Impact of Sustained Virologic Response on Glycemic Contro... | NCT03591783

Studies
Impact of Sustained Virologic Response on Glycemic Control Among Diabetic Patients With Hepatitis C Virus Related Liver Disease

NCT03591783

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Jul 19, 2018Actual

Enrollment

140Estimated

Phase

Not provided

Conditions

Hepatitis c

Interventions

Not provided

Countries

Not provided

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

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2018Estimated

Primary Completion Date

Nov 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Jul 9, 2018

First Submission Date that Met QC Criteria

Jul 9, 2018

First Posted Date

Jul 19, 2018Actual

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

Jul 9, 2018

Last Update Posted Date

Jul 19, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Hepatitis C virus (HCV) is a major cause of chronic liver disease. The World Health Organization has reported that 170 million people are chronically infected with HCV globally. The highest prevalence of HCV infection worldwide exists in Egypt (15%); 90% of infection among Egyptian patients is due to genotype 4

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

140Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
study group		All patients will be subjected to: Baseline investigations, end of treatment investigations and 3 months after treatment investigations.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the percentage of patients with glycemic control	Exploring the impact of achieving SVR by directly acting antiviral drugs on glycemic control among diabetic patients with HCV infection.	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Chronic HCV infection will be diagnosed based on positive testing for serum HCV RNA and anti-HCV Ab.
Diagnosis of type 2 DM will depend on fasting level of serum glucose more than 126 mg/dl and/or serum level of HbA1c more than 6.5 % on oral hypoglycemic therapy.

Exclusion Criteria:

Chronic hepatitis due to causes other than HCV infection
Coinfection with HBV infection
Hepatocellular carcinoma
Child C stage of liver cirrhosis.
Patients with type I diabetes mellitus.
Cardiopulmonary diseases.
Major illness.
Patient receiving corticosteroids.
Patient refused consent.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients with chronic HCV infection with type 2 DM, who are eligible for antiviral therapy.

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D006526	Hepatitis C

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human

Browse Leaves

Not provided

Browse Branches

Not provided