Human glucagon-like peptide-2 analogue linked to a human immunoglobulin Fc fragment for Short bowel syndrome-associated intestinal failure (SBS-IF)

Inclusion criteria

• {"criterion_text":"- Men or women aged 18 years or older with confirmed diagnosis of SBS.\n- Had their most recent bowel surgery at least 6 months before joining the study.\n- Subjects must either have no growth of cancer cells in their large intestine or have had any growths removed during a bowel examination within 6 months before joining the study.\n- Subjects must have an opening on their abdomen, commonly called stoma, created by an operation that connects their small intestine to the outside of their body."}

Exclusion criteria

• {"criterion_text":"- History of colon cancer, or any other current or prior medical conditions that would make it difficult to participate in the study.\n- History of alcohol or drug abuse\n- Have a body weight >100 kg and repeated blood pressure measurements > 140 mm Hg."}

Primary endpoints

• {"endpoint_text":"- Primary endpoints to assessment of safety and tolerability of HM15912 after multiple subcutaneous (SC) doses for 24 weeks: • Incidence of adverse events (AEs) • Incidence of injection site reactions • Incidence of clinical laboratory abnormalities • Clinically significant findings on physical examination • Changes from baseline in vital signs and 12-lead electrocardiogram (ECG) parameters","definition_or_measurement_approach":"Assessment over 24 weeks by recording incidence of adverse events, incidence of injection site reactions, incidence of clinical laboratory abnormalities, clinically significant findings on physical examination, and changes from baseline in vital signs and 12-lead ECG parameters."}
• {"endpoint_text":"- Primary endpoints to assessment of the pharmacokinetic (PK) profile of HM15912: • Maximum serum concentration (Cmax) • Time to maximum serum concentration (tmax) • Elimination half-life (t1/2) • Volume of distribution (Vd/F) • Clearance (CL/F) • Area under the concentration-time curve from time zero to the last observable concentration (AUClast), AUC from time zero over the dosing interval at the 1st and 6th dosing, respectively (AUCtau and AUCtau,ss), and AUC extrapolated to infinity","definition_or_measurement_approach":"PK parameters measured from serum concentration–time sampling: estimation of Cmax, tmax, t1/2, Vd/F, CL/F, AUClast, AUCtau, AUCtau,ss and AUC0-∞ derived from concentration–time data (including specified sampling at 1st and 6th dosing)."}

Secondary endpoints

• {"endpoint_text":"- Change in weekly parenteral nutrition/intravenous fluid (PN/IV) volume from baseline to Week 25 Note: The baseline PN/IV volume (L/week) is the average of actual PN/IV volume received during the last 2 weeks of the Stabilization period.","definition_or_measurement_approach":"Change measured as difference in weekly PN/IV volume (L/week) from baseline (baseline defined as average volume during last 2 weeks of Stabilization period) to Week 25."}

Belgium

Earliest CTIS Part Ii Submission Date

25-06-2024

Latest Decision Or Authorization Date

06-08-2024

Processing Time Days

42

Number Of Sites

1

Number Of Participants

2

France

Earliest CTIS Part Ii Submission Date

25-06-2024

Latest Decision Or Authorization Date

02-09-2024

Processing Time Days

69

Number Of Sites

4

Number Of Participants

2

Denmark

Earliest CTIS Part Ii Submission Date

25-06-2024

Latest Decision Or Authorization Date

05-08-2024

Processing Time Days

41

Number Of Sites

2

Number Of Participants

3

Poland

Earliest CTIS Part Ii Submission Date

25-06-2024

Latest Decision Or Authorization Date

09-08-2024

Processing Time Days

45

Number Of Sites

3

Number Of Participants

3

Germany

Earliest CTIS Part Ii Submission Date

25-06-2024

Latest Decision Or Authorization Date

08-08-2024

Processing Time Days

44

Number Of Sites

2

Number Of Participants

3

Primary sponsor

Full Name

Hanmi Pharm. Co. Ltd.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Korea, Republic of

Contract research organisations

Name

Parexel International (IRL) Limited

Responsibilities

Clinical Trial Supply and Logistics; other sponsor duties (codes 1,2,3,6,7,8,9,10,11,12 listed in record)

Name

Perceptive Eclinical Limited

Responsibilities

Interactive response technology / eClinical services (code 3 listed); contact: XLT153IRTstudyteam@calyx.ai

Name

Medical Research Network Limited

Responsibilities

Home Trial Support, Integrated Trial Services, Site Network, MRN Technologies

Name

Fortrea Inc.

Responsibilities

Exit interviews, qualitative analysis, final report, site trainings oversight

Name

Eresearchtechnology Inc.

Responsibilities

ECG central reading; eDiary and eCOA

Third parties

• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"Codes: 1,10,11,12,15 (Clinical Trial Supply and Logistics),2,3,6,7,8,9; contact: clinicaltrial.enquiries@parexel.com","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Medical Research Network Limited","duties_or_roles":"Code 15: Home Trial Support, Integrated Trial Services, Site Network, MRN Technologies; contact: sf4459@themrn.co.uk","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"Code 15: Routine clinical pathology testing, clinical chemistry, clinical haematology, serology/endocrinology; contact: contact@q2labsolutions.com","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Code 15: English-language exit interviews; Qual. Analysis; Final report; Site Trainings; LTG Ass. oversight; contact: submissions@fortrea.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Biologics Development Services LLC","duties_or_roles":"Code 15: PK and immunogenicity analysis; contact: info@immunologixlabs.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Code 15: ECG central reading; eDiary and eCOA; contact: customercare@clario.com","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Perceptive Eclinical Limited","duties_or_roles":"Code 3 (unspecified in record); contact: XLT153IRTstudyteam@calyx.ai","organisation_type":"Pharmaceutical company"}