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Transfer Factor Efficacy in the Management of Cirrhosis-associated Immune Dysfunction

NCT02837939 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2023-11-18

No results posted yet for this study

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..

Conditions

  • Cirrhosis
  • Liver Failure

Interventions

DRUG

Human derived Transfer factor

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

DRUG

Aqua pro injectione 4ml ampules for subcutaneous injection

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

Sponsors & Collaborators

  • F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

    collaborator OTHER

  • Martin Janičko

    lead OTHER

Principal Investigators

  • Lubomir Skladany, MD, PhD · F.D.Roosevelt Teaching Hospital with policlinic, Banska Bystrica, Slovakia, 97517

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • Slovakia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02837939 on ClinicalTrials.gov