Effect of lycosomal formulations of lycopene and resveratrol chaperoned with phosphatidylcholine on progression and outcomes of Hepatitis C.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000645550
• Date of registration: 23/06/2015
• Prospective Registration: No
• Primary sponsor: Lycotec Ltd, Cambridge, UK
• Public title: Effect of lycosomal formulations of lycopene and resveratrol chaperoned with phosphatidylcholine on progression and outcomes of Hepatitis C.
• Scientific title: Effect of lycosomal formulation of lycopene and resveratrol chaperoned phosphatidylcholine on viral load and liver function in patients with hepatitis c
• Date of first enrolment: 04/03/2015
• Target sample size: 120
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12615000645550.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Phase 2

Countries of recruitment

United Kingdom, Uzbekistan

Contacts

• Name: Dr Yuriy K Bashmakov MD, PhD

• Name: Dr Ivan M Petyaev MD, PhD

Key inclusion & exclusion criteria

Inclusion criteria: 1. Consented males or females 18-65 years of age and testing positive for any HCV genotype on the standard interferon therapy.
2. Newly diagnosed cases of Hepatitis C as well as patients with chronic Hepatitis C patients positive in quantitative and qualitative PCR with concomitant increase of liver-specific enzymes in serum (>2 folds over control level).
3. Stable clinical conditions not requiring emergency care

Exclusion criteria: 1. Clinically significant infection, other than HCV, defined as any acute viral, bacterial, or fungal infection, which requires specific therapy.
2. Co-infections with Hepatitis B virus and Human immunodeficiency virus (HIV).
3. Received any investigational drug agent(s) within 28-days of entry into study.
4. Any known pre-existing medical condition that could interfere with the subject's participation in the protocol, including serious psychiatric disorders, CNS trauma or active seizure disorders requiring medication, poorly controlled diabetes mellitus, significant cardiovascular dysfunction within the past 6 months (e.g., angina, congestive heart failure, recent myocardial infarction, severe hypotension, or significant arrhythmia).
5. Subjects with ECG showing clinically significant abnormalities.
6. Need for frequent blood transfusions.
7. Recent History of bleeding or bleeding disorders requiring the restriction in use of anticoagulants during study treatments.
8. Active immunologically mediated disease (e.g., inflammatory bowel disease [Crohn's disease, ulcerative colitis], rheumatoid arthritis, idiopathic thrombocytopenia purpura, systemic lupus erythematosus, autoimmune or inherited hemolytic anemia, scleroderma, severe psoriasis).
9. Any medical condition, other than HCV, requiring, or likely to require during the course of the study, chronic systemic administration of steroids or other immune-regulatory medications.
10. Substance abuse, such as alcohol (~80 gm/day), IV drugs, and inhaled drugs (If the subject has a history of substance abuse, to be considered for inclusion into the protocol, the subject must have abstained from using the abused substance for at least 2 months.
11. Any cancer requiring systemic chemotherapy.
12. Any other condition that, in the opinion of the principal investigators or treating physicians, would make the subject unsuitable for enrollment, or could interfere with the subject participating in and completing the expanded access protocol.


Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Alternative and Complementary Medicine - Herbal remedies

Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Hepatitis C;
Hepatitis C

Infection - Other infectious diseases

Intervention(s)

The study consists of 3 separate groups of patients. Each group of the patients will be assigned to take orally after meals one of the following Lycosome formulations of phytochemicals:
1. Phospho-PTDC-chaperone (450 mg twice daily).
2. Combinatory lycosomal formulation of Lycopene (7 mg) fused with Phospho-PTDC-chaperone (450 mg) taken twice daily.
3. Combinatory lycosomal formulation of trans-Resveratrol (240 mg), lycopene (7 mg) and phospho-PTDC-chaperone (450 mg) taken twice daily.

All formulations will be taken for the same period of 6 months.
Adherence to the protocol will be monitored by questioning of the patients and determination of plasma levels of lycopene and resveratrol before and after completion of the study by methods of analytic chemistry.

Primary Outcome(s)

Primary objective of this clinical trial is to verify an effect of lycosomal formulations of lycopene and resveratrol chaperoned with phosphatidylcholine on HCV viral load as determined by quantitative polymerase chain reaction protocol.

[End of 6th month of interventional period.]

Another study outcome is to verify an effect of lycosomal formulations of lycopene and resveratrol chaperoned with phosphatidylcholine on
liver functions as assessed by biochemical measurements of liver-specific enzymes (alanin- and aspartat-aminotransferases, gamma-glutamyltranspeptidase and others}.[End of the 6th month of interventional period]

Secondary Outcome(s)

Investigation of the effect of lycosomal formulation of lycopene and resveratrol chaperoned with phosphatidylcholine on immunological profile of patients with Hepatitis C by measurement of populations of B- and T-lymphocytes using flow cytometry.[end of 4th and 6th months of interventional time period.]

Investigation of the effect of lycosomal formulation of lycopene and resveratrol chaperoned with phosphatidylcholine on HCV viral load in patients with different HCV genotypes as determined by quantitative polymerase chain reaction.


[end of 4th and 6th months of interventional time period.]

Investigation of the effect of lycosomal formulation of lycopene and resveratrol chaperoned with phosphatidylcholine on inflammatory status as determined by measurements of C-reactive protein, Interleukin-6 and -10 levels using analytic chemistry methods. [end of 4th and 6th months of interventional time period.]

Secondary ID(s)

None

Source(s) of Monetary Support

Lycotec Ltd

Secondary Sponsor(s)

NUTRA Sp. Z.o.o.

Ethics review

Status: Approved
Approval date:
Contact:

Institutional review board