NCT03591783

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

July 19, 2018

Status Verified

July 1, 2018

Enrollment Period

1.3 years

First QC Date

July 9, 2018

Last Update Submit

July 9, 2018

Conditions

Hepatitis c

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

study group

All patients will be subjected to: Baseline investigations, end of treatment investigations and 3 months after treatment investigations.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 9, 2018

First Posted

July 19, 2018

Study Start

August 1, 2018

Primary Completion

November 1, 2019

Study Completion

December 1, 2019

Last Updated

July 19, 2018

Record last verified: 2018-07