Scientific study on the efficacy and safety of Nor-ursodeoxycholic acid tablets in the treatment of patients with non-alcoholic steatohepatitis

ID di studio ICTRP
EUCTR2018-003443-31 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
Double-blind, randomised, placebo-controlled, phase IIb trial on the efficacy and safety of norursodeoxycholic acid tablets in patients with non-alcoholic steatohepatitis (NASH) (BASEC)

Titolo accademico
Double-blind, randomised, placebo-controlled, phase IIb trial on the efficacy and safety of norursodeoxycholic acid tablets in patients with non-alcoholic steatohepatitis (NASH) - Norursodeoxycholic acid vs. placebo in NASH (ICTRP)

Titolo pubblico
Clinical trial comparing the efficacy and safety of norursodeoxycholic acid tablets with placebo in the treatment of non-alcholic fatty liver disease with liver inflammation ("non-alcoholic steatohepatitis"[NASH]) (ICTRP)

Malattie studiate
Non-alcoholic steatohepatitis (NASH)
MedDRA version: 24.1Level: PTClassification code 10053219Term: Non-alcoholic steatohepatitisSystem Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] (ICTRP)

Intervento studiato

Product Name: Norursodeoxycholic acid (NorUDCA)
Pharmaceutical Form: Tablet
INN or Proposed INN: Norursodeoxycholic acid
CAS Number: 9697-24-2
Current Sponsor code: norUDCA
Other descriptive name: NOR-URSODEOXYCHOLIC ACID
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

(ICTRP)

Tipo di studio
Interventional clinical trial of medicinal product (ICTRP)

Disegno dello studio
Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: yes Other specify the comparator: Two different doses of IMP (1500 mg/d or 1000 mg/d norUDCA) Number of treatment arms in the trial: 3 (ICTRP)

Criteri di inclusione/esclusione
Gender:
Female: yes
Male: yes

Inclusion criteria:
? Must be willing to participate in the study and provide written informed consent
? Male or female patients = 18 and < 75 years
? Centrally assessed histological evidence of NASH and liver fibrosis
? Women of childbearing potential agree to use a highly effective method of birth control during the entire duration of the trial and for 4 weeks following the last dose of trial treatment

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 298
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 65
(ICTRP)

Exclusion criteria:
? Patients taking prohibited medications
? Presence of liver cirrhosis
? Type 1 diabetes or uncontrolled Type 2 diabetes
? History or presence of any other significant concomitant liver diseases
? History of liver transplantation
? BMI >45 kg/m^2
? Any known relevant infectious disease (e.g., active tuberculosis, acquired immunodeficiency syndrome [AIDS]-defining diseases)
? Abnormal renal function (glomerular filtration rate estimated from cystatin C < 30 ml/min) at screening visit
? Any active malignant disease (except for basal cell carcinoma)
? Existing or intended pregnancy or breast-feeding


Endpoint primari e secondari
Main Objective: To evaluate the efficacy of norursodeoxycholic acid (norUDCA) 1500 mg vs. norUDCA 1000 mg vs. placebo for the treatment of NASH ;Secondary Objective: To study safety and tolerability (adverse events [AEs], laboratory parameters) of norUDCA;Primary end point(s): Resolution of NASH, assessed by centrally scored liver histology, and no worsening of fibrosis from baseline to EOT/withdrawal visit
AND/OR
Improvement of fibrosis, and no worsening of NAS from baseline to EOT/withdrawal visit
;Timepoint(s) of evaluation of this end point: week 72 (EOT)/withdrawal visit (ICTRP)

Secondary end point(s): ? Improvement of NASH and no worsening of fibrosis from baseline to EOT/withdrawal
? Change in NAS from baseline to EOT/withdrawal visit
? ALT = 0.8 ULN at EOT/withdrawal visit;Timepoint(s) of evaluation of this end point: week 72 (EOT)/withdrawal visit (ICTRP)

Data di registrazione
09.04.2019 (ICTRP)

Inclusione del primo partecipante
08.05.2019 (ICTRP)

Sponsor secondari
non disponibile

Contatti aggiuntivi
Department of Clinical Research, zentrale@drfalkpharma.de, +4976115140, Dr. Falk Pharma GmbH (ICTRP)

ID secondari
NUT-3/NAS, 2018-003443-31-CZ (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-003443-31 (ICTRP)