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

Sponsor

Assiut University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03163849

Collaborator

(none)

Enrollment

Locations

Arms

10.9

Anticipated Duration (Months)

Patients Per Site

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis c	Drug: Sofosbuvir , daclatasvir Drug: Placebos	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2019

Anticipated Primary Completion Date :

Jun 1, 2020

Anticipated Study Completion Date :

Jul 30, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Placebo Comparator: control group

oral tablets

Drug: Placebos

oral tablets

Experimental: Study group

sofosbuvir , daclatasvir oral tablets

Drug: Sofosbuvir , daclatasvir

Tablets

Outcome Measures

Primary Outcome Measures

the percentage of patients with hematological changes [12 weeks]
complete blood count and prothrombin time and concentration
The percentage of patients with antibodies against RBCs [Pre treatment]
Coomb's test

Secondary Outcome Measures

the percentage of patients with biochemical changes [12 weeks]
Urea, creatinine,bilirubin,ALT,AST
The percentage of patients with antibodies against RBCs [Three months after the end of treatment]
Coomb's test

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)