CirrhosisPhase 2/3IMUNO-HEGITO7NCT02837939
Transfer Factor Efficacy in the Management of Cirrhosis-associated Immune Dysfunction
A Phase 2/3 study testing Human derived Transfer factor and Aqua pro injectione 4ml ampules for subcutaneous injection in people with Cirrhosis and Liver Failure, run by Martin Janičko at 1 site in Slovakia.
Trial summary
This study is aimed to assess the efficacy of Human derived Transfer factor ( T-lymphocytes homogenate that contains small molecular weight (10 kDa) molecules: various IFNs, ILs, chemokines, endorfins, heat shock proteins) in decreasing rate and/or severity of infections in acute or chronic decompensations of liver… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Liver Failure
- What is being tested?
- Human derived Transfer factor and Aqua pro injectione 4ml ampules for subcutaneous injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSlovakia
- Study dates
- Jul 2016to Jul 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- admission to hospital at participating liver units or ICUs or internal medicine wards with acute decompensation (AD) of advanced chronic liver disease or acute-on-chronic liver failure according to CLIF - C criteria
- ability to provide informed consent,
Who cannot join
- disapproval
- lymphoproliferative disorders
- liver transplantation in the past
- pregnancy
- suspected. chronic infection in risk locations
- CNS
Show all 11Show fewer
- peritoneum
- Known virus-related immune deficiency
- malignancy
- severe heart failure (NYHA >= III)
- severe lung disease (COPD, GOLD>3)
Trial locations and contacts
1 site in 1 country.
Slovakia1 site
F.D.Roosevelt Teaching Hospital with policlinic Banska Bystrica
Banská Bystrica, 97517
About this study
Official title: Prospective Randomized Single-blind Study on Transfer-factor in Acute Decompensation of Advanced Chronic Liver Disease and Acute-on-chronic Liver Failure.
This study is aimed to assess the efficacy of Human derived Transfer factor ( T-lymphocytes homogenate that contains small molecular weight (10 kDa) molecules: various IFNs, ILs, chemokines, endorfins, heat shock proteins) in decreasing rate and/or severity of infections in acute or chronic decompensations of liver cirrhosis and acute on chronic liver failure..
Read the detailed description
Most of mortality from advanced chronic liver disease (ACLD) is mediated by so- called specific complications of end-stage liver disease (ESLD); one of the most important is infection (25-30%). Infection is responsible for considerable proportion of ESLD-related mortality. Important in pathogenesis of infections in ESLD is CAIDS (cirrhosis - associated immune dysfunction syndrome), recently re-named to CAID (Cirrhosis-Associated Immune Deficit). TRANSFER FACTOR (TF) is supposed to act at several points in CAID - cascade. This gave rise to hypothesis, that TF could be of benefit in AD/ACLF.
Characteristics of TF It has been shown that transmission fo T-Lymphocyte reactivity is transmissible not only by T-cells alone, but also by hommogenate of peripheral white blood cells. Later it became clear that for the transmission of cellular immunity is responsible dialysable fraction of T-lymphocytes homogenate (with small molecular weight of 10 kDa; consists of amino acids, small peptides, nucleotides etc). This homogenate was named Transfer - factor (TF). One dose of lyophilized drug contains: Leucocyti dialysatum 200 x 10 6 (contains various IFNs, ILs, chemokines, endorfins, heat shock protein etc)
- stimulates T H 1 response
- induces production of IL-1, IL-2
- activates chemotaxis of immunocompetent cells
- increases fagocytic activity
- activates antigen-presentation by APCs
The aim of this study is to assess the efficacy of transfer factor in decreasing rate and/or severity of infections in ACLF.
- Conditions
- Cirrhosis, Liver Failure
- Being tested
- Human derived Transfer factor, Aqua pro injectione 4ml ampules for subcutaneous injection
- Medical subject headings
- Fibrosis, Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human derived Transfer factorDrug
Also called IMMODIN. Holder: IMUNA PHARM a.s. - GRIFOLS (SVK) Registration number: 59/0147/89-CS
One dose (the content of one amp.) of lyophilised drug contains:
Leucocyte dialysatum 200 x 10 to the power of 6 (Lyophilized dialysate from 200 million leukocytes) pH = 7.8 to 9 after reconstitution (dissolving) of drug
To be administered subcutaneously as follows:
12 doses TF in total:
- 3 x TF in first week: day 1,3,5
- 2 x TF in week 2: day 8 , 11
- 1 xTF in week 3 and 4 : day 15, 22
- 1 x TF once a month up to 6 month
Aqua pro injectione 4ml ampules for subcutaneous injectionDrug
12 doses in total:
- 3 doses in first week: day 1,3,5
- 2 doses in week 2: day 8 , 11
- 1 dose in week 3 and 4 : day 15, 22
- 1 dose once a month up to 6 month
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Drug: Human derived Transfer factor applied by subcutaneous injection in specified time points. Receives: Drug: Human derived Transfer factor |
| Control | Placebo comparator | Aqua pro injectione 4 mL ampules for subcutaneous administration in the same time points as in the active arm Receives: Drug: Aqua pro injectione 4ml ampules for subcutaneous injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint that includes the incidence specified infections:
- Spontaneous bacterial peritonitis
- Urinary tract infections:
- Pneumonia
- Skin and soft tissue infections
- Spontaneous bacteremia
- Endocarditis
- Tuberculosis
- Infectious colitis
Measured: Two years
Secondary outcomes (3)
Length of hospital stay
The length of hospital stay after the admission with diagnosed infection or contraction of infection during hospital stay
Measured: Two years
The usage of antibiotics required for treatment of a diagnosed infection
Measured: Two years
The incidence of adverse effects
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin Janičko
- Sponsor type
- University, hospital or other
- Collaborators
- F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
- Responsible party
- Sponsor-investigator, Martin Janičko, Pavol Jozef Safarik University
- Investigators
- Lubomir Skladany, MD, PhD, Principal investigator, F.D.Roosevelt Teaching Hospital with policlinic, Banska Bystrica, Slovakia, 97517
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837939
- Sponsor's protocol ID
- IMUNO - HEGITO 7
- Acronym
- IMUNO-HEGITO7
- Status last verified
- Nov 2023
- First submitted
- 13 Jul 2016
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Single-blind Study on Transfer-factor in Acute Decompensation of Advanced Chronic Liver Disease and Acute-on-chronic Liver Failure.
- ClinicalTrials.gov ID
- NCT02837939
- Acronym / sponsor ID
- IMUNO-HEGITO7 / IMUNO - HEGITO 7
- Conditions
- Cirrhosis, Liver Failure
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Martin JaničkoUniversity, hospital or other
- Collaborators
- F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
- Study start
- Jul 2016
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 20 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is aimed to assess the efficacy of Human derived Transfer factor ( T-lymphocytes homogenate that contains small molecular weight (10 kDa) molecules: various IFNs, ILs, chemokines, endorfins, heat shock proteins) in decreasing rate and/or severity of infections in acute or chronic decompensations of liver cirrhosis and acute on chronic liver failure..
Detailed description
Most of mortality from advanced chronic liver disease (ACLD) is mediated by so- called specific complications of end-stage liver disease (ESLD); one of the most important is infection (25-30%). Infection is responsible for considerable proportion of ESLD-related mortality. Important in pathogenesis of infections in ESLD is CAIDS (cirrhosis - associated immune dysfunction syndrome), recently re-named to CAID (Cirrhosis-Associated Immune Deficit). TRANSFER FACTOR (TF) is supposed to act at several points in CAID - cascade. This gave rise to hypothesis, that TF could be of benefit in AD/ACLF.
Characteristics of TF It has been shown that transmission fo T-Lymphocyte reactivity is transmissible not only by T-cells alone, but also by hommogenate of peripheral white blood cells. Later it became clear that for the transmission of cellular immunity is responsible dialysable fraction of T-lymphocytes homogenate (with small molecular weight of 10 kDa; consists of amino acids, small peptides, nucleotides etc). This homogenate was named Transfer - factor (TF). One dose of lyophilized drug contains: Leucocyti dialysatum 200 x 10 6 (contains various IFNs, ILs, chemokines, endorfins, heat shock protein etc)
- stimulates T H 1 response
- induces production of IL-1, IL-2
- activates chemotaxis of immunocompetent cells
- increases fagocytic activity
- activates antigen-presentation by APCs
The aim of this study is to assess the efficacy of transfer factor in decreasing rate and/or severity of infections in ACLF.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: Human derived Transfer factorDrug: Human derived Transfer factor applied by subcutaneous injection in specified time points. |
| Control | Placebo comparator | Drug: Aqua pro injectione 4ml ampules for subcutaneous injectionAqua pro injectione 4 mL ampules for subcutaneous administration in the same time points as in the active arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- admission to hospital at participating liver units or ICUs or internal medicine wards with acute decompensation (AD) of advanced chronic liver disease or acute-on-chronic liver failure according to CLIF - C criteria
- ability to provide informed consent,
Key exclusion criteria (11 listed)
- disapproval
- lymphoproliferative disorders
- liver transplantation in the past
- pregnancy
- suspected. chronic infection in risk locations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human derived Transfer factorAlso: IMMODIN. Holder: IMUNA PHARM a.s. - GRIFOLS (SVK) Registration number: 59/0147/89-CSOne dose (the content of one amp.) of lyophilised drug contains: Leucocyte dialysatum 200 x 10 to the power of 6 (Lyophilized dialysate from 200 million leukocytes) pH = 7.8 to 9 after reconstitution (dissolving) of drug To be administered subcutaneously as follows: 12 doses TF in total: * 3 x TF in first week: day 1,3,5 * 2 x TF in week 2: day 8 , 11 * 1 xTF in week 3 and 4 : day 15, 22 * 1 x TF once a month up to 6 month | Drug | Active |
| Aqua pro injectione 4ml ampules for subcutaneous injection12 doses in total: * 3 doses in first week: day 1,3,5 * 2 doses in week 2: day 8 , 11 * 1 dose in week 3 and 4 : day 15, 22 * 1 dose once a month up to 6 month | Drug | Control |
Primary outcome
Composite endpoint that includes the incidence specified infections:
Time frame: Two years
1. Spontaneous bacterial peritonitis 2. Urinary tract infections: 3. Pneumonia 4. Skin and soft tissue infections 5. Spontaneous bacteremia 6. Endocarditis 7. Tuberculosis 8. Infectious colitis
3 secondary outcomes
Length of hospital stay
Time frame: Two years
The usage of antibiotics required for treatment of a diagnosed infection
Time frame: Two years
The incidence of adverse effects
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lubomir Skladany, MD, PhD principal investigator
F.D.Roosevelt Teaching Hospital with policlinic, Banska Bystrica, Slovakia, 97517
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Human derived Transfer factor and Aqua pro injectione 4ml ampules for subcutaneous injection in people with Cirrhosis and Liver Failure, run by Martin Janičko at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint that includes the incidence specified infections: (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.