Informations générales (source: ClinicalTrials.gov)
A Multicentre, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and the Safety of ALF-5755 in Patients With Nonacetaminophen Severe Acute Hepatitis and Early Stage Acute Liver Failure
Interventional
Phase 2
Alfact Innovation (Voir sur ClinicalTrials)
octobre 2010
septembre 2012
29 juin 2024
Acute liver failure is a rare but dramatic disease, often affecting young people, marked
by the sudden loss of liver function in a person without preexisting liver disease.
ALF-5755 has been shown to promote cell survival after apoptotic or oxidative stress, and
liver cell regeneration in primary cultures and in vivo. ALF-5755 may become, in this
dramatic disease with high unmet medical need, a future therapy for the treatment of
patients suffering from severe acute hepatitis (SAH) and acute liver failure (ALF) not
due to acetaminophen overdose, where liver transplantation is the sole treatment in the
absence of spontaneous recovery.
The primary objective of the study is to evaluate the efficacy of ALF-5755 versus
placebo.
A minimum of 60 patients will be recruited into the study in the following two treatment
groups:
- Group A: approximately 30 patients will receive ALF-5755
- Group B: approximately 30 patients will receive placebo (physiological saline
solution: 0.9% NaCl)
Patients will receive 10 mg (25 ml) of ALF5755 or placebo every 12 hours over 3 days in
slow intravenous infusions over 10 minutes using automatic syringes.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Beaujon | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Paul Brousse | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Saint Antoine | Contact (sur clinicalTrials) | ||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Clermont-Ferrand - 63003 - Clermont-Ferrand Cedex 1 - France | Contact (sur clinicalTrials) | ||||
| CHU de Besançon - 25030 - Besançon Cedex - France | Contact (sur clinicalTrials) | ||||
| Hôpital Claude Huriez - 59037 - Lille cedex - France | Contact (sur clinicalTrials) | ||||
| Hôpital Conception - 13385 - Marseille Cedex 5 - France | Contact (sur clinicalTrials) | ||||
| Hôpital Croix-Rousse - 69004 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Hôpital de l'Archet 2 - 06202 - Nice - France | Contact (sur clinicalTrials) | ||||
| Hôpital Saint-Eloi - 34295 - Montpellier Cedex 5 - France | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU de Grenoble - 38043 - Grenoble Cedex 9 - France | Contact (sur clinicalTrials) | ||||
| Hôpital La Pitié Salpétrière - 75651 - Paris Cedex 13 - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- A signed written informed consent from patient or from patient's next of kin or from
an authorized person according to local procedures
- Early stage acute liver failure OR severe acute hepatitis defined as:
- 15% ≤ PR < 50%
- No hepatic encephalopathy, OR grade I or II encephalopathy (Appendix E)
- Presumed acute illness onset of less than 26 weeks
- No evidence of underlying chronic liver disease
- Patient who can receive first treatment dose within the first 48 hours after
biological baseline assessment
- Age ≥ 18 and ≤ 65 years
- Contraception (only for females of childbearing potential) to be taken throughout
the study until D21. Sole mechanic contraceptives, such as condoms, are advised.
Note: Oral contraceptives may have contraindications in case of severe acute
hepatitis and acute liver failure
- Patient affiliated to social security insurance system.
- A signed written informed consent from patient or from patient's next of kin or from
an authorized person according to local procedures
- Early stage acute liver failure OR severe acute hepatitis defined as:
- 15% ≤ PR < 50%
- No hepatic encephalopathy, OR grade I or II encephalopathy (Appendix E)
- Presumed acute illness onset of less than 26 weeks
- No evidence of underlying chronic liver disease
- Patient who can receive first treatment dose within the first 48 hours after
biological baseline assessment
- Age ≥ 18 and ≤ 65 years
- Contraception (only for females of childbearing potential) to be taken throughout
the study until D21. Sole mechanic contraceptives, such as condoms, are advised.
Note: Oral contraceptives may have contraindications in case of severe acute
hepatitis and acute liver failure
- Patient affiliated to social security insurance system.
- Acetaminophen-induced hepatitis defined as acetaminophen intake > 4 g/day, at least
once in the 7 days prior to baseline
- Shock liver (ischemic hepatopathy) OR HELLP syndrome OR Budd-Chiari syndrome OR
intrahepatic malignancy
- Serum creatinine ≥ 180 μmol/L
- Body Mass Index (BMI) ≥ 35
- Septic shock requiring administration of inotropic drugs
- Uncontrolled active bleeding
- Patients who received fresh frozen plasma, PPSB (Prothrombin-Proconvertin-Stuart-B),
or vitamin K infusion over the last 48 hours
- Patient receiving liver support device treatment, including but not exclusively
bioartificial liver (BAL), Extracorporeal Liver Assist Device (ELAD), transgenic pig
perfusion
- Patient receiving hemodialysis, hemofiltration or hemodiafiltration treatment
- Intractable arterial hypotension (arterial systolic blood pressure equal to or below
70 mmHg) present or require inotropic drugs at baseline
- Human Immunodeficiency Virus (HIV) positive patient
- Active cancer
- Pregnancy or breast-feeding
- Surgery within 4 weeks prior to baseline, or unsolved surgical disease outside liver
transplantation.
- Patient included in another clinical trial within 4 weeks prior to baseline
- Patient with organ or bone-marrow allograft
- Absolute contra-indication to liver transplantation.