"Real Life" Evaluation of Efficacy and Safety of Direct Antiviral Agents (DAAs) for the Treatment… (NCT03510637) | Clinical Trial Compass
UnknownNot Applicable
"Real Life" Evaluation of Efficacy and Safety of Direct Antiviral Agents (DAAs) for the Treatment of Hepatitis C Virus in Egypt
Egypt7,500 participantsStarted 2018-01-22
Plain-language summary
The primary purpose of the ANRS 12332 HepNile study cohort is to assess in "Real-Life" condition the efficacy and the safety profile of new Direct Acting Antivirals (DAAs) introduced in the Egyptian National Treatment Programme for the treatment of Chronic Hepatitis C (CHC).
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* HCV RNA positivity
* 18 years =\< Age =\< 70 years
* Patients \>= 65 years should undergo cardiological assessment prior to therapy by ECG echocardiography and cardiological consultation
* Effective contraception (Women of childbearing potential should use an effective contraception; Male patients and their female partners must also practice effective contraception) both during treatment and for the 3-months post-therapy); no breast-feeding
* Signed informed consent and willingness to participate in the study
Exclusion Criteria:
* Child C cirrhotic patients
* Platelet count \> 50000/mm3
* Hepatocellular Carcinoma (HCC), except 6 months after intervention aiming at cure with no evidence of activity by dynamic imaging (CT or MRI)
* Extra-hepatic malignancy except after two years of disease-free interval (in case of lymphomas and chronic lymphatic leukemia, treatment can be initiated immediately after remission)
* Pregnancy or inability to use effective contraception
* inadequately controlled diabetes mellitus (HbA1C\>9%)
What they're measuring
1
Sustained Virological Response 12 weeks after the end of treatment (SVR12)
Timeframe: Post-treatment Week 12 (Week 24 or Week 36)