Chronic Hepatitis CHepNileNCT03510637
"Real Life" Evaluation of Efficacy and Safety of Direct Antiviral Agents (DAAs) for the Treatment of Hepatitis C Virus in Egypt
An observational study of Chronic Hepatitis C, run by ANRS, Emerging Infectious Diseases at 3 sites in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis C
- How many people
- 7,500 participants
- Where
- 3 sitesEgypt
- Study dates
- 22 Jan 2018to Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a Chronic Hepatitis C and with prior approval from the Ministry of Health to begin HCV therapy
Who may be able to join
- 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
Who cannot join
- 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%)
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites, 3 recruiting
- Recruiting
El Fatemia El Kahera Centre
Cairo
- Recruiting
National Hepatology and Tropical Medicine Institute
Cairo
- Recruiting
New Cairo Hospital
Cairo
About this study
Official title: 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
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).
Read the detailed description
Clinical trials are performed under optimal conditions where patients are highly selected with no co-morbidity, clinical supervision is provided by the best specialists in the field, and strict protocols are used to enhance patients' compliance. Thus, results may not be generalizable to real-world clinical practice.
Observational studies are now gaining attention, showing with previous treatments (combined pegylated interferon and ribavirin) a wide range of results in terms of treatment effectiveness (SVR from 21% to 63% overall), whereas related pivotal clinical trials had estimated SVRs between 54% and 63% overall.
Egypt is the first low/middle-income country where a national treatment program has been established on a large scale, allowing an evaluation that might be useful to itself and other similar countries. A real life evaluation will be particularly relevant now that new anti-viral drugs, direct-acting antivirals, are being introduced in Egypt.
ANRS 12332 HepNile cohort study will allow "in real life condition" the study of:
- Efficacy (cure rate) and safety of new HCV regimens introduced in Egypt
- Emergence of resistance variants for patients with virological breakthrough
- Factors associated with treatment failure
- Drug-Drug interactions
- Adherence to the treatment regimens
- Conditions
- Chronic Hepatitis C
- Keywords
- Hepatitis C, Genotype 4, DAAs, Real life evaluation
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Safety and tolerance profiles given by the proportion of patients with adverse reactions/events leading to dosage reduction and/or treatment discontinuation.
Measured: End of Treatment Week 12 or Week 24
Adherence to treatment strategy
Adherence given by the proportion of patients who have completed the treatment scheduled (defined by a patient who received 80% of drugs doses for 80% of the expected duration of therapy)
Measured: Post-treatment Week 12 (Week 24 or Week 36)
Resistance-Associated Variants (RAVs)
Assess the occurence of viral resistance patterns in HCV genotype 4 patients
Measured: Post-Treatment Week 12 (Week 24 or Week 36)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start22 Jan 2018
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Institut Pasteur
- Responsible party
- Sponsor
- Investigators
- Yehia Mohamed El Sayed El Shazly, MD, Principal investigator, Ain Shams UniversityArnaud Fontanet, MD, PhD, Principal investigator, Institut Pasteur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03510637
- Sponsor's protocol ID
- ANRS 12332
- Acronym
- HepNile
- Status last verified
- Jul 2019
- First submitted
- 13 Apr 2018
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23286845Doss 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.
PubMed 25937436Obach 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.
PubMed 25581111
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03510637
- Acronym / sponsor ID
- HepNile / ANRS 12332
- Conditions
- Chronic Hepatitis C
- Keywords
- Hepatitis C, Genotype 4, DAAs, Real life evaluation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 7,500 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Institut Pasteur
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 27 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Clinical trials are performed under optimal conditions where patients are highly selected with no co-morbidity, clinical supervision is provided by the best specialists in the field, and strict protocols are used to enhance patients' compliance. Thus, results may not be generalizable to real-world clinical practice.
Observational studies are now gaining attention, showing with previous treatments (combined pegylated interferon and ribavirin) a wide range of results in terms of treatment effectiveness (SVR from 21% to 63% overall), whereas related pivotal clinical trials had estimated SVRs between 54% and 63% overall.
Egypt is the first low/middle-income country where a national treatment program has been established on a large scale, allowing an evaluation that might be useful to itself and other similar countries. A real life evaluation will be particularly relevant now that new anti-viral drugs, direct-acting antivirals, are being introduced in Egypt.
ANRS 12332 HepNile cohort study will allow "in real life condition" the study of:
- Efficacy (cure rate) and safety of new HCV regimens introduced in Egypt
- Emergence of resistance variants for patients with virological breakthrough
- Factors associated with treatment failure
- Drug-Drug interactions
- Adherence to the treatment regimens
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a Chronic Hepatitis C and with prior approval from the Ministry of Health to begin HCV therapy
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sustained Virological Response 12 weeks after the end of treatment (SVR12)
Time frame: Post-treatment Week 12 (Week 24 or Week 36)
Efficacy of treatment given by the proportion of patients with an HCV RNA undetectable 12 weeks after the completion of treatment.
3 secondary outcomes
Proportion of patients with adverse reactions/events leading to dosage reduction and/or treatment discontinuation
Time frame: End of Treatment Week 12 or Week 24
Adherence to treatment strategy
Time frame: Post-treatment Week 12 (Week 24 or Week 36)
Resistance-Associated Variants (RAVs)
Time frame: Post-Treatment Week 12 (Week 24 or Week 36)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Background: PubMed 23286845Esmat 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.
- Background: PubMed 25937436Doss 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.
- Background: PubMed 25581111Obach 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.
- Plan of action for the Prevention , Care \& Treatment of Viral Hepatitis, Egypt, 2014-2018Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yehia Mohamed El Sayed El Shazly, MD principal investigator
Ain Shams University
Arnaud Fontanet, MD, PhD principal investigator
Institut Pasteur
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis C, run by ANRS, Emerging Infectious Diseases at 3 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arnaud Fontanet, MD, PhD (+33 (0) 140613763, arnaud.fontanet@pasteur.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained Virological Response 12 weeks after the end of treatment (SVR12) (time frame: Post-treatment Week 12 (Week 24 or Week 36)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03510637, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2019.