Double-blind, Randomised Study of A3384 in BAM/BAD

A Phase II, Placebo-controlled, Multi-centre, Dose-finding Efficacy and Safety Study of a Range of Doses of A3384 in Patients With Bile Acid Malabsorption (BAM)/Bile Acid Diarrhoea (BAD)

The purpose of this trial is to determine the efficacy and safety of A3384 administered to patients with Bile Acid Malabsorption (BAM)/Bile Acid Diarrhoea (BAD).

Study Overview

• Status: Completed
• Conditions: Bile Acid Malabsorption
• Intervention / Treatment: Drug: A3384

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2

Contacts and Locations

Study Locations

• Sweden
  • Göteborg, Sweden
    • Sahlgrenska Academy
  • Skövde, Sweden
    • Kärnsjukhuset
• United Kingdom
  • London, United Kingdom, W12 0HS
    • Hammersmith Hospital, Imperial College Healthcare NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient meets protocol specified criteria for Bile Acid Malabsorption/Bile Acid Diarrhoea
• Patient has successfully completed study requirements with no clinically relevant findings for physical exam, ECG, laboratory tests as applicable

Exclusion Criteria:

• Medical history or medical condition that would not make the patient a good candidate for the study or limit the patient´s ability to complete the study
• Patient needs medications prohibited as specified in the protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A3384 Low dose; Administered twice daily for the duration of the study	Drug: A3384
Experimental: A3384 High dose; Administered twice daily for the duration of the study	Drug: A3384
Placebo Comparator: Placebo; Administered twice daily for the duration of the study	Drug: A3384

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary efficacy objective of this study is to demonstrate the efficacy of different daily doses of A3384 as determined by the # of bowel movements (BMs).	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary efficacy objectives of this study are to demonstrate the efficacy of different daily doses on other BM parameters and BAM/BAD symptoms	Change from Baseline in average severity of diarrhoea during the second treatment week (last 7 days of reporting).; Change from Baseline in average severity of abdominal discomfort during the second treatment week (last 7 days of reporting).; Change from Baseline in average severity of abdominal bloating during the second treatment week (last 7 days of reporting).; Change from Baseline in average BSFS during the second treatment week (last 7 days of reporting)	Baseline and 2 weeks

Collaborators and Investigators

• Sponsor: Albireo
• Investigators: Study Director: Ipsen Medical Director, Ipsen

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: March 3, 2014
• First Submitted That Met QC Criteria: March 4, 2014
• First Posted (Estimated): March 5, 2014

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes
• Other Study ID Numbers: A3384-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications.

Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

• IPD Sharing Time Frame: Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
• IPD Sharing Access Criteria: Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).