Transfer of prednisolone into human breast milk and plasma of breastfeeding children

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Uppsala Universitet

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

5 Mar 2024 → 31 Dec 2025

Decision date (initial)

2024-03-05

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic

The primary objective is to determine the concentration of prednisolone in the plasma of breast-fed infants of lactating women treated with prednisolone to reduce inflammation in a variety of conditions.

Secondary objectives 2

1. To determine concentration of prednisolone/prednisone in the breast milk and maternal plasma and the milk-to-plasma ratio in the mothers and to calculate the average daily infant dose (ADID) and relative infant dose (RID). to evaluate the cortisol levels in the infants.
2. To evaluate the cortisol levels in the infants.

Conditions and MedDRA coding

Reumatoid Arthritis, SLE, myositis, psoriatric arthritis, inflammatory bowel disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Breastfeeding women treated with prednisolone with doses up to 50mg/day for any condition and her child.
2. Only women of 18 years of age and older will be asked for participation.
3. Signed Informed consent form from the woman that participates in the study and the father of the child.

Exclusion criteria 3

1. Woman not able to read and communicate in Swedish or English.
2. Women with infant born prior to 37 weeks gestation (premature).
3. Women with multiple births.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is the concentration of prednisolone in the breastfeeding child’s plasma 2 hr after feeding an infant breast milk, with the feeding taking place at 1 hr following maternal dose intake.

Secondary endpoints 2

1. Concentration of prednisolone and prednisone in breast milk at 1h after maternal dose intake and the maternal plasma concentration of prednisolone and prednisone at 1h after prednisolone intake.
2. Concentration of cortisol in the infant blood at same timepoint blood is drawn for PK measurement.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Uppsala Universitet

Sponsor organisation

Uppsala Universitet

Address

P. O. Box 256

City

Uppsala

Postcode

751 05

Country

Sweden

Scientific contact point

Organisation

Uppsala Universitet

Contact name

Mats Hansson

Public contact point

Organisation

Uppsala Universitet

Contact name

Mats Hansson

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 3 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications