CClinicalTrials.gg
Status unknownNCT01758939Updated Apr 17, 2013

Predictors of Response to Combined Pegylated Interferon and Ribavirin in Chronic Hepatitis C Infected Egyptian Patients

An observational study in Hepatitis C, Chronic, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2013-04-17.

Sponsored by Cairo University · Observational

The sponsor has not verified this record recently (last verified Apr 2013), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Enrollment
100,000
Ages
18 Years to 60 Years
Sex
All
01

Study summary

Retrospective prospective cohort study aimed at Assessing the predictors to the response to the antiviral combined therapy with pegylated Interferon (Both types: Alfa 2 A and Alfa 2 B) in hepatitis C virus infected Egyptian patients.

Read the detailed description

Retrospective prospective cohort study conducted on HCV infected patients treated with Interferon alpha therapy, the retrospective part of the study includes the data of the patients retrieved from medical records from the period from September 2006 till January 2011. Then from January 2011 the study became prospective national study. Responders to therapy were defined by normalization of serum alanine aminotransferase (ALT) and absence of detectable serum HCV RNA at the end of treatment (48 weeks). Relapsed responders to therapy were defined by normalization of serum ALT and absence of detectable serum HCV RNA at the end of treatment but with an increase of the serum ALT and the presence of HCV RNA at follow-up 72 weeks). Non-responders were defined by elevated serum ALT and the presence of HCV RNA at the end of treatment. All patients will sign a written informed consent to share in this clinical registry by their data and biological samples. Sub-studies will be conducted on subgroups of patients sharing in this main study after signing a written informed consent.

02

Conditions studied

  • Hepatitis C, Chronic

Keywords

  • Peg Interferon,
  • Ribavirin,
  • HCV,
  • Genotype IV.
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's planned enrollment of 100,000 is above the median of 250 across 687 observational studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

chronic hepatitis C virus , genotype IV, infected Egyptian patients

Inclusion criteria

  • Age: above eighteen years and below 60

    • Detectable HCV RNA in serum by PCR
    • ALT level ranged from normal to three fold elevation.
    • Minimum hematological values of hemoglobin of 10.5 g/dl for females, 12g/dl for males; white blood count 3×109/L; platelet counts not less than 100,000/mm3.
    • Bilirubin, albumin, prothrombin time and creatinine within normal limits.
    • A suitable method for assessment of fibrosis lik liver biopsy or fibroscan will be done before the start of treatment to assess the degree of necroinflammatory response to HCV, which was further subgrouped by HAI scoring system into mild, moderate \& severe.

Exclusion criteria

Exclusion Criteria:

  • Decompensated cirrhosis
  • Other causes of liver diseases
  • Autoimmune disorders
  • Uncontrolled diabetes
  • Thyroid dysfunction
  • Neurological or cardiovascular disease
  • Malignancy
05

Study design

Observational model
Cohort
Enrollment
100,000 participants (estimated)
Target follow-up
18 Months
Patient registry
Yes

Groups and cohorts

  • Hepatitis C virus infected patients
06

What researchers measure

Primary outcomes

  1. Assess the response to the Interferon therapy.

    Time frame: After 72 weeks of the start of therapy of each patient

Secondary outcomes

  1. Predictors of response to therapy

    Time frame: at the end of the study

07

Study locations

1 of 1 sites recruiting
  • Viral Hepatitis Treatment Units affiliated to National Committee for Control of Viral Hepatitis
    Cairo, 002, Egypt
    • Abdelrahman Zekri, PHD · Contact · ncizekri@yahoo.com · 01001413521
    • Maissa El Raziky, MD · Principal investigator
    Recruiting
08

References and documents

Publications

  • N Zekri AR, Raafat AM, Elmasry S, Bahnassy AA, Saad Y, Dabaon HA, El-Kassas M, Shousha HI, Nassar AA, El-Dosouky MA, Hussein N. Promotor methylation: does it affect response to therapy in chronic hepatitis C (G4) or fibrosis? Ann Hepatol. 2014 Sep-Oct;13(5):518-24. PubMed 25152984 ↗
  • Zekri AR, Bahnassy AA, Mohamed WS, Alam El-Din HM, Shousha HI, Zayed N, Eldahshan DH, Abdel-Aziz AO. Dynamic interplay between CXCL levels in chronic hepatitis C patients treated by interferon. Virol J. 2013 Jul 1;10:218. doi: 10.1186/1743-422X-10-218. PubMed 23816271 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01758939
Lead sponsor
Cairo University
Responsible party
Zekri AR (Proffesor, Cairo University) — Principal investigator
First posted
Jan 1, 2013
Start date
Jan 2011
Primary completion
Jan 2016 (estimated)
Completion
Jan 2017 (estimated)
Last update
Apr 17, 2013

Study contacts

Abdelrahman Zekri, PHD
Contact
tarneems@yahoo.com
01007525095 ext. 00202
Gamal Esmat, MD
principal investigator · Cairo University
Abdelrahman Zerki, PHD
principal investigator · Cairo University
Wahid Doss, MD
study director · Cairo University
Maissa El Raziky, MD
study chair · Cairo University
Gamal Sheha, MD
study chair · Cairo University
Tarneem Darwish, MSc.
study chair · Cairo University
samy zaki, MD
study chair · Cairo University
Magdi El-Serafy, MD
study chair · Cairo Universty
Fathalla Sedky, MD
study chair · Cairo University
Ahmed M Nasr, MD
study chair · Cairo University
Mostafa Gabr, MD
study chair · Cairo University
Ali kassem, MD
study chair · Cairo University
Ibrahim Metawea, MD
study chair · Cairo University
Noaman Al-Garem, MD
study chair · Cairo University
Hassan Hamdy, MD
study chair · Cairo University
Tawheed Mwafy, MD
study chair · Cairo University
Khalil A Khalil, MD
study chair · Cairo University
Magdy Atta, MD
study chair · Cairo University
Osama E Salem, MD
study chair · Cairo University
Mohamed A Afify, MD
study chair · Cairo University
Mohamed S Al-Shazly, MD
study chair · Cairo University
Hamdy Mahfouz, MD
study chair · Cairo University
Mustafa Gabr, MD
study chair · Cairo University
Monquez Motaea, MD
study chair · Cairo University
Hossam Abdel-Latif, MD
study chair · Cairo University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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