HCV Related Liver Cirrhosis Direct Acting Antiviral DrugsNCT03897608
Quality of Life in Patients With HCV Related Liver Cirrhosis Before and After Direct Acting Antiviral Drugs
An observational study of HCV Related Liver Cirrhosis Direct Acting Antiviral Drugs, run by Assiut University.
Trial summary
To evaluate the effects of DAAs on HRQL in patients with liver cirrhosis secondary to chronic HCV infection Read more about this study
- Who is it for?
- Ages 11 to 12 months
- Conditions the study is for
- HCV Related Liver Cirrhosis Direct Acting Antiviral Drugs
- What is being tested?
- short form 36
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2020to 1 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 12 months
- All sexes
- Child
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).
Who may be able to join
- 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.
Who cannot join
- 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)
About this study
To evaluate the effects of DAAs on HRQL in patients with liver cirrhosis secondary to chronic HCV infection
Read the detailed description
Hepatitis C has been associated with substantial resource utilization as a result of its effect on the liver as well as other organ systems (the extrahepatic manifestations of HCV). It has been widely reported to have a profound negative impact on patient's health-related quality of life (HRQL).
The reduction of HRQL is probably also due to physical and psychiatric symptoms as a direct consequence of this chronic infection and its sequelae (such as cirrhosis). The chronic inflammation is believed to signal the brain and to give rise to neurovegetative symptoms (e.g. malaise and fatigue) and to amongst others depression and concentration difficulties. Possibly, also the brain itself is infected by HCV . The Egyptian government introduced Sofosbuvir as the first DAAs into Egypt through the government funded National Treatment Program. These agents are highly efficacious with significantly fewer side effects .
To date, there is only one study reported about how Egyptian HCV patients receiving the new DAAs perceive their HRQL. This study is first one to be done in Upper Egypt to assess health-related quality of life of HCV patients receiving direct acting antivirals (DAAs) therapy prior and at the end of therapy
- Being tested
- short form 36
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
short form 36Behavioural
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"
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start1 Feb 2020 (estimated)
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCV Related Liver Cirrhosis Direct Acting Antiviral DrugsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam eldeen Esmael Zayan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03897608
- Sponsor's protocol ID
- life quality with DAAD
- Status last verified
- Feb 2020
- First submitted
- 29 Mar 2019
- Last updated
- 11 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life in Patients With HCV Related Liver Cirrhosis Before and After Direct Acting Antiviral Drugs
- ClinicalTrials.gov ID
- NCT03897608
- Acronym / sponsor ID
- life quality with DAAD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 1 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effects of DAAs on HRQL in patients with liver cirrhosis secondary to chronic HCV infection
Detailed description
Hepatitis C has been associated with substantial resource utilization as a result of its effect on the liver as well as other organ systems (the extrahepatic manifestations of HCV). It has been widely reported to have a profound negative impact on patient's health-related quality of life (HRQL).
The reduction of HRQL is probably also due to physical and psychiatric symptoms as a direct consequence of this chronic infection and its sequelae (such as cirrhosis). The chronic inflammation is believed to signal the brain and to give rise to neurovegetative symptoms (e.g. malaise and fatigue) and to amongst others depression and concentration difficulties. Possibly, also the brain itself is infected by HCV . The Egyptian government introduced Sofosbuvir as the first DAAs into Egypt through the government funded National Treatment Program. These agents are highly efficacious with significantly fewer side effects .
To date, there is only one study reported about how Egyptian HCV patients receiving the new DAAs perceive their HRQL. This study is first one to be done in Upper Egypt to assess health-related quality of life of HCV patients receiving direct acting antivirals (DAAs) therapy prior and at the end of therapy
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 11 to 12 months
- Sex
- All
- Age groups
- Child
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| short form 36The 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" | Behavioural | – |
Primary outcome
Quality of Life in patients with HCV related liver cirrhosis before and after Direct Acting Antiviral Drugs
Time frame: one year
evaluate the effects of DAAs on HRQL in patients with liver cirrhosis secondary to chronic HCV infection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of HCV Related Liver Cirrhosis Direct Acting Antiviral Drugs, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life in patients with HCV related liver cirrhosis before and after Direct Acting Antiviral Drugs (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.