Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
202
Countries
1
Sites
6
Renal transplantation
To compare the degree of HLA sensitization at 2 years in patients with late renal graft failure (> 3 months) when receiving reduced immunosuppressant treatment versus stopping immunosuppression at 6 months.
Key facts
- Sponsor
- Vall D'hebron Institut De Recerca
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]
- Trial duration
- 22 Jan 2024 → ongoing
- Decision date (initial)
- 2023-11-10
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Instituto de Salud Carlos III
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety, Efficacy
To compare the degree of HLA sensitization at 2 years in patients with late renal graft failure (> 3 months) when receiving reduced immunosuppressant treatment versus stopping immunosuppression at 6 months.
Secondary objectives 1
- (1) To compare the following outcomes at 2 years in patients with late renal graft failure (> 3 months) when receiving reduced immunosuppressant treatment versus stopping immunosuppression at 6 months: •Mortality for any reason • Days of hospitalization for any reason • Percentage of patients effectively relisted during follow-up • Percentage of patients transplanted • Percentage of patients delisted for any reason • Incidence of infection • Incidence of cardiovascular events • Incidence of cancer • Incidence of graft-intolerance syndrome requiring graft nephrectomy or percutaneous embolization of the non-functioning graft • Erythropoietin resistance index • Residual renal function • Number of circulating memory B-cells. (2) To compare the incidence of adverse events in both treatment arms.
Conditions and MedDRA coding
Renal transplantation
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | PREVSENSI Phase IV clinical trial, prospective, randomized, multicentric, open-labeled with parallel groups. Patients will beallocated to the control or investigation arm.
|
Randomised Controlled | None | Control arm: - Patients will continue to take CNI the first 3 months of the study (Day 1 to Day 90) to the same whole blood levels that they were taking before enrolling in the study (in general, 4-7 ng/ml tacrolimus or 50-100 ng/ml cyclosporine). - CNI dose (tacrolimus or cyclosporine) will be reduced to one-half on Day 90 (month 3 visit) and completely withdrawn on Day 180 (month 6 visit). Investigation arm: - Patients will continue to take CNI the first 3 months of the study (Day 1 to Day 90) to the same whole blood levels that they were taking before enrolling in the study (in general 4-7 ng ng/ml for tacrolimus or 50-100 ng/ml for cyclosporine). - CNI dose (tacrolimus or cyclosporine) will be adjusted to maintain low tacrolimus (3-6 ng/ml) or cyclosporine (25-75 ng/ml) whole blood trough levels from Day 90 (month 3) to Day 720 (month 24 or End of Study). |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Patients eligible for the study must comply with all of the following at randomization; Patient must be able to understand and provide written informed consent; Patients older than 18 years who had received at least one previous renal transplant; Patients with a retained kidney graft failed for any reason which survived at least 3 months; Patients on dialysis, either hemodialysis or peritoneal dialysis. Patients can be on dialysis for a maximum of 6 months at the time of randomization, as long as the patients have taken an uninterrupted immunosuppressive regimen of calcineurin inhibitors (tacrolimus or cyclosporine) and steroids since dialysis was restarted. This period may be extended up to 12 months if the immunosuppressive regimen has remained stable and has not been reduced by more than 50%.; Patients already relisted or candidates to relist to deceased donor kidney transplantation according to the treating physician criteria; Patients taking immunosuppressants tacrolimus or cyclosporine; cPRA at the time of randomization ≤ 90%.
Exclusion criteria 1
- The following patients will be excluded from the study: Patients who have received another solid organ transplantation (liver, lung, heart or pancreas); Patients waiting for a living related / unrelated kidney transplant; Graft survival of the failed graft lower than 3 months; Patients in dialysis more than 6 months at the time of randomization, unless they have maintained a stable immunosuppressive regimen (calcineurin inhibitors and steroids, without reductions greater than 50%) since dialysis was restarted; in that case, patients will be excluded if they have been on dialysis for more than 12 months.; Patients not accomplishing criteria to relist in the transplantation list according to the treating physician criteria; Pregnant women; • Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study; Patients should use one of the acceptable birth control measures recommended in the document “Recommendations related to contraception and pregnancy testing in clinical trials” published by the Clinical Trials Facilitation and Coordination Group (CTFG) (version 1.1, published 21/09/2020). Recommended birth control measures include oral, injected or implanted hormonal contraceptive, barrier methods (condom or diaphragm with spermicide), intrauterine device, surgical sterilization, transdermal delivery, or sexual abstinence. If sexually active, the subject must have been using one of the accepted birth control methods at least one month prior to study entry
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary variable will be the difference between the two treatment arms in the degree of HLA sensitization at 2-years measured as cPRA (%).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 22
PRD328850 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 14400 mg milligram(s)
- Max treatment duration
- 720 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- 63.189
- MA holder
- ASTELLAS PHARMA S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD334469 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 14400 mg milligram(s)
- Max treatment duration
- 720 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- 61.005
- MA holder
- ASTELLAS PHARMA S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD334470 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 14400 mg milligram(s)
- Max treatment duration
- 720 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- 61.006
- MA holder
- ASTELLAS PHARMA S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Envarsus 4 mg prolonged-release tablets
PRD1609569 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE TABLET
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 14400 mg milligram(s)
- Max treatment duration
- 720 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/14/935/007
- MA holder
- CHIESI FARMACEUTICI S.P.A.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Envarsus 1 mg prolonged-release tablets
PRD1609561 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE TABLET
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 14400 mg milligram(s)
- Max treatment duration
- 720 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/14/935/004
- MA holder
- CHIESI FARMACEUTICI S.P.A.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Envarsus 0.75 mg prolonged-release tablets
PRD1609514 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE TABLET
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 14400 mg milligram(s)
- Max treatment duration
- 720 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/14/935/001
- MA holder
- CHIESI FARMACEUTICI S.P.A.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Advagraf 1 mg prolonged-release hard capsules
PRD328675 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 14400 mg milligram(s)
- Max treatment duration
- 720 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/07/387/003
- MA holder
- ASTELLAS PHARMA EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Advagraf 3 mg prolonged-release hard capsules
PRD324632 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 14400 mg milligram(s)
- Max treatment duration
- 720 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/07/387/011
- MA holder
- ASTELLAS PHARMA EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Advagraf 5 mg prolonged-release hard capsules
PRD324633 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 14400 mg milligram(s)
- Max treatment duration
- 720 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/07/387/007
- MA holder
- ASTELLAS PHARMA EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Advagraf 0.5 mg prolonged-release hard capsules
PRD330537 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 14400 mg milligram(s)
- Max treatment duration
- 720 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/07/387/001
- MA holder
- ASTELLAS PHARMA EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sandimmun Neoral 50 mg cápsulas blandas
PRD2548632 · Product
- Active substance
- Ciclosporin
- Pharmaceutical form
- CAPSULE, SOFT
- Route of administration
- ORAL
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 360000 mg milligram(s)
- Max treatment duration
- 720 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AD01 — -
- Marketing authorisation
- 60.318
- MA holder
- NOVARTIS FARMACÉUTICA S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sandimmun Neoral 25 mg cápsulas blandas
PRD2548631 · Product
- Active substance
- Ciclosporin
- Pharmaceutical form
- CAPSULE, SOFT
- Route of administration
- ORAL
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 360000 mg milligram(s)
- Max treatment duration
- 720 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AD01 — -
- Marketing authorisation
- 60.319
- MA holder
- NOVARTIS FARMACÉUTICA S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sandimmun Neoral 100 mg cápsulas blandas
PRD2548629 · Product
- Active substance
- Ciclosporin
- Pharmaceutical form
- CAPSULE, SOFT
- Route of administration
- ORAL
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 360000 mg milligram(s)
- Max treatment duration
- 720 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AD01 — -
- Marketing authorisation
- 60.320
- MA holder
- NOVARTIS FARMACÉUTICA S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Conferoport 3 mg cápsulas duras de liberación prolongada EFG
PRD7711705 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 14400 mg milligram(s)
- Max treatment duration
- 720 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- 84631
- MA holder
- SANDOZ FARMACÉUTICA, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Conferoport 2 mg cápsulas duras de liberación prolongada
PRD7711698 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 14400 mg milligram(s)
- Max treatment duration
- 720 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- 84630
- MA holder
- SANDOZ FARMACÉUTICA, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Conferoport 0,5 mg cápsulas duras de liberación prolongada EFG
PRD7711696 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 14400 mg milligram(s)
- Max treatment duration
- 720 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- 84607
- MA holder
- SANDOZ FARMACÉUTICA, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Conferoport 1 mg cápsulas duras de liberación prolongada EFG
PRD7711697 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 14400 mg milligram(s)
- Max treatment duration
- 720 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- 84629
- MA holder
- SANDOZ FARMACÉUTICA, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Conferoport 5 mg cápsulas duras de liberación prolongada EFG
PRD7711706 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 14400 mg milligram(s)
- Max treatment duration
- 720 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- 84632
- MA holder
- SANDOZ FARMACÉUTICA, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Adoport 0,5 mg cápsulas duras EFG
PRD795761 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 14400 mg milligram(s)
- Max treatment duration
- 720 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- 71673
- MA holder
- SANDOZ FARMACÉUTICA, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Adoport 1 mg cápsulas duras EFG
PRD796006 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 14400 mg milligram(s)
- Max treatment duration
- 720 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- 71674
- MA holder
- SANDOZ FARMACÉUTICA, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD2419821 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 14400 mg milligram(s)
- Max treatment duration
- 720 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- 79456
- MA holder
- SANDOZ FARMACÉUTICA, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Adoport 5 mg cápsulas duras EFG
PRD795764 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 14400 mg milligram(s)
- Max treatment duration
- 720 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- 71675
- MA holder
- SANDOZ FARMACÉUTICA, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Vall D'hebron Institut De Recerca
- Sponsor organisation
- Vall D'hebron Institut De Recerca
- Address
- Passeig De La Vall D'hebron 119-129
- City
- Barcelona
- Postcode
- 08035
- Country
- Spain
Scientific contact point
- Organisation
- Vall D'hebron Institut De Recerca
- Contact name
- Laura Cascales
Public contact point
- Organisation
- Vall D'hebron Institut De Recerca
- Contact name
- Laura Cascales
Locations
1 EU/EEA country · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 202 | 6 |
| Rest of world | — | 0 | — |
Investigational sites
Fundacio Puigvert
Nephrology, Calle De Cartagena 340-350, 08025, Barcelona
Bellvitge University Hospital
Nephrology, Carrer De La Feixa Llarga Sn, 08907, L'hospitalet De Llobregat
Hospital Clinic De Barcelona
Nephrology, Calle Villarroel 170, 08036, Barcelona
Hospital Del Mar
Nephrology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Germans Trias I Pujol
Nephrology, Carretera Canyet 1a Planta, 08916, Badalona
Hospital Universitari Vall D Hebron
Nephrology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
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 |
|---|---|---|---|---|---|
| Spain | 2024-01-22 | 2024-01-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 27 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2023-506879-98-00 | 1 |
| Protocol (for publication) | D1_Protocol_EU CT 2023-506879-98-00_cambios | 4.0 |
| Protocol (for publication) | D1_Protocol_EU CT 2023-506879-98-00_limpio | 4.0 |
| Protocol (for publication) | D1_Protocol_SM1_2023-506879-98-00 | 2.0 |
| Protocol (for publication) | D1_SM2_Protocol_2023-506879-98-00 | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K2_Satalite sites process | 1 |
| Recruitment arrangements (for publication) | K2_SM2_Satalite sites process | 2.0 |
| Recruitment arrangements (for publication) | K2_SM2_Satalite sites process_cambios | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adults_ limpia | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adults_cambios | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_patients | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_patients_SM1 | 2.0 |
| Subject information and informed consent form (for publication) | L1_SM2_SIS and ICF_patients | 2.1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Adoport | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Advagraf | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Conferoport | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Envarsus | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Prograf | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Sandimmun Neoral | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis EU CT 2023-506879-98-00 cambios | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis EU CT 2023-506879-98-00_limpia | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis Spanish EU CT 2023-506879-98-00 limpia | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis Spanish EU CT 2023-506879-98-00_cambios | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ESP_2023-506879-98-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ESP_SM1_2023-506879-98-00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_SM2_Protocol synopsis_ESP_2023-506879-98-00 | 3.0 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-03 | Spain | Acceptable 2023-11-10
|
2023-11-10 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-20 | Spain | Acceptable 2024-04-26
|
2024-04-26 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-08-06 | Spain | Acceptable 2024-09-25
|
2024-09-25 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-01-15 | Spain | Acceptable 2026-03-02
|
2026-03-06 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-25 | Spain | Acceptable 2026-03-02
|
2026-03-25 |