"Real Life" Evaluation of Efficacy and Safety of Direct Antiviral Agents (DAAs) for the Treatment of Hepatitis C Virus in Egypt
HepNile
ANRS 12332 HepNile : Evaluation of "Real Life" Efficacy and Safety of Antiviral Treatments Including New Direct Antiviral Agents Among Patients Treated for Chronic Hepatitis C (CHC) in Three National Treatment Centres in Cairo
1 other identifier
observational
7,500
1 country
3
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2018
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 22, 2018
CompletedFirst Submitted
Initial submission to the registry
April 13, 2018
CompletedFirst Posted
Study publicly available on registry
April 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedJuly 29, 2019
July 1, 2019
2.5 years
April 13, 2018
July 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sustained Virological Response 12 weeks after the end of treatment (SVR12)
Efficacy of treatment given by the proportion of patients with an HCV RNA undetectable 12 weeks after the completion of treatment.
Post-treatment Week 12 (Week 24 or Week 36)
Secondary Outcomes (3)
Proportion of patients with adverse reactions/events leading to dosage reduction and/or treatment discontinuation
End of Treatment Week 12 or Week 24
Adherence to treatment strategy
Post-treatment Week 12 (Week 24 or Week 36)
Resistance-Associated Variants (RAVs)
Post-Treatment Week 12 (Week 24 or Week 36)
Eligibility Criteria
Patients with a Chronic Hepatitis C and with prior approval from the Ministry of Health to begin HCV therapy
You may qualify if:
- HCV RNA positivity
- 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
You may not qualify if:
- 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%)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ANRS, Emerging Infectious Diseaseslead
- Institut Pasteurcollaborator
Study Sites (3)
El Fatemia El Kahera Centre
Cairo, Egypt
National Hepatology and Tropical Medicine Institute
Cairo, Egypt
New Cairo Hospital
Cairo, Egypt
Related Publications (3)
Esmat G, El Kassas M, Hassany M, Gamil ME, El Raziky M. How to optimize HCV therapy in genotype 4 patients. Liver Int. 2013 Feb;33 Suppl 1:41-5. doi: 10.1111/liv.12059.
PMID: 23286845BACKGROUNDDoss W, Shiha G, Hassany M, Soliman R, Fouad R, Khairy M, Samir W, Hammad R, Kersey K, Jiang D, Doehle B, Knox SJ, Massetto B, McHutchison JG, Esmat G. Sofosbuvir plus ribavirin for treating Egyptian patients with hepatitis C genotype 4. J Hepatol. 2015 Sep;63(3):581-5. doi: 10.1016/j.jhep.2015.04.023. Epub 2015 May 1.
PMID: 25937436BACKGROUNDObach D, Yazdanpanah Y, Esmat G, Avihingsanon A, Dewedar S, Durier N, Attia A, Anwar WA, Cousien A, Tangkijvanich P, Eholie SP, Doss W, Mostafa A, Fontanet A, Mohamed MK, Deuffic-Burban S. How to optimize hepatitis C virus treatment impact on life years saved in resource-constrained countries. Hepatology. 2015 Jul;62(1):31-9. doi: 10.1002/hep.27691. Epub 2015 Feb 27.
PMID: 25581111BACKGROUND
Related Links
Biospecimen
Blood sample (15 mL): * at inclusion, * at the End of Treatment (EOT) * 12 weeks after the end of treatment (only for patients who do not achieve a SVR). Samples (serum, plasma, DNA) stored in a dedicated biobank
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yehia Mohamed El Sayed El Shazly, MD
Ain Shams University
- PRINCIPAL INVESTIGATOR
Arnaud Fontanet, MD, PhD
Institut Pasteur
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2018
First Posted
April 27, 2018
Study Start
January 22, 2018
Primary Completion
August 1, 2020
Study Completion
August 1, 2020
Last Updated
July 29, 2019
Record last verified: 2019-07