Clinical trial NCT01758939: Predictors of Response to Combined Pegylated Interferon and Ribavirin in Chronic Hepatitis C Infected Egyptian Patients
Official title: Phase 4 Predictors of Response to Combined Pegylated Interferon and Ribavirin in Chronic Hepatitis C Genotype IV Infected Egyptian Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C, Chronic
Keywords: Peg Interferon,
Ribavirin,
HCV,
Genotype IV.
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2013-01-01
Enrollment: 100000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: chronic hepatitis C virus , genotype IV, infected Egyptian patients

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.

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

Primary outcomes:
measure: Assess the response to the Interferon therapy.
timeFrame: After 72 weeks of the start of therapy of each patient
Secondary outcomes:
measure: Predictors of response to therapy
timeFrame: at the end of the study
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Viral Hepatitis Treatment Units affiliated to National Committee for Control of Viral Hepatitis
Study officials:
affiliation: Cairo University
name: Gamal Esmat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Abdelrahman Zerki, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Wahid Doss, MD
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Maissa El Raziky, MD
role: STUDY_CHAIR
affiliation: Cairo University
name: Gamal Sheha, MD
role: STUDY_CHAIR
affiliation: Cairo University
name: Tarneem Darwish, MSc.
role: STUDY_CHAIR
affiliation: Cairo University
name: samy zaki, MD
role: STUDY_CHAIR
affiliation: Cairo Universty
name: Magdi El-Serafy, MD
role: STUDY_CHAIR
affiliation: Cairo University
name: Fathalla Sedky, MD
role: STUDY_CHAIR
affiliation: Cairo University
name: Ahmed M Nasr, MD
role: STUDY_CHAIR
affiliation: Cairo University
name: Mostafa Gabr, MD
role: STUDY_CHAIR
affiliation: Cairo University
name: Ali kassem, MD
role: STUDY_CHAIR
affiliation: Cairo University
name: Ibrahim Metawea, MD
role: STUDY_CHAIR
affiliation: Cairo University
name: Noaman Al-Garem, MD
role: STUDY_CHAIR
affiliation: Cairo University
name: Hassan Hamdy, MD
role: STUDY_CHAIR
affiliation: Cairo University
name: Tawheed Mwafy, MD
role: STUDY_CHAIR
affiliation: Cairo University
name: Khalil A Khalil, MD
role: STUDY_CHAIR
affiliation: Cairo University
name: Magdy Atta, MD
role: STUDY_CHAIR
affiliation: Cairo University
name: Osama E Salem, MD
role: STUDY_CHAIR
affiliation: Cairo University
name: Mohamed A Afify, MD
role: STUDY_CHAIR
affiliation: Cairo University
name: Mohamed S Al-Shazly, MD
role: STUDY_CHAIR
affiliation: Cairo University
name: Hamdy Mahfouz, MD
role: STUDY_CHAIR
affiliation: Cairo University
name: Mustafa Gabr, MD
role: STUDY_CHAIR
affiliation: Cairo University
name: Monquez Motaea, MD
role: STUDY_CHAIR
affiliation: Cairo University
name: Hossam Abdel-Latif, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.