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

NCT ID: NCT01758939

Last Updated: 2013-04-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2017-01-31

Brief 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.

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.

Conditions

Hepatitis C, Chronic

Study Design

• Observational Model Type: COHORT

Study Groups

Hepatitis C virus infected patients

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Zekri AR

Proffesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gamal Esmat, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Abdelrahman Zerki, PHD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Wahid Doss, MD

Role: STUDY_DIRECTOR

Cairo University

Maissa El Raziky, MD

Role: STUDY_CHAIR

Cairo University

Gamal Sheha, MD

Role: STUDY_CHAIR

Cairo University

Tarneem Darwish, MSc.

Role: STUDY_CHAIR

Cairo University

samy zaki, MD

Role: STUDY_CHAIR

Cairo University

Magdi El-Serafy, MD

Role: STUDY_CHAIR

Cairo Universty

Fathalla Sedky, MD

Role: STUDY_CHAIR

Cairo University

Ahmed M Nasr, MD

Role: STUDY_CHAIR

Cairo University

Mostafa Gabr, MD

Role: STUDY_CHAIR

Cairo University

Ali kassem, MD

Role: STUDY_CHAIR

Cairo University

Ibrahim Metawea, MD

Role: STUDY_CHAIR

Cairo University

Noaman Al-Garem, MD

Role: STUDY_CHAIR

Cairo University

Hassan Hamdy, MD

Role: STUDY_CHAIR

Cairo University

Tawheed Mwafy, MD

Role: STUDY_CHAIR

Cairo University

Khalil A Khalil, MD

Role: STUDY_CHAIR

Cairo University

Magdy Atta, MD

Role: STUDY_CHAIR

Cairo University

Osama E Salem, MD

Role: STUDY_CHAIR

Cairo University

Mohamed A Afify, MD

Role: STUDY_CHAIR

Cairo University

Mohamed S Al-Shazly, MD

Role: STUDY_CHAIR

Cairo University

Hamdy Mahfouz, MD

Role: STUDY_CHAIR

Cairo University

Mustafa Gabr, MD

Role: STUDY_CHAIR

Cairo University

Monquez Motaea, MD

Role: STUDY_CHAIR

Cairo University

Hossam Abdel-Latif, MD

Role: STUDY_CHAIR

Cairo University

Locations

Viral Hepatitis Treatment Units affiliated to National Committee for Control of Viral Hepatitis

Cairo, Cairo Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Abdelrahman Zekri, PHD

Role: CONTACT

tarneems@yahoo.com

01007525095 ext. 00202

Facility Contacts

Abdelrahman Zekri, PHD

Role: primary

ncizekri@yahoo.com

01001413521 ext. 002

References

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.

Reference Type: DERIVED

PMID: 25152984 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23816271 (View on PubMed)

Other Identifiers

NZEKRI2

Identifier Type: REGISTRY

Identifier Source: secondary_id

2

Identifier Type: -

Identifier Source: org_study_id