Hematologic Profile, Vit. B12 and Folic Acid in Cirrhotics Received Sofosbuvir and Daclatasvir With or Without Ribavirin

October 14, 2020 updated by: Mohammed Shaaban Redwan Helal, Assiut University

Changes in Hematologic Profile, Vitamin B12 and Folic Acid Level in Cirrhotic Patients Received Sofosbuvir and Daclatasvir With or Without Ribavirin

Use of Ribavirin could affect hematologic profile of the patients negatively. With advent of new antiviral therapy, the preexisting hematologic changes may alter or corrected after treatment. However, this point is still not properly studied.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hepatitis C virus (HCV) infection is a global health problem that affects 170 million people worldwide, and approximately 55% (95 million) of the infected population is in South East Asia and Western Pacific countries.

Hepatitis C virus (HCV) is considered one of the main causes of chronic hepatitis and also may be complicated by serious complications as liver cirrhosis, ascites and hepatocellular carcinoma. It is also, one of the leading indications for liver transplantation (LT) in adults around the world.

Abnormalities in hematological parameters are common in patients with cirrhosis. The pathogenesis of abnormal hematological indices (HIs) in cirrhosis is multifactorial and includes portal hypertension-induced sequestration, alterations in bone marrow stimulating factors, viral- and toxin-induced bone marrow suppression and consumption or loss. Abnormalities in HIs are associated with an increased risk of complications including bleeding and infection.

So, early recognition and early treatment of those patients with chronic HCV infection can modify its natural history. There are many factors affecting the outcome of HCV infection as viral, environmental and host factors, including immunologic and genetic susceptibilities.

Till 2011, the main lines of therapy were Interferon plus ribavirin for at least 48 weeks but these combinations was associated with low incidence of Sustained Virological Response (SVR). Now, there is era of Direct Acting Analogues that used for treatment of patients with chronic HCV infection and associated with high rate of SVR.

Daclatasvir is a first-in-class HCV NS5A replication complex inhibitor, and Sofosbuvir is a nucleotide analogue HCV NS5B polymerase inhibitor. Both have potent antiviral activity and broad genotypic coverage and are administered orally once daily.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71111
        • Mohamed Shaban Redwan Helal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Fifty patients were diagnosed to have HCV-related liver cirrhosis and candidate for anti- HCV therapy

Description

Inclusion Criteria:

  • Patients known to have HCV-related liver cirrhosis and candidate for therapy with Sofosbuvir and Daclatasvir with or without Ribavirin

Exclusion Criteria:

  • Chronic hepatitis due causes other than chronic HCV infection
  • Coinfection with HIV or HBV infection
  • Hepatocellular carcinoma
  • Decompensated cirrhosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sofo-Dacla with Ribavirin
Chronic Hepatitis C related Liver Cirrhosis patients who will take sofosbuveir, Daclatasvir with Ribavirin
Diagnostic test: Vitamin B12 and Folic Acid
Vitamin B12 and Folic Acid measurement by ELISA technique
Sofo-Dacla without Ribavirin
Chronic Hepatitis C related Liver Cirrhosis patients who will take sofosbuveir, Daclatasvir without Ribavirin
Diagnostic test: Vitamin B12 and Folic Acid
Vitamin B12 and Folic Acid measurement by ELISA technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vitamin B12
Time Frame: 1 year
By ELISA Technique, in Pg/ml
1 year
Folic Acid
Time Frame: 1 year
By ELISA technique, in Pg/ml
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

January 14, 2020

Study Registration Dates

First Submitted

September 12, 2017

First Submitted That Met QC Criteria

September 12, 2017

First Posted (Actual)

September 14, 2017

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 14, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Haematological Prof. in DAAs

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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