Acute-On-Chronic Liver FailurePhase 2HEP101NCT02946554
Phase II Safety Study of 2 Dose Regimens of HepaStem in Patients With ACLF
A Phase 2 study testing HepaStem in people with Acute-On-Chronic Liver Failure, run by Cellaion SA at 10 sites in 2 countries.
Trial summary
The study will assess the safety of different dose regimens of HepaStem in cirrhotic Patients with ACLF or with acute decompensation at risk of developing ACLF up to Day 28 of the active study period. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute-On-Chronic Liver Failure
- What is being tested?
- HepaStem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Dec 2016to Jul 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Diagnosed cirrhosis
- Patient with Acute Decompensation of cirrhosis
- Serum total Bilirubin ≥ 6 mg/dL (≥100 umol/L)
- The INR measurement has to be : 1.2 ≤ INR < 2
Main Exclusion Criteria:
- Absence of portal vein flow
- Known or medical history of thrombotic events
- Gastrointestinal hemorrhage requiring blood transfusion
- Variceal bading or sclerosis within 4 weeks before infusion
- Septic shock or non-controlled bacterial infection
- Clinical evidence of aspergilus infection.
- Circulatory failure
- Respiratory disordered
- Coagulation disorders defined as INR ≥ 2, Fibrinogen < 100 mg/dL or Platelets < 50.000/mm3
- MELD score > 30.
- Major invasive procedure within 4 weeks before infusion
- Previous organ transplantation and/or ongoing immunosuppressive treatments.
- Renal failure due to chronic kidney disease.
- Clinically significant left-right cardiac shunt.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Belgium7 sites
CHU Brugmann
Brussels, 1020
Hôpital Erasme
Brussels, 1070
UZ Antwerpen
Edegem, 2650
UZ Gent
Ghent, 9000
KU Leuven
Leuven, 3000
CHU de Liège
Liège, 4000
Cliniques St Luc
Woluwe-Saint-Lambert, 1200
France3 sites
Hôpital Beaujon
Clichy, 92110
Hôpital de la Croix Rousse
Lyon, 69004
Hôpital Paul Brousse
Villejuif, 94804
About this study
Official title: Multicenter Phase II Safety and Preliminary Efficacy Study of 2 Dose Regimens of HepaStem in Patients With Acute on Chronic Liver Failure
The study will assess the safety of different dose regimens of HepaStem in cirrhotic Patients with ACLF or with acute decompensation at risk of developing ACLF up to Day 28 of the active study period.
- Conditions
- Acute-On-Chronic Liver Failure
- Being tested
- HepaStem
- Keywords
- Acute-On-Chronic Liver Failure, ACLF
- Medical subject headings
- Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HepaStemBiological
| Study group | Role | What they receive |
|---|---|---|
| Low dose cohort | Other | Two dose regimens of HepaStem will be given, which differ in the amount of cells per infusion.
The low dose regimen will be given to the first cohort (first 6 patients included in the study). Receives: Biological: HepaStem |
| High dose cohort | Other | The high dose regimen will be given to the second cohort after evaluation of the safety of the 1st cohort (stepwise approach) Receives: Biological: HepaStem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessed by occurence of Adverse Events (AE) up to Day 28 of the active study period
Measured: up to 28Day post first infusion day
Secondary outcomes (3)
Efficacy assessed by clinical parameters
Clinical efficacy parameters evaluated by mortality, liver transplantation and disease scoring.
Measured: 28Day, 3 month and 1 year post first infusion day
Efficacy assessed by biological parameters
Biological efficacy parameters evaluated by bilirubin, creatinine, INR and albumin values
Measured: 28Day, 3 month and 1 year post first infusion day
Long term safety Follow up assessed by the occurence of Adverse Event of Special Interest
Adverse Event of Special Interest defined as : SAE (Serious Adverse Event) with fatal
Measured: 3 month and 1 year post first infusion day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study startDec 2016
- Primary completionJul 2019
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute-On-Chronic Liver FailureStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cellaion SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946554
- Sponsor's protocol ID
- HEP101
- Acronym
- HEP101
- Status last verified
- Oct 2020
- First submitted
- 13 Oct 2016
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Phase II Safety and Preliminary Efficacy Study of 2 Dose Regimens of HepaStem in Patients With Acute on Chronic Liver Failure
- ClinicalTrials.gov ID
- NCT02946554
- Acronym / sponsor ID
- HEP101 / HEP101
- Conditions
- Acute-On-Chronic Liver Failure
- Keywords
- Acute-On-Chronic Liver Failure, ACLF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cellaion SAIndustry (pharma, biotech, devices)
- Study start
- Dec 2016 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 27 Oct 2016 (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 study will assess the safety of different dose regimens of HepaStem in cirrhotic Patients with ACLF or with acute decompensation at risk of developing ACLF up to Day 28 of the active study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose cohort | Other | Biological: HepaStemTwo dose regimens of HepaStem will be given, which differ in the amount of cells per infusion. The low dose regimen will be given to the first cohort (first 6 patients included in the study). |
| High dose cohort | Other | Biological: HepaStemThe high dose regimen will be given to the second cohort after evaluation of the safety of the 1st cohort (stepwise approach) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| HepaStem | Biological | High dose cohort, Low dose cohort |
Primary outcome
Safety assessed by occurence of Adverse Events (AE) up to Day 28 of the active study period
Time frame: up to 28Day post first infusion day
3 secondary outcomes
Efficacy assessed by clinical parameters
Time frame: 28Day, 3 month and 1 year post first infusion day
Efficacy assessed by biological parameters
Time frame: 28Day, 3 month and 1 year post first infusion day
Long term safety Follow up assessed by the occurence of Adverse Event of Special Interest
Time frame: 3 month and 1 year post first infusion day
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 14 Oct 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 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 HepaStem in people with Acute-On-Chronic Liver Failure, run by Cellaion SA at 10 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?
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 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Belgium, France. 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. 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?
Safety assessed by occurence of Adverse Events (AE) up to Day 28 of the active study period (time frame: up to 28Day post first infusion day). 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 14 Oct 2020.