Evaluation of the National Treatment Program of Hepatitis C in Egypt

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-12-31

Brief Summary

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The aim of the study is to analyse data coming from two treatment centres of the National Treatment Program Centres of hepatitis C in Egypt

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Detailed Description

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Analyse data coming from two centres of the National Treatment Program of hepatitis C in Egypt:

* 1500 patients who started treatment between April 1st 2013 and March 31st 2014 and will be seen for their week 60 visit between July 1st 2014 and June 30th 2015 (Cohort A).
* 1000 patients recruited between July 1st 2014 and estimated March 31st 2015, of which 200 are expected to be early defaulters and will be contacted by the study team (Cohort B).

Conditions

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Chronic Hepatitis C

Study Design

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Observational Model Type

COHORT

Study Groups

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Patients under Dual therapy

\- 1500 patients who started treatment between April 1st 2013 and March 31st 2014 and will be seen for their week 60 visit between July 1st 2014 and June 30th 2015 (Cohort A).

No interventions assigned to this group

Early Defaulters

\- 1000 patients recruited between July 1st 2014 and estimated March 31st 2015, of which 200 are expected to be early defaulters and will be contacted by the study team (Cohort B).

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age \< 18 years and \> 60 years
* Positive HCV antibodies using a third generation test
* Detectable HCV RNA by PCR
* Liver biopsy showing chronic hepatitis with either a METAVIR score F1 with elevated liver enzymes or scores F2/F3
* Naïve to treatment with PEG-IFN and RBV
* HBs antigen negative
* Prothrombin time ≥60 %, normal bilirubin, alpha-foeto protein \< 3\*normal range of the laboratory, anti-nuclear antibodies\<1/160
* Effective contraception during the treatment period; no breast-feeding
* Signed informed consent and willingness to participate in the study

Exclusion Criteria

* Serious co-morbid conditions such as severe hypertension, heart failure, significant coronary heart disease, poorly controlled diabetes (HbA1C\>8%) , chronic obstructive pulmonary disease
* Major uncontrolled depressive illness
* Solid transplant organ (renal, heart, or lung)
* Untreated thyroid disease
* History of previous anti-HCV therapy
* Body mass index (BMI) greater than 30 kg/m²
* Known human immunodeficiency virus (HIV) coinfection: although HIV testing will not be proposed or done, patients with known HIV coinfection will not be included in the trial
* hypersensitivity to one of the two drugs (PEG-IFN, RBV)
* pregnancy or unwilling to comply with adequate contraception
* breast-feeding
* neutropenia (\<1500/mm3)
* anaemia (\<11g/dL for women ; \<12g/dL for men)
* thrombocytopenia (\<100.000/mm3)
* elevated creatinin (\>1.5mg/dL)
* concomitant liver disease other than hepatitis C (immuno-active chronic hepatitis B, autoimmune hepatitis, alcoholic liver disease, hemochromatosis, alpha-1 antitrypsin deficiency, Wilson disease)
* liver biopsy showing severe steatosis (\>66%) and steatohepatitis; decompensated cirrhosis (Child Pugh\>A); hepatocellular carcinoma, METAVIR score F4.
* TSH\>5 mU/L

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No