Overview

Clinical Trial to Investigate the Anti-oxidant Activity of Heptex in Patients With Apparent Risk Factors of NASH

Status:
Completed
Trial end date:
2022-02-21
Target enrollment:
0
Participant gender:
All
Summary
A Phase II, Randomized, Double Blind, Placebo-Controlled Clinical Trial to Investigate the Anti-oxidant Activity of Heptex in Patients with Apparent Risk Factors of Nonalcoholic Steatohepatitis (NASH)
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Natural Wellness Egypt
Collaborators:
Ain Shams University
National Hepatology & Tropical Medicine Research Institute
Criteria
Inclusion Criteria:

1. Male or female aged between 18 and 65 years.

2. Both male and female patients who have childbearing potential must agree to practice
an acceptable method of birth control during the study and for at least 6 months after
the cessation of treatment; such contraceptive methods must include at least one
barrier method.

3. Controlled Attenuation Parameter (CAP)-confirmed hepatic steatosis.

4. Patients with elevated serum aspartate aminotransferase (AST) and alanine
aminotransferase (ALT) levels but less than 2.5 times the upper limit of the normal
range.

5. Liver fibrosis stage F1-F2 as diagnosed by the FibroScan liver stiffness measurement
of 5-10 kPa.

6. Liver condition according the following criteria;

- Serum albumin > 3 g/dl

- INR < 2

- No ascites on ultrasound

- No documented or suspected hepatic encephalopathy

7. Willing to stop any other liver support and hepatoprotective medications throughout
study duration.

8. Able and willing to provide written informed consent.

9. Able and willing to complete all study visits and procedures, including compliance
with the requirements and restrictions listed in the consentform.

Exclusion Criteria:

1. Pregnant or lactating women.

2. Patients with BMI > 40 Kg/m2 or BMI < 18.5 Kg/m2.

3. Serum creatinine > 1.5 x ULN OR creatinine clearance (GFR) < 60 mL/minute.

4. Platelet count < 75,000/mm3.

5. Uncontrolled diabetes mellitus as evident by HbA1c ≥ 8.5%.

6. Patients who are currently receiving Thiazolidinediones.

7. Patients with ischemic heart disease (IHD).

8. History of parenteral nutrition.

9. History of liver transplant.

10. Viral hepatitis, drug-induced liver injury, metabolic liver disease or auto-immune
liver disease.

11. Liver cancer or serum alpha-fetoprotein (AFP) >100ng/ml. Patients with an AFP between
50 and 100ng/ml may be included as long as a liver ultrasound within 3 months of
screening, or at screening, shows no evidence of potential hepatocellular cancer.

12. Use of drugs known to induce steatosis (valproate, amiodarone or prednisone) or to
affect body weight and carbohydrate metabolism.

13. Use of drugs known to alter liver enzymes.

14. Allergy or allergic history to any of the drug components.

15. History of alcohol abuse as assessed by the investigator within the past 2 years, or
an alcohol use pattern that may interfere with the patient's study compliance.
Patients must have abstained from alcohol for at least 6 months prior to study start.

16. Patients with history of clinically-significant illness or any other major medical
disorder that may interfere with subject treatment, assessment, or compliance with the
protocol.

17. Receipt of an investigational drug within 6 months prior to screening, or active
enrolment in another investigational medication or device trial.

18. Patients with any chronic illness or prior treatment which in the opinion of the
investigator should preclude participation in the trial.

19. Inability to understand and cooperate with the investigators or to give valid consent.