Assessment Effects After Direct Acting Antiviral in Chronic Hepatitis c Virus Patients

September 10, 2019 updated by: Sahar Ezeldeen Hussein Ali, Assiut University

Assessment of Haematological and Biochemical Effect After New Direct Acting Antiviral Drugs in Chronic Hepatitis c Virus Egyptian Patients in Assiut Province

Chronic hepatitis C virus infection affects an estimated one hundred and seventy million people around the world with and approximate prevalence 0.2-2 % in the United State of America and European countries.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In Egypt, Chronic hepatitis C virus is a serious health problem where Chronic hepatitis C virus prevalence is very high.

Chronic Chronic hepatitis C virus infection is associated with a high risk for liver-related mortality because of a variety of complications, which appear obviously in those patients with developing end-stage liver disease, including decompensated liver cirrhosis and hepatocellular carcinoma. Egypt had the highest burden of deaths from Chronic hepatitis C virus-associated hepatocellular carcinoma in the Arab world, around sixty three percentage of all Chronic hepatitis C virus-associated hepatocellular carcinoma deaths happened in Egypt.

Poor response rates and poor tolerability were observed during treatment of chronic Chronic hepatitis C virus infection with pegylated interferon and ribavirin.

Because Chronic hepatitis C virus does not incorporate into the human genome and must replicate to maintain infection, it should be potential to destroy the virus completely by blocking replication at one or more stages of the life cycle.

In recent years, there has been a shift in treatment paradigm with the discovery and approval of agents that target specific proteins vital for hepatitis C replication. The Non Structural 3/4A inhibitors simeprevir and paritaprevir, the NonStructural 5A inhibitors ombitasvir, ledipasvir, and daclatasvir, and the Non Structural 5B inhibitors sofosbuvir and dasabuvir have been approved and incorporated as first-line agents into the latest guidelines for Hepatitis C treatment. Used in combination, these agents produce higher rates of sustained virologic response and less adverse effects than historical options, along with limited rates of resistance.

In previous studies ,haematological side effect of interferon and Ribavirin was reported in the form of reduction in Haemoglobin ,White Blood Cells and asymptomatic thrombocytopenia While SOF based combination therapy improved the liver function, anemia ,leucopenia and thrombocytopenia were detected especially after treatment with SOF,RBV and PegINF alpha .also significant improvement in the level of ALT and AST post treatment with either SOF and RBV or SOF ,RBV and INF were detected as compaired to baseline While no significant differences were detected on the level of total bilirubin or creatinine In our study we will assess and evaluate many biochemical and hematological findings upon new direct acting antiviral agents in Egyptian chronic hepatitis C virus patients

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 3

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
      • Assuit, Egypt
        • ASSUIT
    • Assuit
      • Assiut, Assuit, Egypt
        • ASSUIT

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Our study proposed for all consented patients complaining from chronic Hepatitis C virus infection undergoing treatment with antiviral drugs is possible through certain indications or criteria as follow:
  • Patients with chronic Hepatitis C virus who are candidates for Direct Acting Antiviral Therapy:
  • Age is from 18 to 65 years.

Exclusion Criteria:

  • Those patients with chronic Hepatitis C virus infection are impossible or contraindicated to be treated with antiviral drugs as follow: - Geriatrics (> 65 years of age): - Pediatrics (< 18 years of age): - patients with known hypersensitivity to any of the components of the antiviral drug.
  • Post-Liver Transplant Patients. ـPatients with primary haematological abnormalities not related to chronic hepatitis C virus infection
  • Experienced patients (previously failed treatment)

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: control group
oral tablets
Drug: Placebos
oral tablets
Experimental: Study group
sofosbuvir , daclatasvir oral tablets
Drug: Sofosbuvir , daclatasvir
Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the percentage of patients with hematological changes
Time Frame: 12 weeks
complete blood count and prothrombin time and concentration
12 weeks
The percentage of patients with antibodies against RBCs
Time Frame: Pre treatment
Coomb's test
Pre treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the percentage of patients with biochemical changes
Time Frame: 12 weeks
Urea, creatinine,bilirubin,ALT,AST
12 weeks
The percentage of patients with antibodies against RBCs
Time Frame: Three months after the end of treatment
Coomb's test
Three months after the end of treatment

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Principal Investigator: Sahar Ali, Master Degree, Internal medicine

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)

September 1, 2019

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

July 30, 2020

Study Registration Dates

First Submitted

May 18, 2017

First Submitted That Met QC Criteria

May 22, 2017

First Posted (Actual)

May 23, 2017

Study Record Updates

Last Update Posted (Actual)

September 12, 2019

Last Update Submitted That Met QC Criteria

September 10, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRHCV

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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