Predictors of Response to Combined Pegylated Interferon a... | NCT01758939

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

NCT01758939

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Apr 17, 2013Estimated

Enrollment

100,000Estimated

Phase

Not provided

Conditions

Hepatitis C, Chronic

Interventions

Not provided

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NZEKRI2	Registry Identifier	NZEKRI

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Jan 2016Estimated

Completion Date

Jan 2017Estimated

First Submitted Date

Dec 25, 2012

First Submission Date that Met QC Criteria

Dec 25, 2012

First Posted Date

Jan 1, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2013

Last Update Posted Date

Apr 17, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

18 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100,000Estimated

Label	Type	Description	Intervention Names
Hepatitis C virus infected patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assess the response to the Interferon therapy.		After 72 weeks of the start of therapy of each patient

Secondary Outcomes

Measure	Description	Time Frame
Predictors of response to therapy		at the end of the study

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

chronic hepatitis C virus , genotype IV, infected Egyptian patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Abdelrahman Zekri, PHD	Contact	01007525095	00202	tarneems@yahoo.com

Overall Officials

Name	Affiliation	Role
Gamal Esmat, MD	Cairo University	Principal Investigator
Abdelrahman Zerki, PHD	Cairo University	Principal Investigator
Wahid Doss, MD

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Viral Hepatitis Treatment Units affiliated to National Committee for Control of Viral Hepatitis	Recruiting	Cairo	Cairo Governorate	002	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25152984	Derived	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.
23816271	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.

ID	Term
D006526	Hepatitis C
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections