safety per protocol.
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Temporary halt TH-95426
- Halt date
- 2025-08-15
- Member states concerned
- Germany
- Publication date
- 2025-08-28
- Reason
- Sponsor decision, Safety related (clinical or pre-clinical results)
- Explanation
- Abnormal imaging finding in one study participant administered LY3884961. Screening in the study will continue, but administration of LY3884961 will be paused pending further evaluation and determination of any potential impact to benefit-risk profile.
- Follow-up measures
- Additional medical evaluation will be conducted to investigate the abnormal imaging finding and any potential impact to benefit-risk profile. All study participants administered LY3884961 will continue to be monitored for safety.
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Temporary halt TH-130664
- Halt date
- 2026-04-13
- Member states concerned
- Spain
- Publication date
- 2026-04-24
- Reason
- Medicinal Product related, Sponsor decision
- Explanation
- Out-of-specification (OOS) finding during routine stability testing. Administration of LY3884961 paused pending completion of the OOS investigation.
- Follow-up measures
- All study participants administered LY3884961 will continue to be monitored for safety per protocol.
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 48 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Prevail_J3Z-MC-OJAE_2022-500281-10-02_Protocol_Public | 9.0 |
| Protocol (for publication) | D1_Prevail_J3Z-MC-OJAE_Clinical Continuity Guidance_2022-500281-10-02_Public | 2 |
| Protocol (for publication) | D1_Prevail_J3Z-MC-OJAE_Protocol Admin Letter QR161_Public | 7.3 |
| Protocol (for publication) | D1_Prevail_J3Z-MC-OJAE_Protocol Admin Letter QR164_Public | 7.3 |
| Protocol (for publication) | D4_Prevail_J3Z-MC-OJAE_mGD-PROM__ES_Spanish_Public | 1.0 |
| Protocol (for publication) | D4_Prevail_J3Z-MC-OJAE_mGD-PROM_DE_German_Public | 1.0 |
| Protocol (for publication) | D4_Prevail_J3Z-MC-OJAE_Scales and Assessments_All Languages_Public | n/a |
| Protocol (for publication) | Prevail_J3Z-MC-OJAE_CGI-I_Public | 1.0 |
| Protocol (for publication) | Prevail_J3Z-MC-OJAE_CGI-S_Public | 4.0 |
| Protocol (for publication) | Prevail_J3Z-MC-OJAE_Pharmacy_Manual_ForPub | 8.0 |
| Protocol (for publication) | Prevail_J3Z-MC-OJAE_rmGD1-PROM_Public | 1.0 |
| Recruitment arrangements (for publication) | K_J3Z-MC-OJAE_Recruitment-Arrangements-and-ICF-Procedure_ES_ForPub | n/a |
| Recruitment arrangements (for publication) | K1_J3Z-MC-OJAE_Recruitment-Informed-Consent-Procedure_GER_Public | n/a |
| Recruitment arrangements (for publication) | K2_J3Z-MC-OJAE_Doctors-Letter_DEU_German_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_J3Z-MC-OJAE_Gaucher-Disease_SM_Doctors Letter_ES_Spanish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_J3Z-MC-OJAE_Gaucher-Disease_SM_Patients-Letter_ES_Spanish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_J3Z-MC-OJAE_GP-letter_DE_ForPub | 3.0 |
| Recruitment arrangements (for publication) | K2_J3Z-MC-OJAE_GP-Letter_ES_English_Public | 3.0 |
| Recruitment arrangements (for publication) | K2_J3Z-MC-OJAE_Patient-Letter_DEU_German_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_J3Z-MC-OJAE_Proceed-Study-Brochure_ES_Spanish_Public | 3.0 |
| Recruitment arrangements (for publication) | K2_J3Z-MC-OJAE_Study-Brochure_DEU_German_Public | 3 |
| Recruitment arrangements (for publication) | K2_J3Z-MC-OJAE_Visit-Guide_DEU_German_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_J3Z-MC-OJAE_VisitGuide_ES_Spanish_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_J3Z-MC-OJAE_HIP Voluntario Sano_RMN_ ES_Spanish_L_ForPub | 2.0 |
| Subject information and informed consent form (for publication) | L1_J3Z-MC-OJAE_ICF_Biomedical-Research_DE_ForPub | 4.0 |
| Subject information and informed consent form (for publication) | L1_J3Z-MC-OJAE_Main_ICF_DE_ForPub | 13.0 |
| Subject information and informed consent form (for publication) | L1_J3Z-MC-OJAE_Main_ICF_Spain_Spanish_Public | 13.0 |
| Subject information and informed consent form (for publication) | L1_J3Z-MC-OJAE_Optional_Future-Research_ICF_DE_ForPub | 4.0 |
| Subject information and informed consent form (for publication) | L1_J3Z-MC-OJAE_Pregnant-and-New-Born-ICF_ES_Spanish_ForPub | 2.0 |
| Subject information and informed consent form (for publication) | L1_J3Z-MC-OJAE_Pregnant-Female-Newborn-ICF_DE_ForPub | 2.0 |
| Subject information and informed consent form (for publication) | L1_J3Z-MC-OJAE_SC-ICF_DE_ForPub | 1.3 |
| Subject information and informed consent form (for publication) | L1_J3Z-MC-OJAE_Scout_HIP_ES_Spanish _ForPub | 1.3 |
| Subject information and informed consent form (for publication) | L1_J3Z-MC-OJAE_Scout-Clinical-Brochure_ES_Spanish_ForPub | 1.0 |
| Subject information and informed consent form (for publication) | L1_J3Z-MC-OJAE_Scout-Clinical-Card-Guideline_ES_Spanish_ForPub | 1.0 |
| Subject information and informed consent form (for publication) | L1_J3Z-MC-OJAE_Scout-Clinical-email_ES_Spanish_ForPub | 1.0 |
| Subject information and informed consent form (for publication) | L1_J3Z-MC-OJAE_Scout-Clinical-Prepaid-Card_ES_Spanish_ForPub | n/a |
| Subject information and informed consent form (for publication) | L1_J3Z-MC-OJAE_Supplemental-Future-Biomedical-Research_ICF_Spain_Spanish_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_J3Z-MC-OJAE_Volunteer-MRI-ICF_DE_ForPub | 2.0 |
| Subject information and informed consent form (for publication) | L2_J3Z-MC-OJAE_S485-SC-PFD-Email-Comm-ERR-TR_DE_ForPub | 1.0 |
| Subject information and informed consent form (for publication) | L2_J3Z-MC-OJAE_S485-Scout-Pass-EUR_DE_ForPub | N/A |
| Subject information and informed consent form (for publication) | L2_J3Z-MC-OJAE_SC-PFD-ScoutPass-Reloadable-EUR_DE_ForPub | 1.0 |
| Subject information and informed consent form (for publication) | L2_J3Z-MC-OJAE_SC-PFD-Study-Brochure_DE_ForPub | 1.0 |
| Synopsis of the protocol (for publication) | D1_Prevail_J3Z-MC-OJAE_Lay Summary of Protocol_2022-500281-10-02_ES_Public | 3.0 |
| Synopsis of the protocol (for publication) | D1_Prevail_J3Z-MC-OJAE_Lay Summary of Protocol_DE_2022-500281-10-02_Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_Prevail_J3Z-MC-OJAE_Lay Summary of Protocoll_2022-500281-10-02_EN_Public | 3.0 |
| Synopsis of the protocol (for publication) | D1_Prevail_J3Z-MC-OJAE_Protocol Synopsis_2022-500281-10-02_Public | 9.0 |
| Synopsis of the protocol (for publication) | D1_Prevail_J3Z-MC-OJAE_Protocol Synopsis_DE_2022-500281-10-02_Public | 8.1 |
| Synopsis of the protocol (for publication) | D1_Prevail_J3Z-MC-OJAE_Protocolo Sinopsis_ES_2022-500281-10-02_Public | 9.0 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-12 | Spain | Acceptable 2023-09-04
|
2023-09-05 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-11-13 | Acceptable 2023-09-04
|
2023-11-13 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-07 | Spain | Acceptable 2024-02-05
|
2024-02-08 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-02-14 | Spain | Acceptable 2024-05-07
|
2024-05-07 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-06-07 | Spain | Acceptable 2024-08-27
|
2024-08-27 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-01-03 | Acceptable | 2025-02-07 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-01-03 | Spain | Acceptable | 2025-02-05 |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-06-09 | Spain | Acceptable 2025-07-21
|
2025-07-24 |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-09-05 | Acceptable | 2025-09-11 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-12-11 | Spain | Acceptable 2026-02-05
|
2026-02-06 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-03-10 | Spain | Acceptable 2026-02-05
|
2026-03-10 |