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

Hepatitis C, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01758939
• Other study ID #: 2
• Secondary ID: NZEKRI2
• Status: Recruiting
• Phase: N/A
• First received: December 25, 2012
• Last updated: April 15, 2013
• Start date: January 2011
• Est. completion date: January 2017

Study information

• Verified date: April 2013
• Source: Cairo University
• Contact: Abdelrahman Zekri, PHD
• Phone: 01007525095
• Email: tarneems[@]yahoo.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100000
• Est. completion date: January 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
Egypt	Viral Hepatitis Treatment Units affiliated to National Committee for Control of Viral Hepatitis	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the response to the Interferon therapy.		After 72 weeks of the start of therapy of each patient	No
Secondary	Predictors of response to therapy		at the end of the study	No