Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000645550
Ethics application status
Approved
Date submitted
12/02/2015
Date registered
23/06/2015
Date last updated
23/06/2015
Type of registration
Retrospectively registered

Titles & IDs
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
Secondary ID [1] 286157 0
None
Universal Trial Number (UTN)
U1111-1167-1471
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 294163 0
Condition category
Condition code
Infection 294492 294492 0 0
Other infectious diseases
Alternative and Complementary Medicine 294914 294914 0 0
Herbal remedies
Oral and Gastrointestinal 294915 294915 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 291163 0
Treatment: Drugs
Comparator / control treatment
Control patients will be given oral tablets with 450 mg of Phosphatidylcholine chaperone alone for a period of 6 months twice daily.
Control group
Active

Outcomes
Primary outcome [1] 294268 0
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.
Timepoint [1] 294268 0
End of 6th month of interventional period.
Primary outcome [2] 294668 0
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}.
Timepoint [2] 294668 0
End of the 6th month of interventional period
Secondary outcome [1] 312913 0
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.
Timepoint [1] 312913 0
end of 4th and 6th months of interventional time period.
Secondary outcome [2] 313837 0
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.
Timepoint [2] 313837 0
end of 4th and 6th months of interventional time period.
Secondary outcome [3] 313838 0
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.
Timepoint [3] 313838 0
end of 4th and 6th months of interventional time period.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Medical personal of outpatient clinic of the Institute of Immunology UzAS will be informed about launching the trial, its major goal and selection criteria for volunteers. Suitable individuals will be invited for preliminary check-up (physical and laboratory investigation) during the initial phase of enrollment. All suitable individuals will be re-screened after wash-out period of the trail before final decision on trial enrollment is made.
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization of volunteers in the trial will be performed using widely accepted methods such as simple randomization and stratified randomization. Briefly, the software containing random number generator will be applied to database of the volunteers. They assigned group will be considered as a final. The groups will be balanced according to numerical age and gender with special software. Stratified randomization will be used to enhance statistical power of the final results and will ensure equality of groups in secondary selection criteria.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
None
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis of results will be performed by independent statistician. If statistical methods as well as the statistical settings listed above will be not appropriate for newly obtained results due to specificity of variant distribution, other methods of statistical analysis will be applied. Any deviations from the statistical plan described above will be explained and justified in a protocol amendment and/or in the final report submitted to the Institutional Ethics Committee.
Sample size determination for the study groups was based on the results of a pilot clinical trial. It was determined that according to the values of standard deviation the required number of patients in each group is 30 patients. The actual size of groups was set at 40 patients per group due to drop-outs.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/02/2015
Actual
4/03/2015
Date of last participant enrolment
Anticipated
5/08/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 6652 0
United Kingdom
State/province [1] 6652 0
Cambridge
Country [2] 6653 0
Uzbekistan
State/province [2] 6653 0
Tashkent

Funding & Sponsors
Funding source category [1] 290728 0
Commercial sector/Industry
Name [1] 290728 0
Lycotec Ltd
Country [1] 290728 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
Name
Lycotec Ltd, Cambridge, UK
Address
Platinum Building, Granta Park, Cambridge, CB21 6GP.
Country
United Kingdom
Secondary sponsor category [1] 289418 0
Commercial sector/Industry
Name [1] 289418 0
NUTRA Sp. Z.o.o.
Address [1] 289418 0
Ul. Rydygiera 8 building 3A
01-791 Warsaw, Poland
Country [1] 289418 0
Poland
Other collaborator category [1] 278345 0
Government body
Name [1] 278345 0
Institute of Immunology UzAS
Address [1] 278345 0
Y.Gulomov str. 74, Tashkent, Uzbekistan
Country [1] 278345 0
Uzbekistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292364 0
Institutional review board
Ethics committee address [1] 292364 0
Ethics committee country [1] 292364 0
Uzbekistan
Date submitted for ethics approval [1] 292364 0
03/01/2015
Approval date [1] 292364 0
04/02/2015
Ethics approval number [1] 292364 0
122-74/32

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53942 0
Dr Malika R Ruzibakieva
Address 53942 0
Institute of Immunology UzAS, Y.Gulomov str. 74, Tashkent, Uzbekistan
Country 53942 0
Uzbekistan
Phone 53942 0
+998712330855
Fax 53942 0
Email 53942 0
[email protected]
Contact person for public queries
Name 53943 0
Ivan M Petyaev MD, PhD
Address 53943 0
Lycotec Ltd, Granta Park, Cambridge, CB21 6GP, United Kingdom.
Country 53943 0
United Kingdom
Phone 53943 0
(44) -1223-42-721
Fax 53943 0
(44)-1223-42-72
Email 53943 0
[email protected]
Contact person for scientific queries
Name 53944 0
Yuriy K Bashmakov MD, PhD
Address 53944 0
Lycotec Ltd, Granta Park, Cambridge, CB21 6GP, United Kingdom.
Country 53944 0
United Kingdom
Phone 53944 0
(44) -1223-42-72
Fax 53944 0
(44)-1223-42-72.
Email 53944 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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