Role of Pancreatic Enzyme Replacement Therapy (PERT) (Creon®) in Pancreatic Exocrine Insufficiency (PEI) due to gastrectomy.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

BGP Products Operations GmbH

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

6 Mar 2025 → ongoing

Decision date (initial)

2025-01-21

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

BGP Products Operations GmbH

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To evaluate the effect of Creon as PERT on the nutritional status of the patient with PEI developed post-gastrectomy.

Secondary objectives 1

1. To evaluate incidence of PEI post-gastrectomy and the effect of Creon as PERT on body weight, gastrointestinal symptoms of PEI, nutritional status, and quality of life.

Conditions and MedDRA coding

Male and female patients aged ≥ 18 to ≤ 80 after total gastrectomy.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Male and female participants of any ethnic origin.
2. Participants between 18 to 80 (inclusive of both) years of age.
3. Willing to comply with the requirements of the study protocol.
4. Provide written informed consent.
5. Have previously undergone total gastrectomy.
6. Participant with pancreatic exocrine insufficiency as evidenced by clinical symptoms and confirmed by fecal elastase test.
7. Participant should not be receiving chemotherapy/radiotherapy during the last week prior to enrollment into the treatment phase.
8. Participant should not have exposure to any other investigational product within the last three months prior to enrollment into the treatment phase.

Exclusion criteria 11

1. On treatment with medications like somatostatin or aprotinin that directly influence pancreatic exocrine function.
2. Previously taken Creon or any other PERT product within last 1 week prior to Day 1 of pretreatment phase.
3. Evidence of severe cardiovascular, respiratory, urogenital, gastrointestinal, hepatic, hematological, immunological, head, ears, eyes, nose, throat (HEENT), dermatological, connective tissue, musculoskeletal, metabolic (other than CF), nutritional, endocrine, neurologic, psychiatric disease; allergy, major surgery, or any other relevant disease as revealed by history or physical examination which might limit participation in or completion of the study.
4. History of allergic reaction or hypersensitivity to pancreatin or excipients of Creon.
5. Positive β-human chorionic gonadotropin (hCG) pregnancy test, established pregnancy, or breast-feeding at Day 1 of pretreatment phase. - Women of childbearing potential not using at least one effective method of contraception (preferably one whose effectiveness is not dependent on the user, such as an intrauterine device or implant).
6. Clinically relevant acute infections, febrile disease or any acute condition (illness) two weeks prior to Day 1 of pretreatment phase, as judged by the investigator.
7. History of alcohol or drug abuse within the last 2 years.
8. Lack of willingness to have personal study-related data collected, archived, or transmitted according to protocol.
9. Lack of willingness or inability to co-operate during the conduct of the study, adequately.
10. Anticipated non-availability for study visits/procedures.
11. Vulnerable subjects (such as persons kept in detention).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of patients on stable dose of Creon, in whom there is no deterioration of nutritional status (as measured by no loss of body weight from baseline Visit).

Secondary endpoints 7

1. Change in bodyweight from baseline
2. Percentage of patients who develop symptomatic pancreatic exocrine insufficiency after gastrectomy.
3. Symptoms of pancreatic exocrine insufficiency measured (as recorded in subject diaries)
4. Nutritional parameters
5. Gastrointestinal Quality of life index (GIQLI) questionnaire
6. Treatment Emergent Adverse Events (TEAEs)
7. Change in vital signs

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

BGP Products Operations GmbH

Sponsor organisation

BGP Products Operations GmbH

Address

Turmstrasse 24

City

Steinhausen

Postcode

6312

Country

Switzerland

Scientific contact point

Organisation

BGP Products Operations GmbH

Contact name

EUClinicalTrials@viatris

Public contact point

Organisation

BGP Products Operations GmbH

Contact name

EUClinicalTrials@viatris

Third parties 7

Locations

3 EU/EEA countries · 19 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 39 files

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

Application history

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