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

NCT01758939 | Unknown DMC

• 2 other identifiers: 2NZEKRI2
• Study Type: observational
• Target: 100,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C, Chronic

Keywords

Peg Interferon,; Ribavirin,; HCV,; Genotype IV.

Outcome Measures

Primary Outcomes (1)

• Assess the response to the Interferon therapy.

  After 72 weeks of the start of therapy of each patient

Secondary Outcomes (1)

• Predictors of response to therapy

  at the end of the study

Study Arms (1)

Hepatitis C virus infected patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

chronic hepatitis C virus , genotype IV, infected Egyptian patients

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

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

Cairo, Cairo Governorate, 002, Egypt

RECRUITING

Related Publications (2)

• 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.

  PMID: 25152984 DERIVED

• 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.

  PMID: 23816271 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gamal Esmat, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

• Abdelrahman Zerki, PHD

  Cairo University

  PRINCIPAL INVESTIGATOR

• Wahid Doss, MD

  Cairo University

  STUDY DIRECTOR

• 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

  STUDY CHAIR

Central Study Contacts

Abdelrahman Zekri, PHD

CONTACT

01007525095; tarneems@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffesor

Study Record Dates

• First Submitted: December 25, 2012
• First Posted: January 1, 2013
• Study Start: January 1, 2011
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2017
• Last Updated: April 17, 2013

Record last verified: 2013-04

Locations

EG (1)