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"Real Life" Evaluation of Efficacy and Safety of Direct Antiviral Agents (DAAs) for the Treatment of Hepatitis C Virus in Egypt (HepNile)

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ClinicalTrials.gov Identifier: NCT03510637
Recruitment Status : Recruiting
First Posted : April 27, 2018
Last Update Posted : April 27, 2018
Sponsor:
Collaborator:
Institut Pasteur
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

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).

Condition or disease
Chronic Hepatitis C

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

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Study Type : Observational
Estimated Enrollment : 7500 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : January 22, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    Safety and tolerance profiles given by the proportion of patients with adverse reactions/events leading to dosage reduction and/or treatment discontinuation.

  2. Adherence to treatment strategy [ Time Frame: Post-treatment Week 12 (Week 24 or Week 36) ]
    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)

  3. Resistance-Associated Variants (RAVs) [ Time Frame: Post-Treatment Week 12 (Week 24 or Week 36) ]
    Assess the occurence of viral resistance patterns in HCV genotype 4 patients


Biospecimen Retention:   Samples With DNA

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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a Chronic Hepatitis C and with prior approval from the Ministry of Health to begin HCV therapy
Criteria

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%)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03510637


Contacts
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Contact: Arnaud Fontanet, MD, PhD +33 (0) 140613763 arnaud.fontanet@pasteur.fr
Contact: Amélie Dublineau, PhD +33(0)140613887 amelie.dublineau@pasteur.fr

Locations
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Egypt
El Fatemia El Kahera Centre Recruiting
Cairo, Egypt
National Hepatology and Tropical Medicine Institute Recruiting
Cairo, Egypt
New Cairo Hospital Recruiting
Cairo, Egypt
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Institut Pasteur
Investigators
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Principal Investigator: Yehia Mohamed El Sayed El Shazly, MD Ain Shams University
Principal Investigator: Arnaud Fontanet, MD, PhD Institut Pasteur

Additional Information:
Publications:
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Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT03510637     History of Changes
Other Study ID Numbers: ANRS 12332
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
Hepatitis C, Genotype 4, DAAs, Real life evaluation

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Anti-Infective Agents