Efficacy & Safety of ALF-5755 in Patients With Nonacetaminophen Severe Acute Hepatitis & Early Stage Acute Liver Failure
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Alfact Innovation.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Alfact Innovation
Information provided by:
Alfact Innovation
ClinicalTrials.gov Identifier:
NCT01318525
First received: March 17, 2011
Last updated: April 4, 2011
Last verified: April 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Failure, Acute |
Drug: ALF-5755 Drug: Saline solution (0.9% NaCl) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Alfact Innovation:
Primary Outcome Measures:
- Rate of change of Prothrombin Rate initiation [ Time Frame: Over a period of 72 hours from baseline ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Rate of change of Factor V (FV) plasma level [ Time Frame: Over a period of 72 hours from baseline ] [ Designated as safety issue: No ]
- Rate of change of international normalized ratio (INR) [ Time Frame: Over a period of 72 hours from baseline ] [ Designated as safety issue: No ]
- Rate of change of alanine transaminases (ALT) plasma level [ Time Frame: Over a period of 72 hours from baseline ] [ Designated as safety issue: No ]
- Rate of change of aspartate transaminases (AST) plasma level [ Time Frame: Over a period of 72 hours from baseline ] [ Designated as safety issue: No ]
- Change of Hepatic Encephalopathy Grade (HE grade) [ Time Frame: Over a period of 72 hours from baseline ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: ALF-5755 |
Drug: ALF-5755
10 mg (25 ml) given in slow intravenous infusion over 10 minutes with an automatic syringe
|
| Placebo Comparator: Saline solution (0.9% NaCl) |
Drug: Saline solution (0.9% NaCl)
25 ml given in slow intravenous infusion over 10 minutes with an automatic syringe
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01318525
Contacts
| Contact: Paul Amouyal | +33 1 45 59 35 66 | amouyal.paul@wanadoo.fr |
Locations
| France | |
| CHU de Besançon | Not yet recruiting |
| Besançon Cedex, France, 25030 | |
| Principal Investigator: Vincent Di Martino | |
| CHU Clermont-Ferrand | Not yet recruiting |
| Clermont-Ferrand Cedex 1, France, 63003 | |
| Principal Investigator: Armand Abergel | |
| Hôpital Beaujon | Recruiting |
| Clichy, France, 92110 | |
| Principal Investigator: François Durand | |
| CHU de Grenoble | Recruiting |
| Grenoble Cedex 9, France, 38043 | |
| Principal Investigator: Vincent Leroy | |
| Hôpital Claude Huriez | Not yet recruiting |
| Lille cedex, France, 59037 | |
| Principal Investigator: Philippe Mathurin | |
| Hôpital Croix-Rousse | Recruiting |
| Lyon, France, 69004 | |
| Principal Investigator: Si Nafa Si Ahmed | |
| Hôpital Conception | Not yet recruiting |
| Marseille Cedex 5, France, 13385 | |
| Principal Investigator: Danielle Botta Fridlund | |
| Hôpital Saint-Eloi | Recruiting |
| Montpellier Cedex 5, France, 34295 | |
| Principal Investigator: Dominique Larrey | |
| Hôpital de l'Archet 2 | Not yet recruiting |
| Nice, France, 06202 | |
| Principal Investigator: Jean Gugenheim | |
| Hôpital Saint Antoine | Recruiting |
| Paris Cedex 12, France, 75571 | |
| Principal Investigator: Nicolas Carbonell | |
| Hôpital La Pitié Salpétrière | Recruiting |
| Paris Cedex 13, France, 75651 | |
| Principal Investigator: Marika Rudler | |
| Centre Hépatobiliaire Paul Brousse | Recruiting |
| Villejuif Cedex, France, 94804 | |
| Principal Investigator: Didier Samuel | |
Sponsors and Collaborators
Alfact Innovation
Investigators
| Study Director: | Paul Amouyal | Alfact Innovation |
More Information
Publications:
| Responsible Party: | Paul Amouyal, Alfact Innovation |
| ClinicalTrials.gov Identifier: | NCT01318525 History of Changes |
| Other Study ID Numbers: | ALF-5755_P2_ALF |
| Study First Received: | March 17, 2011 |
| Last Updated: | April 4, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Liver Failure Liver Failure, Acute Liver Diseases Digestive System Diseases |
Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepatic Insufficiency |
ClinicalTrials.gov processed this record on May 23, 2013