Remaxol® in Malignant Mechanical Jaundice

• Status: Completed
• Trial end date: 2020-03-04
• Target enrollment: 0
• Participant gender: All

Summary

The trial intends to study the safety and efficacy of Remaxol® (succinate + methionine + inosine + nicotinamide; POLYSAN Ltd., Russia),solution for infusion for the reduction of hyperbilirubinemia in patients with obstructive jaundice caused by tumor (malignancy).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company; Scientific Technological Pharmaceutical Firm Polysan, Ltd.
• Treatments: Niacin; Niacinamide; Nicotinic Acids; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

1. Presence of signed informed consent for participation in the study.

2. Men and women over 18 years of age (incl.).

3. Demonstrated by one or several instrumental methods (ultrasound, cholangiography, CT or MRI) enlargement of intrahepatic bile ducts with visualized obturation of the main bile ducts caused by tumor.

4. Duration of mechanical jaundice less than 30 days, including the first day of the screening period.

5. The status by the classifications Eastern Cooperative Oncology Group (ECOG) scale is 0-2.

6. Life expectancy of more than 3 months.

7. Laboratory data corresponding to the following cutoff limits :

hemoglobin ≥90 g / l; neutrophils ≥ 1.5x109 / l; Platelets ≥ 75 x 109 / L; AsAT and / or AlAT above 3 х normal but less than 25 х normal Serum creatinine not exceeding 2 × normal, Serum potassium within normal limits

8. Negative urine test for pregnancy in women of reproductive age.

9. For reproductive age: consent to use adequate methods of contraception or for complete abstinence from sexual activity for the period of the study.

Exclusion Criteria:

1. Radical surgery planned within 10 days from the date of randomization.

2. Liver metastases with the biliary block at the level of segmental ducts.

3. Suspicion of metastases in the central nervous system or metastatic arachnoiditis during physical examination; clinically significant ascites.

4. Acute destructive pancreatitis, diffuse peritonitis, ongoing bleeding of any etiology, sepsis (procalcitonin test of 10 ng / ml and above).

5. Liver cirrhosis

6. Presence of clinically significant cardiovascular diseases: chronic cardiac insufficiency III-IV functional class by NYHA, uncontrolled arterial hypertension, acute stroke or acute myocardial infarction in the previous 3 months, unstable angina, uncontrolled arrhythmia and severe heart rhythm disturbances.

7. Pregnancy or lactation.

8. Hypersensitivity to any component of the study drug / placebo and / or intolerance to any component of the study drug / placebo.

9. Regular intake of medications prohibited or not permitted by the study protocol within 4 weeks prior to enrollment or medical indication tio start any medication prohibited or not permitted by the study protocol

10. Concomitant chronic systemic immune or hormonal therapy.

11. Gout.

12. Alcohol and/or drug dependence.

13. Active tuberculosis, HIV infection, syphilis, acute viral hepatitis.

14. Any other conditions / diseases that may interfere with the patient's compliance with the requirements of the Protocol.

15. Mental, physical and other reasons that do not allow the patient to comply with the requirements of the study protocol.

16. Any other significant (by judgement of the investigator) condition that prevents the patient from entering the study.

17. Participation in any clinical trial in the previous 3 months.

18. Staff of the research center and their family members.