Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Cairo University
Sponsor:
Information provided by (Responsible Party):
Zekri AR, Cairo University
ClinicalTrials.gov Identifier:
NCT01758939
First received: December 25, 2012
Last updated: April 15, 2013
Last verified: April 2013
  Purpose

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.


Condition
Hepatitis C, Chronic

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Target Follow-Up Duration: 18 Months
Official Title: Phase 4 Predictors of Response to Combined Pegylated Interferon and Ribavirin in Chronic Hepatitis C Genotype IV Infected Egyptian Patients

Resource links provided by NLM:


Further study details as provided by Cairo University:

Primary Outcome Measures:
  • Assess the response to the Interferon therapy. [ Time Frame: After 72 weeks of the start of therapy of each patient ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Predictors of response to therapy [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 100000
Study Start Date: January 2011
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hepatitis C virus infected patients

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

chronic hepatitis C virus , genotype IV, infected Egyptian patients

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01758939

Contacts
Contact: Abdelrahman Zekri, PHD 01007525095 ext 00202 tarneems@yahoo.com

Locations
Egypt
Viral Hepatitis Treatment Units affiliated to National Committee for Control of Viral Hepatitis Recruiting
Cairo, Egypt, 002
Contact: Abdelrahman Zekri, PHD    01001413521 ext 002    ncizekri@yahoo.com   
Principal Investigator: Maissa El Raziky, MD         
Sponsors and Collaborators
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
  More Information

No publications provided by Cairo University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Zekri AR, Proffesor, Cairo University
ClinicalTrials.gov Identifier: NCT01758939     History of Changes
Other Study ID Numbers: 2, NZEKRI2
Study First Received: December 25, 2012
Last Updated: April 15, 2013
Health Authority: Egypt: Ministry of Health and Population

Keywords provided by Cairo University:
Peg Interferon,
Ribavirin,
HCV,
Genotype IV.

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferons
Ribavirin
Anti-Infective Agents
Antimetabolites
Antineoplastic Agents
Antiviral Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014