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

April 15, 2013 updated by: Zekri AR, Cairo University

Phase 4 Predictors of Response to Combined Pegylated Interferon and Ribavirin in Chronic Hepatitis C Genotype IV Infected Egyptian Patients

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

100000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt, 002
        • Recruiting
        • Viral Hepatitis Treatment Units affiliated to National Committee for Control of Viral Hepatitis
        • Contact:
        • Principal Investigator:
          • Maissa El Raziky, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

chronic hepatitis C virus , genotype IV, infected Egyptian patients

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort

Cohorts and Interventions

Group / Cohort
Hepatitis C virus infected patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess the response to the Interferon therapy.
Time Frame: After 72 weeks of the start of therapy of each patient
After 72 weeks of the start of therapy of each patient

Secondary Outcome Measures

Outcome Measure
Time Frame
Predictors of response to therapy
Time Frame: at the end of the study
at the end of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Gamal Esmat, MD, Cairo University
  • Principal Investigator: Abdelrahman Zerki, PHD, Cairo University
  • Study Director: Wahid Doss, MD, Cairo University
  • Study Chair: Maissa El Raziky, MD, Cairo University
  • Study Chair: Gamal Sheha, MD, Cairo University
  • Study Chair: Tarneem Darwish, MSc., Cairo University
  • Study Chair: samy zaki, MD, Cairo University
  • Study Chair: Magdi El-Serafy, MD, Cairo Universty
  • Study Chair: Fathalla Sedky, MD, Cairo University
  • Study Chair: Ahmed M Nasr, MD, Cairo University
  • Study Chair: Mostafa Gabr, MD, Cairo University
  • Study Chair: Ali kassem, MD, Cairo University
  • Study Chair: Ibrahim Metawea, MD, Cairo University
  • Study Chair: Noaman Al-Garem, MD, Cairo University
  • Study Chair: Hassan Hamdy, MD, Cairo University
  • Study Chair: Tawheed Mwafy, MD, Cairo University
  • Study Chair: Khalil A Khalil, MD, Cairo University
  • Study Chair: Magdy Atta, MD, Cairo University
  • Study Chair: Osama E Salem, MD, Cairo University
  • Study Chair: Mohamed A Afify, MD, Cairo University
  • Study Chair: Mohamed S Al-Shazly, MD, Cairo University
  • Study Chair: Hamdy Mahfouz, MD, Cairo University
  • Study Chair: Mustafa Gabr, MD, Cairo University
  • Study Chair: Monquez Motaea, MD, Cairo University
  • Study Chair: Hossam Abdel-Latif, MD, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

December 25, 2012

First Submitted That Met QC Criteria

December 25, 2012

First Posted (Estimate)

January 1, 2013

Study Record Updates

Last Update Posted (Estimate)

April 17, 2013

Last Update Submitted That Met QC Criteria

April 15, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2
  • NZEKRI2 (Registry Identifier: NZEKRI)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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