Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
35
Countries
1
Sites
2
pediatric and adult patients undergoing HSC allograft procedures with Thymoglobulin® packaging
characterize the pharmacokinetics (PK) of anti-lymphocyte serum (SAL), Thymoglobulin® in patients involved in a HSC transplantation procedure
Key facts
- Sponsor
- Hospices Civils De Lyon
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 17 Jul 2023 → 26 Nov 2025
- Decision date (initial)
- 2023-04-13
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Hospices Civils de Lyon
External identifiers
- EU CT number
- 2022-501594-39-00
- ClinicalTrials.gov
- NCT05743400
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic
characterize the pharmacokinetics (PK) of anti-lymphocyte serum (SAL), Thymoglobulin® in patients involved in a HSC transplantation procedure
Secondary objectives 2
- evaluate the impact of covariates on the PK variability of SAL
- Assessing the inter-individual PK variability of SAL
Conditions and MedDRA coding
pediatric and adult patients undergoing HSC allograft procedures with Thymoglobulin® packaging
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10063581 | Stem cell transplant | 100000004865 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Thymoglobulin prospective, non-comparative, single-center, multi-site study conducted in two hospitals in France
|
Not Applicable | None | thymoglobulin: 5 to 20 mg/kg depending on the indication, the type of transplant, according to the established protocols of each center. The treatment lasts from 2 to 5 days. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Patient receiving Thymoglobulin therapy as part of a first HSC allograft
- Age ≥ 2 years
- Lansky or Karnosky score ≥ 50%.
- Enrolled in a social security plan
- Patient 18 years of age or older informed and consenting to participate in the study or minor patient whose parents/guardians have been informed and have given consent for the minor patient's participation in the study
- Patients of childbearing potential must have an effective method of contraception throughout the study (a pregnancy test will also be performed at inclusion). Examples of contraceptive methods with a failure rate of <1% per year include bilateral tubal ligation, male sterilisation, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices and copper intrauterine devices.
Exclusion criteria 7
- Patient having received serotherapy (Thymoglobulin® or other) within 3 months before this HSC allograft
- Patient receiving another serotherapy during conditioning (Campath®)
- Patients with uncontrolled acute or chronic infections for which any form of immunosuppression would be contraindicated
- Known hypersensitivity to Thymoglobulin®
- Pregnant or lactating women
- Patient participating simultaneously in another study of an investigational drug (no exclusion period)
- Patient under legal protection or deprived of liberty
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Measurement of plasma SAL exposure (mean AUC and standard deviation in the study population), calculated using population PK methodology
Secondary endpoints 2
- objective function value (OFV)
- Coefficient of variation of the AUC
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
THYMOGLOBULINE 5 mg/ml, poudre pour solution pour perfusion
PRD440932 · Product
- Active substance
- Rabbit Anti-Human Thymocyte Immunoglobulin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 5 mg/kg milligram(s)/kilogram
- Max total dose
- 20 mg/kg milligram(s)/kilogram
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AA04 — ANTITHYMOCYTE IMMUNOGLOBULIN (RABBIT)
- Marketing authorisation
- 34009 570 281 8 3
- MA holder
- GENZYME EUROPE B.V.
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hospices Civils De Lyon
- Sponsor organisation
- Hospices Civils De Lyon
- Address
- 3 Quai Des Celestins, Bp 2251 Bp 2251
- City
- Lyon Cedex 02
- Postcode
- 69229
- Country
- France
Scientific contact point
- Organisation
- Hospices Civils De Lyon
- Contact name
- Dr Michael PHILIPPE
Public contact point
- Organisation
- Hospices Civils De Lyon
- Contact name
- Dr Michael PHILIPPE
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 35 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Hospices Civils De Lyon
Hématologie clinique, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Hospices Civils De Lyon
PEDIATRIC HEMATOLOGY, 1 Place Professeur Joseph Renaut, 69008, Lyon
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 |
|---|---|---|---|---|---|
| France | 2023-07-17 | 2025-11-26 | 2023-09-25 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol 2022-501594-39-00 | 3 |
| Recruitment arrangements (for publication) | Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | SIS and ICF 13-17 yr | 2 |
| Subject information and informed consent form (for publication) | SIS and ICF 2-8 yr | 1 |
| Subject information and informed consent form (for publication) | SIS and ICF 6-8 yr | 2 |
| Subject information and informed consent form (for publication) | SIS and ICF 9-12 yr | 2 |
| Subject information and informed consent form (for publication) | SIS and ICF Participant | 2 |
| Subject information and informed consent form (for publication) | SIS and ICF Patient mineur devenant majeur | 2 |
| Subject information and informed consent form (for publication) | SIS and ICF Titulaires autorite parentale | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Thymoglobulin | 1 |
| Synopsis of the protocol (for publication) | Protocol synopsis_FR 2022-501594-39-00 | 3 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-01-25 | France | Acceptable 2023-04-12
|
2023-04-13 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-25 | France | Acceptable 2023-04-12
|
2025-02-25 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-09-05 | France | Acceptable 2023-04-12
|
2025-09-05 |