NCT02837939

Brief 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 cirrhosis and acute on chronic liver failure..

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2016

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

9 years

First QC Date

July 13, 2016

Last Update Submit

November 15, 2023

Conditions

CirrhosisLiver Failure

Outcome Measures

Primary Outcomes (1)

  • Composite endpoint that includes the incidence specified infections:

    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

    Two years

Secondary Outcomes (3)

  • Length of hospital stay

    Two years

  • The usage of antibiotics required for treatment of a diagnosed infection

    Two years

  • The incidence of adverse effects

    2 years

Other Outcomes (6)

  • Change in the phagocytic activity of macrophages

    6 months

  • Changes in the levels of imunoglobulins IgA, IgG, IgM, IgD, IgE

    6 months

  • Changes in the capacity for oxidative burst in macrophages

    6 months

  • +3 more other outcomes

Study Arms (2)

Active

EXPERIMENTAL

Drug: Human derived Transfer factor applied by subcutaneous injection in specified time points.

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

Drug: Aqua pro injectione 4ml ampules for subcutaneous injection

Interventions

Human derived Transfer factorDRUG

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

Also known as: IMMODIN. Holder: IMUNA PHARM a.s. - GRIFOLS (SVK) Registration number: 59/0147/89-CS
Active
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

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

  • disapproval
  • lymphoproliferative disorders
  • liver transplantation in the past
  • pregnancy
  • suspected. chronic infection in risk locations
  • CNS
  • peritoneum
  • Known virus-related immune deficiency
  • malignancy
  • severe heart failure (NYHA \>= III)
  • severe lung disease (COPD, GOLD\>3)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

F.D.Roosevelt Teaching Hospital with policlinic Banska Bystrica

Banská Bystrica, 97517, Slovakia

Location

MeSH Terms

Conditions

FibrosisLiver Failure

Interventions

Injections, Subcutaneous

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

InjectionsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Lubomir Skladany, MD, PhD

    F.D.Roosevelt Teaching Hospital with policlinic, Banska Bystrica, Slovakia, 97517

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Medicine, Faculty of Medicine

Study Record Dates

First Submitted

July 13, 2016

First Posted

July 20, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations

SL(1)