Study the Content of the HBV DNA in Liver Biopsy in the Patients Chronic Hepatitis Delta

NCT04170452 | Unknown DMC

• 1 other identifier: ADCC - 15.21.1
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Study the content of the HBV DNA in liver biopsy in the patients with the Chronic Hepatitis Delta in absence of the HBV DNA in the blood plasma

Conditions

Chronic Hepatitis Delta; Liver Biopsy

Keywords

Viral hepatitis B; HBV DNA; Viral hepatitis Delta; iver biopsy; PCR

Outcome Measures

Primary Outcomes (1)

• The study the content of the HBV DNA in liver biopsy

  In this study we are going to do liver biopsy in 30 patients with a diagnosis of Chronic Viral Hepatitis B and Delta.

  up to 3 months

Study Arms (1)

Chronic Hepatitis Delta patients

Patients infected with delta virus

Procedure: liver biopsy

Interventions

liver biopsy PROCEDURE

Pre-procedure assessment of the liver with ultrasound should be performed for planning positioning and needle entrance point. Supine, oblique, or total left lateral decubitus are the possible positioning of the patient - it is important to make sure that the patient is comfortable and can remain still in that position. Assessing if the procedure will be performed under breath held and practice this with the patient. Marking of the entrance point on the skin is advised to aid the skin cleaning and dressing. A time-out should be performed by this stage. Skin site is prepped and draped to ensure asepsis. Ocal anaesthesia is infiltrated under the skin abdominal wall/intercostal space until the liver capsule. Entrance point is created with a scalpel. Using the freehand technique the needle is advanced under ultrasound guidance during the entire course of the biopsy. The needle tip must always cross the capsule prior to deploying the cutting device.

Chronic Hepatitis Delta patients

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

All patients with chronic viral hepatitis delta

You may qualify if:

• patients with the Chronic Hepatitis Delta in absence of the HBV DNA in the blood plasma

You may not qualify if:

• patient's with the Chronic Hepatitis Delta in absence of the HBV DNA in the blood plasma but: inability to remain still and to maintain brief expiration for the procedure, suspected vascular lesion (eg, hemangioma), bleeding tendency (eg, INR \> 1.2 despite receiving vitamin K, bleeding time \> 10 min), severe thrombocytopenia (\< 50,000/mL)

Sponsors & Collaborators

• Tokhirbek Dolimov: lead

Study Sites (1)

RIEMID

Tashkent, Uchtepa District,, 100106, Uzbekistan

Location

Biospecimen

Retention: SAMPLES WITH DNA

Detection of DNA HBV in liver cells

MeSH Terms

Conditions

Hepatitis D, Chronic; Hepatitis B

Condition Hierarchy (Ancestors)

Hepatitis D; Hepatitis, Viral, Human; Virus Diseases; Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections

Study Officials

• Nariman Gulyamov, DSci

  Research institute of epidemiology, microbiology and infectious diseases

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Institute of Epidemiology, Microbiology and Infectious deseases

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: November 20, 2019
• Study Start: October 10, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: November 21, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

UZ (1)