RECRUITING

Phase 2 Study to Assess the Safety, PK, and PD in SBS-IF Subjects

Talk to us

Conditions

Short Bowel Syndrome

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a randomized, double-blind, placebo-controlled, proof-of-concept (PoC), Phase 2 study to assess the safety, PK, and PD of SC administration of HM15912(sonefpeglutide) in adult subjects with SBS-associated intestinal failure (SBS-IF).

Official Title

A Multicenter, Proof-of-concept, Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM15912 (Sonefpeglutide) in Adult Subjects With Short Bowel Syndrome-associated Intestinal Failure (SBS-IF)

Quick Facts

Study Start:2022-03-03
Study Completion:2028-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04775706

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Men or women, aged 18 years of age or older with SBS resulting in intestinal failure at the time of signing the informed consent form (ICF) (or country's legal age of majority if the legal age is \<18 years)
  2. 2. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
  3. 3. Diagnosis of SBS with the latest intestinal resection being at least 6 months prior to Screening and considered stable regarding the PN/IV need. No restorative surgery planned in the study period.
  1. 1. Any history of colon cancer.
  2. 2. History of any other cancers (except margin-free resected cutaneous basal or squamous cell carcinoma or adequately treated in situ cervical cancer) unless disease-free for at least 5 years
  3. 3. History of alcohol or drug abuse (within 1 year of screening)

Contacts and Locations

Study Contact

Wooyoung Hong
CONTACT
+82 2 410 9238
wooyoung.hong@hanmi.co.kr

Study Locations (Sites)

University of Illinois Hospital & Health Sciences System (UI Health)
Chicago, Illinois, 60612
United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115
United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: Hanmi Pharmaceutical Company Limited

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-03
Study Completion Date2028-05

Study Record Updates

Study Start Date2022-03-03
Study Completion Date2028-05

Terms related to this study

Additional Relevant MeSH Terms

  • Short Bowel Syndrome