EMMPOWER: Efficacy and Safety of AXA1665 in Cirrhotic Subjects With Prior Overt Hepatic Encephalopathy

Sponsor

Axcella Health, Inc (Industry)

Overall Status

Terminated

CT.gov ID

NCT04816916

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

0.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a global study to compare the effects of AXA1665, an orally active mixture of amino acids, compared to placebo, on cognitive and physical function, as well as the safety and tolerability of AXA1665.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Encephalopathy	Drug: AXA1665 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of AXA1665 in Subjects With Liver Cirrhosis and Prior Overt Hepatic Encephalopathy (EMMPOWER)

Actual Study Start Date :

Jun 29, 2021

Actual Primary Completion Date :

Jun 30, 2022

Actual Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AXA1665 53.8 g per day AXA1665 administered orally TID	Drug: AXA1665 AXA1665 administered TID with food
Placebo Comparator: Matching placebo Placebo administered orally TID	Drug: Placebo Matching placebo administered TID with food

Arm

Intervention/Treatment

Experimental: AXA1665 53.8 g per day

AXA1665 administered orally TID

Drug: AXA1665

AXA1665 administered TID with food

Placebo Comparator: Matching placebo

Placebo administered orally TID

Drug: Placebo

Matching placebo administered TID with food

Outcome Measures

Primary Outcome Measures

Change in neurocognitive function by Psychometric Hepatic Encephalopathy Score (PHES) [Baseline to week 24]

Secondary Outcome Measures

Time to and frequency of recurrent overt hepatic encephalopathy [Baseline to week 24]
Impact on physical function assessed by Liver Frailty Index (a composite measure of hand grip strength, balance and ability to stand up from a chair) [Baseline to week 24]
Incidence of study product emergent adverse events (AEs) and serious adverse events (SAEs) [Baseline to week 24]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Willing to participate in the study and provide written informed consent.
Male and female adults aged ≥18 years.
History of cirrhosis and at least 1 prior episode of overt hepatic encephalopathy (OHE) prior to Screening.
A PHES of ≤ -4 during Screening.
MELD score of ≤ 22 at Screening.
Support of a primary caregiver who is able and willing to give written informed consent.

Exclusion Criteria:

Hospitalization or serious medical condition.
Presence of Child's-Pugh score ≥12, hepato-renal syndrome(s), refractory ascites, or spontaneous bacterial peritonitis (SBP).
History of a surgical portosystemic or a transjugular intrahepatic portosystemic shunt (TIPS) placement.
Expectation of a liver transplant during the study.
Use of marijuana or tetrahydrocannabinol (THC) within 1 week prior to Screening and during the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Francisco (UCSF)	San Francisco	California	United States	94143
2	OMEGA Research Consultants	DeBary	Florida	United States	32713
3	UF Hepatology Research at CTRB	Gainesville	Florida	United States	32610
4	Homestead Associates in Research	Miami	Florida	United States	33032
5	University of Miami	Miami	Florida	United States	33136
6	Indiana University School of Medicine	Indianapolis	Indiana	United States	46202
7	University of Iowa	Iowa City	Iowa	United States	52242
8	Mercy Medical Center	Baltimore	Maryland	United States	21202
9	New York University (NYU) School of Medicine	New York	New York	United States	10016
10	Weill Medical College of Cornell University	New York	New York	United States	10021
11	Cumberland Research Associates	Fayetteville	North Carolina	United States	28304
12	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
13	Medical University of South Carolina (MUSC)	Charleston	South Carolina	United States	29425
14	Optimed Research	Edinburg	Texas	United States	78359
15	Baylor Scott & White Research Institute	Fort Worth	Texas	United States	75246
16	Advanced Liver Therapies at St. Luke's Episcopal Hospital	Houston	Texas	United States	77030
17	Pinnacle Clinical Research	San Antonio	Texas	United States	78229
18	University of Virginia School of Medicine	Charlottesville	Virginia	United States	22903
19	Bon Secours Liver Institute	Newport News	Virginia	United States	23602
20	Virginia Commonwealth University	Richmond	Virginia	United States	23114
21	McGuire Research Institute, Inc., McGuire VA Medical Center	Richmond	Virginia	United States	23249
22	University of Calgary	Calgary	Alberta	Canada	T2N 4Z6
23	LMC Diabetes & Endocrinology Ltd. - London	London	Ontario	Canada	N6A 2C2
24	The Ottawa Hospital	Ottawa		Canada
25	Debreceni Egyetem Klinikai Kozpont	Debrecen		Hungary
26	Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz	Székesfehérvár		Hungary
27	Azienda Ospedaliera Universitaria Federico II	Naples		Italy	80131
28	Azienda sanitaria universitaria Friuli Centrale (ASU FC)	Udine		Italy	33100
29	KO - MED Centra Kliniczne Lublin II	Lublin		Poland
30	ID Clinic	Mysłowice		Poland
31	SONOMED Sp. z o.o.	Szczecin		Poland
32	Prywatna Specjalistyczna Praktyka Lekarska Jan Gietka	Warszawa		Poland
33	Centrum Badan Klinicznych Piotr Napora Lekarze Sp. p.	Wrocław		Poland
34	Corporacio Sanitaria Parc Tauli - Hospital de Sabadell	Barcelona		Spain
35	Hospital Universitario Vall d'Hebron	Barcelona		Spain
36	Hospital Universitario Puerta de Hierro	Majadahonda		Spain	28222
37	Hospital Universitario Marques de Valdecilla	Santander		Spain
38	Hospital Clinico Universitario de Santiago	Santiago De Compostela		Spain
39	Hospital Universitario Virgen del Rocio	Sevilla		Spain
40	The Royal Infirmary of Edinburgh	Edinburgh		United Kingdom