Bile Acid MalabsorptionPhase 2NCT02078856
Double-blind, Randomised Study of A3384 in BAM/BAD
A Phase 2 study testing A3384 in people with Bile Acid Malabsorption, run by Albireo at 3 sites in 2 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bile Acid Malabsorption
- What is being tested?
- A3384
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Mar 2014to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United Kingdom1 site
Hammersmith Hospital, Imperial College Healthcare NHS Trust
London, W12 0HS
About this study
Official title: 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).
- Conditions
- Bile Acid Malabsorption
- Being tested
- A3384
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A3384Drug
| Study group | Role | What they receive |
|---|---|---|
| A3384 Low dose | Experimental | Administered twice daily for the duration of the study Receives: Drug: A3384 |
| A3384 High dose | Experimental | Administered twice daily for the duration of the study Receives: Drug: A3384 |
| Placebo | Placebo comparator | Administered twice daily for the duration of the study Receives: Drug: A3384 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 weeks
Secondary outcomes (1)
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)
Measured: Baseline and 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bile Acid MalabsorptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albireo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02078856
- Sponsor's protocol ID
- A3384-001
- Status last verified
- Mar 2024
- First submitted
- 3 Mar 2014
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT02078856
- Acronym / sponsor ID
- A3384-001
- Conditions
- Bile Acid Malabsorption
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- AlbireoIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 5 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A3384 Low dose | Experimental | Drug: A3384Administered twice daily for the duration of the study |
| A3384 High dose | Experimental | Drug: A3384Administered twice daily for the duration of the study |
| Placebo | Placebo comparator | Drug: A3384Administered twice daily for the duration of the study |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A3384 | Drug | A3384 High dose, A3384 Low dose, Placebo |
Primary outcome
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).
Time frame: 2 weeks
1 secondary outcome
Secondary efficacy objectives of this study are to demonstrate the efficacy of different daily doses on other BM parameters and BAM/BAD symptoms
Time frame: Baseline and 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing A3384 in people with Bile Acid Malabsorption, run by Albireo at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.