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Chronic Hepatitis CeNTCNCT02101177

Evaluation of the National Treatment Program of Hepatitis C in Egypt

An observational study of Chronic Hepatitis C, run by ANRS, Emerging Infectious Diseases at 2 sites in Egypt.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Chronic Hepatitis C
How many people
0 participants
Where
2 sitesEgypt
Study dates
Apr 2014to Dec 2015
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: Patients included in the study will be those with prior approval from the Ministry of Health to begin the bi-therapy and attending two centres of the National Treatment Program.

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Egypt2 sites

  • El Fahera El Fatemia

    Cairo

  • NHTMRI

    Cairo

Other trials in Egypt

About this study

Official title: Evaluation of the National Treatment Program of Hepatitis C in Egypt, Using Data Coming From Two Treatment Centres.

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

Read the detailed description

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).
Keywords
Viral Hepatitis C, Genotype 4, SVR, Egyptian National Program
Medical subject headings
Hepatitis C, Chronic, Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02101177
Study groupRoleWhat they receive
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).
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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Estimate "real life" Sustained Virological Response rate

    Put in place mechanisms to ensure systematic reporting of HCV RNA testing at week 60 in the two project centres to obtain reliable estimates of response rates at this crucial time point.

    Measured: 60 weeks after initiation of treatment

Secondary outcomes (4)

  1. Compare the efficacy of Reiferon®, a biosimilar produced by a local company, Minapharm©, to that of other pegylated interferon of known efficacy (Pegasys®, Pegintron®)

    Response rates at week 12, week 24 and week 60 will be compared across the three treatment regimens available in Egypt. Reiferon's efficacy will be assessed by comparison of:

    • Complete early virological response (cEVR): defined by undetectable HCV RNA at 12 weeks post initiation of dual therapy by PEG IFN + RBV
    • Early virological response (EVR): defined by at least a 2 log-reduction of HCV RNA or undetectable HCV-RNA at 12 weeks of combination therapy.
    • Sustained virological response (SVR): defined by HCV RNA below the detection limit based on quantitative PCR 12 weeks after stopping treatment (week 60)
    • Normalization of ALT: Proportion of patients who have ALT below the upper limit of normal (ULN) during the treatment and 12 weeks after the end of treatment.
    • Adverse events: Evaluation of Incidence of AE and SAE related to dual therapy.

    Measured: 12 weeks, 24 weeks and 60 weeks after initiation of treatment

  2. Understand the determinants of not returning for follow-up among defaulting patients

    Describe the timing of premature termination of treatment, and understand factors associated with it, throughout the 60 weeks of follow-up. Patients compliance in terms of regularity of injections intake will be described

    Measured: 60 weeks after the initiation of dual-therapy

  3. Optimize selection criteria for patients to be enrolled in the National Treatment Program

    Explore various inclusion criteria combining fibrosis stage and serological markers of treatment response to optimize the selection of patients for the National Treatment Program

    Measured: 60 weeks after the initiation of dual therapy

  4. Estimate "real life" Response rate at the end of treatment

    Put in place mechanisms to ensure systematic reporting of HCV RNA testing at week 48 in the two project centres to obtain reliable estimates of response rates at the end of treatment.

    Measured: 48 weeks after initiation of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionJun 2015 (estimated)
  4. Study completionDec 2015 (estimated)

Why it stopped: Study objectives were considered as absolete regarding the arrival of new antiviral drugs in Egypt.

Resources

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
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02101177
Sponsor's protocol ID
ANRS 12291
Acronym
eNTC
Status last verified
Mar 2014
First submitted
26 Mar 2014
Last updated
23 Jul 2014
Results posted
No
Data monitoring committee
No

Publications

  • Breban R, Doss W, Esmat G, Elsayed M, Hellard M, Ayscue P, Albert M, Fontanet A, Mohamed MK. Towards realistic estimates of HCV incidence in Egypt. J Viral Hepat. 2013 Apr;20(4):294-6. doi: 10.1111/j.1365-2893.2012.01650.x. Epub 2012 Sep 13.

    PubMed 23490375

  • Guerra J, Garenne M, Mohamed MK, Fontanet A. HCV burden of infection in Egypt: results from a nationwide survey. J Viral Hepat. 2012 Aug;19(8):560-7. doi: 10.1111/j.1365-2893.2011.01576.x. Epub 2012 Feb 6.

    PubMed 22762140

  • El Makhzangy H, Esmat G, Said M, Elraziky M, Shouman S, Refai R, Rekacewicz C, Gad RR, Vignier N, Abdel-Hamid M, Zalata K, Bedossa P, Pol S, Fontanet A, Mohamed MK. Response to pegylated interferon alfa-2a and ribavirin in chronic hepatitis C genotype 4. J Med Virol. 2009 Sep;81(9):1576-83. doi: 10.1002/jmv.21570.

    PubMed 19626613

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Hepatitis C, run by ANRS, Emerging Infectious Diseases at 2 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 9 inclusion and 17 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: withdrawn, as of the sponsor's last update on 23 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estimate "real life" Sustained Virological Response rate (time frame: 60 weeks after initiation of treatment). 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 NCT02101177, 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 23 Jul 2014.

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