NCT03897608

Brief Summary

To evaluate the effects of DAAs on HRQL in patients with liver cirrhosis secondary to chronic HCV infection

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

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

March 29, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

5 months

First QC Date

March 29, 2019

Last Update Submit

February 9, 2020

Conditions

HCV Related Liver Cirrhosis Direct Acting Antiviral Drugs

Outcome Measures

Primary Outcomes (1)

  • Quality of Life in patients with HCV related liver cirrhosis before and after Direct Acting Antiviral Drugs

    evaluate the effects of DAAs on HRQL in patients with liver cirrhosis secondary to chronic HCV infection

    one year

Interventions

short form 36BEHAVIORAL

The Short Form (SF)-36 Health Survey was used to measure HRQL. The SF-36 generates a profile of HRQL outcomes by measuring health across eight different dimensions: physical functioning, role limitation because of physical health, social functioning, vitality, bodily pain, mental health, role limitation because of emotional problems and general health. Responses to each question within a dimension are combined to generate a score from 0to100; where100 indicates "good health"

Eligibility Criteria

Age11 Months - 12 Months
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Patients with hepatitis C related liver cirrhosis being treatedusing the Egyptian National Guidelines will be enrolled. According to the most updated treatment protocol, patients undergo therapy for a relatively short period (3 to6 months).

You may qualify if:

  • Patients with hepatitis C related liver cirrhosis (diagnosed clinically laboratory and by imaging).
  • Age 18 years or older
  • Eligible for starting DAAs therapy according to Egyptian National Guidelines will be enrolled.
  • Follow up of those patients during and after DAAs therapy (clinically ,laboratory,imaging and with a questionnaire ) to determine HRQL.

You may not qualify if:

  • Any patient with liver cirrhosis secondary to causes other than chronic HCV infection e. g. auto immune liver disease, PBC
  • Coinfection with other viruses as HBV, HIV.
  • Had significant psychiatric illnesses (diagnosed by psychiatrist)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RESIDENT DOCTOR

Study Record Dates

First Submitted

March 29, 2019

First Posted

April 1, 2019

Study Start

February 1, 2020

Primary Completion

July 1, 2020

Study Completion

September 1, 2020

Last Updated

February 11, 2020

Record last verified: 2020-02