Refractory Ascites in Patients With CirrhosisPhase 3ARAMNCT02818673
Refractory Ascitis Diagnosis by the Study of Labelled Albumin Pharmacokinetics
A Phase 3 study testing labelled human serumalbumin (125-I, Séralb®CisBio) and labelled albumin (99m-Tc, Vasculocis®, Cisbio) in people with Refractory Ascites in Patients With Cirrhosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Refractory ascites is an indication for liver transplantation, and includes ascites that is resistant to, or intractable by diuretic therapy (International Ascites Club). This definition is partly subjective; it can be established only a posteriori, following diuretic therapy administration to all patients, including… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Refractory Ascites in Patients With Cirrhosis
- What is being tested?
- labelled human serumalbumin (125-I, Séralb®CisBio) and labelled albumin (99m-Tc, Vasculocis®, Cisbio)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2017to Jan 2020
- Phase
- Phase 3
- 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
- patients consulting in Hepatology department of Beaujon Hospital
- aged 18 - 80 years old
- cirrhosis due to alcoholic and/or dysmetabolic and/or viral (HBV or HCV) cause, pathologically or clinically/biologically/radiologically proven.
- Volume of ascitis >5 L, either sensible or refractory to diuretics drugs according IAC criteria
Who cannot join
- infection in the 2 weeks prior to inclusion (suspected or proven)
- upper gastrointestinal bleeding du to portal hypertension in the 2 weeks prior to inclusion
- transjugular intrahepatic portosystemic shunt (TIPS)
- advanced hepatocellular carcinoma
- hepatic transplantation
- unability to stay lying for 6 hours
Show all 14Show fewer
- pregnancy / lactation
- renal deficiency (creat. clearance < 60ml/min)
- cardiac deficiency (≥ New York Heart Association (NYHA) III) or myocardial infarction (<3 months)
- other cause of ascitis
- contra-indication to human albumin (125-I) or vasculosis (99m-Tc) or other component of radio-pharmaceutics
- no health insurance coverage
- unability to go to the hospital for 1 day of exams
- refuse to consent to study participation
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Beaujon
Clichy, 92110
VALLA Dominique, MD, dominique.valla@aphp.fr
About this study
Official title: Refractory Ascitis Diagnosis by the Study of Labelled Albumin Pharmacokinetics Between Peritoneal and Vascular Compartments
Refractory ascites is an indication for liver transplantation, and includes ascites that is resistant to, or intractable by diuretic therapy (International Ascites Club). This definition is partly subjective; it can be established only a posteriori, following diuretic therapy administration to all patients, including those in whom untoward effects are prominent; and requires prolonged follow-up. An early diagnosis of refractory ascites would avoid giving diuretic therapy to patients in whom it will fail and identify rapidly candidates to liver transplantation. Such diagnosis could be done with a pharmacokinetic (PK) study of radiolabeled albumin between the peritoneal cavity and serum.
Read the detailed description
Main objective: assess the performances of PK parameters (transfer of labelled albumin) between peritoneal and vascular compartments, for the diagnosis of refractory ascitis, in patients with cirrhosis and abundant ascitis.
Design: proof of concept study. Interventional cross-sectional study in Beaujon Hospital (Clichy, France), 1 recruiting center and 1 non recruiting center.
Patients are recruited in the Hepatology department (Pr Valla) and PK exploration is performed in the nuclear medicine department (Pr Lebtahi) of Beaujon Hospital.
Description of intervention: diuretics treatment discontinuation 7 days before exploration for patients with sensitive ascitis, and more than 7 days for those with refractory ascitis. The day of exploration, the patients come to hospital and stay in lying position. One intra-veinous injection of 0,015 megabecquerel(MBq) /Kg labelled human serum albumin (Iode-125 (125-I), Séralb®CisBio), in compliance with market authorization, simultaneously to one intra-peritoneal injection of 200 MBq of labelled albumin (Technetium 99m (99m-Tc), Vasculocis®, Cisbio), off-label used. It follows 5 minutes mobilization of the patient (right and left lateral decubitus), then a scintigraphy will be performed using a gamma-camera Symbia T2 (Siemens®). Repeated blood (5 ml) and peritoneal ascitis (3 ml) samples are performed before injection and every 30 minutes for 6 hours (catheter in place). Diuretic treatment can be restarted the day after PK explorations. Patients are followed-up at 1 month by phone call (for the collection of adverse events).
Measurements : radioactivity measurements of 99m-Tc and 125-I in the biological samples are performed by a counter device in the nuclear medicine department (Wizard 3000, Packard®). Unidirectional transfer of labelled albumin (125-I) from vascular compartment (plasma-P) to peritoneal compartment (ascitis-A) (TPA), Unidirectional transfer of labelled albumin (99m-Tc) from peritoneal (A) to vascular compartment (P) (TAP), and the ratio TPA/TAP are calculated from these measurements using Matlab®.The gold standard is defined by the diagnosis of refractory ascitis performed before inclusion.
Statistical analyses: performances of the TAP, of the TPA, and of the ratio TPA/TAP for the diagnosis of refractory ascitis, will be computed using the Receiver Operating Characteristic (ROC) curve.
Number of patients : 30 patients (15 patients with refractory ascitis and 15 patients with sensitive or untreatable ascitis) will be included during a 24 months period (1 or 2 patients per month), and followed-up for 2 months. The PK explorations will be performed in nuclear medicine department not more than 4 weeks after inclusion. Total length of study will be of 26 months.
- Being tested
- labelled human serumalbumin (125-I, Séralb®CisBio), labelled albumin (99m-Tc, Vasculocis®, Cisbio)
- Keywords
- diagnostic performances, ascites
- Medical subject headings
- Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
labelled human serumalbumin (125-I, Séralb®CisBio)Radiation
Intra-veinous injection of 0,015 MBq/Kg ; 0,5 to 2 mL injected over less than a minute
labelled albumin (99m-Tc, Vasculocis®, Cisbio)Radiation
intra-peritoneal injection of 200 MBq of labelled albumin (99m-Tc, Vasculocis®, Cisbio) ; 5 ml injected over less than a minute
| Study group | Role | What they receive |
|---|---|---|
| Ascites in Patients With Cirrhosis | Experimental | Patients will be further classified according to the refractory or sensitive ascitis Receives: Radiation: labelled human serumalbumin (125-I, Séralb®CisBio); Radiation: labelled albumin (99m-Tc, Vasculocis®, Cisbio) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of refractory ascitis according to International Ascites Club (IAC)
Measured: Exploration day (4 weeks after the inclusion)
Secondary outcomes (5)
Measure of pharmacokinetics parameters : TPA
radioactivity measurements of labelled albumin (125-I) in ascitis (peritoneal samples) and plasma (blood samples)
Measured: Exploration day (4 weeks after the inclusion)
Measure of pharmacokinetics parameters : TAP
radioactivity measurements of labelled albumin (99m-Tc) in ascitis (peritoneal samples) and plasma (blood samples)
Measured: Exploration day (4 weeks after the inclusion)
Measure of pharmacokinetics parameters
Ratio TPA/TAP
Measured: Exploration day (4 weeks after the inclusion)
adverse events
Phone call
Measured: 1 month after exploration day
Proportion of patients in whom examination conditions and technical feasibility were completed
adequate volume of ascites,stable state of patient, satisfactory spread of radiopharmaceuticals in the peritoneal compartment measure by scintigraphy, number of peritoneal and blood samples performed
Measured: Exploration day (4 weeks after the inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startSep 2017 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Ascites in Patients With CirrhosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- VALLA Dominique, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818673
- Sponsor's protocol ID
- P140902
- Other IDs
- 2015-000157-20, 2015
- Acronym
- ARAM
- Status last verified
- Jun 2017
- First submitted
- 20 Jun 2016
- Last updated
- 15 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refractory Ascitis Diagnosis by the Study of Labelled Albumin Pharmacokinetics Between Peritoneal and Vascular Compartments
- ClinicalTrials.gov ID
- NCT02818673
- Acronym / sponsor ID
- ARAM / P140902
- Keywords
- diagnostic performances, ascites
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2017 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 30 Jun 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.
Refractory ascites is an indication for liver transplantation, and includes ascites that is resistant to, or intractable by diuretic therapy (International Ascites Club). This definition is partly subjective; it can be established only a posteriori, following diuretic therapy administration to all patients, including those in whom untoward effects are prominent; and requires prolonged follow-up. An early diagnosis of refractory ascites would avoid giving diuretic therapy to patients in whom it will fail and identify rapidly candidates to liver transplantation. Such diagnosis could be done with a pharmacokinetic (PK) study of radiolabeled albumin between the peritoneal cavity and serum.
Detailed description
Main objective: assess the performances of PK parameters (transfer of labelled albumin) between peritoneal and vascular compartments, for the diagnosis of refractory ascitis, in patients with cirrhosis and abundant ascitis.
Design: proof of concept study. Interventional cross-sectional study in Beaujon Hospital (Clichy, France), 1 recruiting center and 1 non recruiting center.
Patients are recruited in the Hepatology department (Pr Valla) and PK exploration is performed in the nuclear medicine department (Pr Lebtahi) of Beaujon Hospital.
Description of intervention: diuretics treatment discontinuation 7 days before exploration for patients with sensitive ascitis, and more than 7 days for those with refractory ascitis. The day of exploration, the patients come to hospital and stay in lying position. One intra-veinous injection of 0,015 megabecquerel(MBq) /Kg labelled human serum albumin (Iode-125 (125-I), Séralb®CisBio), in compliance with market authorization, simultaneously to one intra-peritoneal injection of 200 MBq of labelled albumin (Technetium 99m (99m-Tc), Vasculocis®, Cisbio), off-label used. It follows 5 minutes mobilization of the patient (right and left lateral decubitus), then a scintigraphy will be performed using a gamma-camera Symbia T2 (Siemens®). Repeated blood (5 ml) and peritoneal ascitis (3 ml) samples are performed before injection and every 30 minutes for 6 hours (catheter in place). Diuretic treatment can be restarted the day after PK explorations. Patients are followed-up at 1 month by phone call (for the collection of adverse events).
Measurements : radioactivity measurements of 99m-Tc and 125-I in the biological samples are performed by a counter device in the nuclear medicine department (Wizard 3000, Packard®). Unidirectional transfer of labelled albumin (125-I) from vascular compartment (plasma-P) to peritoneal compartment (ascitis-A) (TPA), Unidirectional transfer of labelled albumin (99m-Tc) from peritoneal (A) to vascular compartment (P) (TAP), and the ratio TPA/TAP are calculated from these measurements using Matlab®.The gold standard is defined by the diagnosis of refractory ascitis performed before inclusion.
Statistical analyses: performances of the TAP, of the TPA, and of the ratio TPA/TAP for the diagnosis of refractory ascitis, will be computed using the Receiver Operating Characteristic (ROC) curve.
Number of patients : 30 patients (15 patients with refractory ascitis and 15 patients with sensitive or untreatable ascitis) will be included during a 24 months period (1 or 2 patients per month), and followed-up for 2 months. The PK explorations will be performed in nuclear medicine department not more than 4 weeks after inclusion. Total length of study will be of 26 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ascites in Patients With Cirrhosis | Experimental | Radiation: labelled human serumalbumin (125-I, Séralb®CisBio), Radiation: labelled albumin (99m-Tc, Vasculocis®, Cisbio)Patients will be further classified according to the refractory or sensitive ascitis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients consulting in Hepatology department of Beaujon Hospital
- aged 18 - 80 years old
- cirrhosis due to alcoholic and/or dysmetabolic and/or viral (HBV or HCV) cause, pathologically or clinically/biologically/radiologically proven.
- Volume of ascitis >5 L, either sensible or refractory to diuretics drugs according IAC criteria
Key exclusion criteria (14 listed)
- infection in the 2 weeks prior to inclusion (suspected or proven)
- upper gastrointestinal bleeding du to portal hypertension in the 2 weeks prior to inclusion
- transjugular intrahepatic portosystemic shunt (TIPS)
- advanced hepatocellular carcinoma
- hepatic transplantation
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 |
|---|---|---|
| labelled human serumalbumin (125-I, Séralb®CisBio)Intra-veinous injection of 0,015 MBq/Kg ; 0,5 to 2 mL injected over less than a minute | Radiation | Ascites in Patients With Cirrhosis |
| labelled albumin (99m-Tc, Vasculocis®, Cisbio)intra-peritoneal injection of 200 MBq of labelled albumin (99m-Tc, Vasculocis®, Cisbio) ; 5 ml injected over less than a minute | Radiation | Ascites in Patients With Cirrhosis |
Primary outcome
Diagnosis of refractory ascitis according to International Ascites Club (IAC)
Time frame: Exploration day (4 weeks after the inclusion)
5 secondary outcomes
Measure of pharmacokinetics parameters : TPA
Time frame: Exploration day (4 weeks after the inclusion)
Measure of pharmacokinetics parameters : TAP
Time frame: Exploration day (4 weeks after the inclusion)
Measure of pharmacokinetics parameters
Time frame: Exploration day (4 weeks after the inclusion)
adverse events
Time frame: 1 month after exploration day
Proportion of patients in whom examination conditions and technical feasibility were completed
Time frame: Exploration day (4 weeks after the inclusion)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
- Individual participant dataSharing planned: Undecided
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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.
VALLA Dominique, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing labelled human serumalbumin (125-I, Séralb®CisBio) and labelled albumin (99m-Tc, Vasculocis®, Cisbio) in people with Refractory Ascites in Patients With Cirrhosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 4 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 15 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact VALLA Dominique, MD (06 09 17 81 28 ext. +33, dominique.valla@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of refractory ascitis according to International Ascites Club (IAC) (time frame: Exploration day (4 weeks after the inclusion)). 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 15 Jun 2017.