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SNCTP000002195 | NCT03008070 | BASEC2016-02129

Evaluation de l’efficacité et de la sécurité d’emploi de l’IVA337 chez des patients atteints de stéatose hépatique non alcoolique (SHNA)

Data source: BASEC (Imported from 29.03.2024), WHO (Imported from 29.03.2024)
Changed: Dec 23, 2023, 4:34 PM
Disease category: Nutritional and Metabolic diseases

Brief description of trial (Data source: BASEC)

L’étude incluera 225 patients atteints de Stéatose hépatique non alcoolique et répartis dans plusieurs pays en Europe et en Australie. Chaque participant sera assigné au hasard dans un groupe de traitement qui sera soit l’IVA337 (800 ou 1 200 mg) soit un placebo (forme pharmaceutique d’apparence identique au médicament à l’étude, mais ne contenant aucune substance active). L’IVA337 est un nouveau médicament qui agit spécifiquement sur le mécanisme de formation du tissu cicatriciel (fibrose), avec un nouveau mode d’action. Ni vous ni votre médecin ne saurez quel médicament vous recevez. Le traitement durera 24 semaines (6 mois).

Health conditions investigated(Data source: BASEC)

Stéatose hépatique non alcoolique (SHNA)

Health conditions (Data source: WHO)

Non-Alcoholic Steatohepatitis (NASH)

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

Etude interventionnelle, traitement assigné: l’IVA337 (800 ou 1 200 mg) ou un placebo (forme pharmaceutique d’apparence identique au médicament à l’étude, mais ne contenant aucune substance active)

Interventions (Data source: WHO)

Drug: IVA337;Drug: Placebo

Criteria for participation in trial (Data source: BASEC)

-Sujet homme ou femme agé de plus de 18 ans,
-Sujet atteint de stéatose hépatique non alcoolique (SHNA),
-Sujet d'accord de subir un biopsie du foie au terme du traitement

Exclusion criteria (Data source: BASEC)

-Sujet atteint d'une maladie du foie autre que la SHNA,
-Sujet avec un historique de consommation excessive d'alcool,
-Sujet avec des conditions métaboliques instables (instabilité du poids du sujet, diabète, prise de médicament antidiabétique ou contre l'obésité.

Inclusion/Exclusion Criteria (Data source: WHO)

Gender: All
Maximum age: N/A
Minimum age: 18 Years

Inclusion Criteria:

- Adult subjects, age =18 years.

- NASH histological diagnosis according to the currently accepted definition of both
EASL and AASLD, requiring the combined presence of steatosis (any degree = 5%) +
lobular inflammation of any degree + liver cell ballooning of any amount, on a liver
biopsy performed = 6 months before screening in the study or at screening and
confirmed by central reading during the screening period and

- SAF Activity score of 3 or 4 (>2)

- SAF Steatosis score = 1

- SAF Fibrosis score < 4

- Subject agrees to have a liver biopsy performed after 24 weeks of treatment.

- Compensated liver disease

- No other causes of chronic liver disease (autoimmune, primary biliary cholangitis,
Hepatitis B virus (HBV), hepatitis C virus (HCV), Wilson's, a-1-antitrypsin
deficiency, hemochromatosis, etc?).

- If applicable, have a stable type 2 diabetes, defined as HbA1c = 8.5% and fasting
glycemia <10 mmol/L, no changes in medication in the previous 6 months, and no new
symptoms associated with decompensated diabetes in the previous 3 months.

- Have a stable weight since the liver biopsy was performed defined by no more than a 5
% loss of initial body weight.

- Negative pregnancy test or post-menopausal. Women with childbearing potential (i.e.
fertile, following menarche and until becoming post-menopausal unless permanently
sterile) must be using a highly effective method of contraception (i.e. combined
(estrogen and progestogen containing) hormonal/ progestogen-only hormonal
contraception associated with inhibition of ovulation, intrauterine device,
intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised
partner). The contraceptive method will have to be followed for at least one
menstruation cycle after the end of the study

- Subjects having given her/his written informed consent.

Exclusion Criteria:

- Evidence of another form of liver disease.

- History of sustained excess alcohol ingestion: daily alcohol consumption > 30 g/day (3
drinks per day) for males and > 20 g/day (2 drinks per day) for females.

- Unstable metabolic condition: Weight change > 5kg in the last three months, diabetes
with poor glycemic control (HbA1c > 8.5%), introduction of an antidiabetic or of an
anti-obesity drug/malabsorptive or restrictive bariatric (weight loss) surgery in the
past 6 months prior to screening.

- History of gastrointestinal malabsorptive bariatric surgery within less than 5 years
or ingestion of drugs known to produce hepatic steatosis including corticosteroids,
high-dose estrogens, methotrexate, tetracycline or amiodarone in the previous 6
months.

- Significant systemic or major illnesses other than liver disease, including congestive
heart failure (class C and D of the American Heart Association , AHA), unstable
coronary artery disease, cerebrovascular disease, pulmonary disease, renal failure,
organ transplantation, serious psychiatric disease, malignancy that, in the opinion of
the investigator, would preclude treatment with IVA337 and/or adequate follow up.

- HB antigen >0, HCV Polymerase chain reaction (PCR) tests >0 (patients with a history
of HCV infection can be included if HCV PCR is negative since more than 3 years), HIV
infection.

- Pregnancy/lactation or inability to adhere to adequate contraception in women of
child-bearing potential.

- Active malignancy except cutaneous basocellular carcinoma.

- Any other condition which, in the opinion of the investigator would impede competence
or compliance or possibly hinder completion of the study.

- Body mass index (BMI) >45 kg/m2.

- Type 1 diabetes and type 2 diabetic patient on insulin.

- Diabetic ketoacidosis

- Fasting Triglycerides > 300 mg/dL.

- Hemostasis disorders or current treatment with anticoagulants.

- Contra-indication to liver biopsy.

- History of, or current cardiac dysrhythmias and/or a history of cardiovascular disease
event, including myocardial infarction, except patients with only well controlled
hypertension. Any clinically significant ECG abnormality reported by central ECG
reading.

- Participation in any other clinical study within the previous 3 months.

- Have a known hypersensitivity to any of the ingredients or excipients of the
Investigational medicinal product (IMP)

- Be possibly dependent on the Investigator or the sponsor (e.g., including, but not
limited to, affiliated employee).

- Creatine phosphokinase (CPK)>5 x ULN

- Osteopenia or any other well documented Bone disease. Patient without well documented
osteopenia treated with vitamin D and/or Calcium based supplements for preventive
reasons can be included.

(The criteria below are applicable only for patients who will undergo a MRI/LMS in selected
centers)

- Claustrophobia to a degree that prevents tolerance of MRI scanning procedure. Sedation
is permitted at discretion of investigator.

- Metallic implant of any sort that prevents MRI examination including, but not limited
to: aneurysm clips, metallic foreign body, vascular grafts or cardiac implants, neural
stimulator, metallic contraceptive device, tattoo, body piercing that cannot be
removed, cochlear implant; or any other contraindication to MRI examination.

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/ct2/show/NCT03008070

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT03008070
Further information on trial

Date trial registered

Dec 22, 2016

Recruitment status

Completed

Academic title (Data source: WHO)

A Randomized, Double-blind, Placebo-controlled, Multicenter, Dose-range, Proof-of-concept, 24-week Treatment Study of IVA337 in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).

Phase (Data source: WHO)

Phase 2

Primary end point (Data source: WHO)

SAF Activity Score (SAF-A) Decrease of at Least 2 Points With no Worsening of the CRN Fibrosis Score (CRN-F)

Secundary end point (Data source: WHO)

NASH Improvement;NASH Resolution and no Worsening of Fibrosis;Improvement of Fibrosis by at Least 1 Stage and no Worsening of NASH;Activity (SAF-A) Improvement;Steatosis (CRN-S) Improvement;Lobular Inflammation (CRN-I) Improvement;Hepatocyte Balooning (CRN-B) Improvement;Fibrosis (CRN-F) Improvement;Modified ISHAK Fibrosis (ISHAK-F) Improvement;Absolute Change in ALT;Absolute Change in AST;Absolute Change in GGT;Absolute Change in Fibrinogen;Absolute Change in Hs-CRP;Absolute Change in Alpha2 Macroglobulin;Absolute Change in Haptoglobulin;Absolute Change of Fasting Plasma Glucose;Absolute Change in Insulin;Absolute Change in HOMA Index;Absolute Change in HbA1c;Absolute Change in Total Cholesterol;Absolute Change of HDL-Cholesterol;Absolute Change of LDL-Cholesterol;Absolute Change in Triglycerides;Absolute Change in Apo A1;Absolute Change in Adiponectin;Resolution of NASH and Improvement of Fibrosis by at Least 1 Stage

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

https://clinicaltrials.gov/ct2/show/results/NCT03008070

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Bern, Geneva, Lugano

Countries (Data source: WHO)

Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Czechia, France, Germany, Italy, Mauritius, Netherlands, Poland, Portugal, Slovenia, Spain, Switzerland, United Kingdom, United States

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Urs Richenbacher
+41 61 465 70 40
vigilance@medius-ag.ch

Contact for general information (Data source: WHO)

Sven FRANCQUE, MD, PhD
Division of Gastroenterology and Hepatology, Antwerp University Hospital, Wilrijkstraat 10, B-2650 Edegem, Belgium

Contact for scientific information (Data source: WHO)

Sven FRANCQUE, MD, PhD
Division of Gastroenterology and Hepatology, Antwerp University Hospital, Wilrijkstraat 10, B-2650 Edegem, Belgium

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Kantonale Ethikkommission Bern

Date of authorisation by the ethics committee

09.03.2017

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2016-02129

Secondary ID (Data source: WHO)

2016-001979-70
IVA_01_337_HNAS_16_002
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