Predictors of Response to HCV TretmentNCT03480269
Very Rapid and Rapid Virological Response as Predictors of Response of HCV Tretment
An observational study of Predictors of Response to HCV Tretment, run by Assiut University.
Trial summary
assessment of very rapid virological response and rapid virological response as predictors of response to sofosbuvir and daclatasvir in treatment of cirrhotic and non-cirrhotic patients with HCV, eligible to treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Predictors of Response to HCV Tretment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2018to 30 Apr 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with HCV related liver disease ( either cirrhotic or non cirrhotic) eligible to tretment
Who may be able to join
- Anti HCV positive patients either chronic HCV or liver cirrhosis.
- Detectable HCV RNA by quantitative PCR prior to treatment.
- Naïve patients (not received any HCV treatment regimen before)
Who cannot join
- Patients with hepatocellular carcinoma( HCC)
- Patients with combined HBV and HCV
About this study
Official title: Very Rapid and Rapid Virological Response as Predictors of Response to Sofosbuvir / Daclatasvir Treatment of HCV Related Liver Disease
assessment of very rapid virological response and rapid virological response as predictors of response to sofosbuvir and daclatasvir in treatment of cirrhotic and non-cirrhotic patients with HCV, eligible to treatment.
Read the detailed description
Chronic hepatitis C infection (CHC) is a global health problem, with an estimated 120 to 130 million chronic hepatitis C virus (HCV) carriers worldwide Therefore, early recognition and effective management of the disease can modify its natural history
. There is a growing body of evidence that suggests that treatment will help reduce liver inflammation, may reverse liver damage (scarring),slow down disease progression and improve symptoms and quality of life. All of these factors are important reasons to seek HCV medical treatment Identifying host-viral factors that predict the likelihood of SVR prior to initiating therapy would be a very useful clinical tool that could help reduce costs and avoid unnecessary exposure to therapy with significant side effects Little is known about predictors of failure to achieve SVR with DAAs. Although numerous clinical parameters predicted poor response to pegylated IFN treatment , none of them have been shown to be associated with virological relapse after DAA based therapy
Treatment response terms:
The ultra rapid virological response (uRVR) is a new endpoint that we defined as an undetectable serum HCV RNA at the end of 1st week of therapy.
The very rapid virologic response( vRVR )defined as undetectable serum HCV RNA level at week 2.
The rapid virological response (RVR) defined as undetectable serum HCV RNA after 4 weeks of treatment sustained virological response (SVR), which is defined by the undetectable serum HCV RNA 12-24 weeks after the end of treatment Relapser was defined as undetectable viral load at the end of DAA treatment but subsequent detectable viral load at 12 weeks after treatment end.
- Conditions
- Predictors of Response to HCV Tretment
What is being measured
The primary outcome is the main question the study is designed to answer.
Rapid virological response (undetected HCV RNA after 4 weeks from the begin of antiviral treatment)
To assess rapid virological response as a predictor of response to sofosbuvir and daclatasvir in treatment of cirrhotic and non-cirrhotic patients with HCV. It measure the relation between rapid virological response and achievment of sustained virological response (Undetected HCV RNA 12-24 weeks after the end of treatment )
Measured: April 2018 to April 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start1 Aug 2018 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Predictors of Response to HCV TretmentStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Mohammed Mahrous Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480269
- Sponsor's protocol ID
- HCV tretment
- Status last verified
- Mar 2018
- First submitted
- 2 Mar 2018
- Last updated
- 6 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Patel K, Lucas JE, Thompson JW, Dubois LG, Tillmann HL, Thompson AJ, Uzarski D, Califf RM, Moseley MA, Ginsburg GS, McHutchison JG, McCarthy JJ; MURDOCK Horizon 1 Study Team. High predictive accuracy of an unbiased proteomic profile for sustained virologic response in chronic hepatitis C patients. Hepatology. 2011 Jun;53(6):1809-18. doi: 10.1002/hep.24284. Epub 2011 May 14.
PubMed 21381069Cavalcante LN, Lyra AC. Predictive factors associated with hepatitis C antiviral therapy response. World J Hepatol. 2015 Jun 28;7(12):1617-31. doi: 10.4254/wjh.v7.i12.1617.
PubMed 26140082Childs K, Merritt E, Considine A, Sanchez-Fueyo A, Agarwal K, Martinez-Llordella M, Carey I. Immunological Predictors of Nonresponse to Directly Acting Antiviral Therapy in Patients With Chronic Hepatitis C and Decompensated Cirrhosis. Open Forum Infect Dis. 2017 Apr 3;4(2):ofx067. doi: 10.1093/ofid/ofx067. eCollection 2017 Spring.
PubMed 28584852Yakoot M, Abdo AM, Yousry A, Helmy S. Very rapid virologic response and early HCV response kinetics, as quick measures to compare efficacy and guide a personalized response-guided therapy. Drug Des Devel Ther. 2016 Aug 25;10:2659-67. doi: 10.2147/DDDT.S111496. eCollection 2016.
PubMed 27601883Yek C, de la Flor C, Marshall J, Zoellner C, Thompson G, Quirk L, Mayorga C, Turner BJ, Singal AG, Jain MK. Effectiveness of direct-acting antiviral therapy for hepatitis C in difficult-to-treat patients in a safety-net health system: a retrospective cohort study. BMC Med. 2017 Nov 20;15(1):204. doi: 10.1186/s12916-017-0969-3.
PubMed 29151365
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Very Rapid and Rapid Virological Response as Predictors of Response to Sofosbuvir / Daclatasvir Treatment of HCV Related Liver Disease
- ClinicalTrials.gov ID
- NCT03480269
- Acronym / sponsor ID
- HCV tretment
- Conditions
- Predictors of Response to HCV Tretment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 29 Mar 2018 (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.
assessment of very rapid virological response and rapid virological response as predictors of response to sofosbuvir and daclatasvir in treatment of cirrhotic and non-cirrhotic patients with HCV, eligible to treatment.
Detailed description
Chronic hepatitis C infection (CHC) is a global health problem, with an estimated 120 to 130 million chronic hepatitis C virus (HCV) carriers worldwide Therefore, early recognition and effective management of the disease can modify its natural history
. There is a growing body of evidence that suggests that treatment will help reduce liver inflammation, may reverse liver damage (scarring),slow down disease progression and improve symptoms and quality of life. All of these factors are important reasons to seek HCV medical treatment Identifying host-viral factors that predict the likelihood of SVR prior to initiating therapy would be a very useful clinical tool that could help reduce costs and avoid unnecessary exposure to therapy with significant side effects Little is known about predictors of failure to achieve SVR with DAAs. Although numerous clinical parameters predicted poor response to pegylated IFN treatment , none of them have been shown to be associated with virological relapse after DAA based therapy
Treatment response terms:
The ultra rapid virological response (uRVR) is a new endpoint that we defined as an undetectable serum HCV RNA at the end of 1st week of therapy.
The very rapid virologic response( vRVR )defined as undetectable serum HCV RNA level at week 2.
The rapid virological response (RVR) defined as undetectable serum HCV RNA after 4 weeks of treatment sustained virological response (SVR), which is defined by the undetectable serum HCV RNA 12-24 weeks after the end of treatment Relapser was defined as undetectable viral load at the end of DAA treatment but subsequent detectable viral load at 12 weeks after treatment end.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with HCV related liver disease ( either cirrhotic or non cirrhotic) eligible to tretment
Key inclusion criteria (3 listed)
- Anti HCV positive patients either chronic HCV or liver cirrhosis.
- Detectable HCV RNA by quantitative PCR prior to treatment.
- Naïve patients (not received any HCV treatment regimen before)
Key exclusion criteria (2 listed)
- Patients with hepatocellular carcinoma( HCC)
- Patients with combined HBV and HCV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rapid virological response (undetected HCV RNA after 4 weeks from the begin of antiviral treatment)
Time frame: April 2018 to April 2019
To assess rapid virological response as a predictor of response to sofosbuvir and daclatasvir in treatment of cirrhotic and non-cirrhotic patients with HCV. It measure the relation between rapid virological response and achievment of sustained virological response (Undetected HCV RNA 12-24 weeks after the end of treatment )
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Background: PubMed 21381069Patel K, Lucas JE, Thompson JW, Dubois LG, Tillmann HL, Thompson AJ, Uzarski D, Califf RM, Moseley MA, Ginsburg GS, McHutchison JG, McCarthy JJ; MURDOCK Horizon 1 Study Team. High predictive accuracy of an unbiased proteomic profile for sustained virologic response in chronic hepatitis C patients. Hepatology. 2011 Jun;53(6):1809-18. doi: 10.1002/hep.24284. Epub 2011 May 14.
- Background: PubMed 26140082Cavalcante LN, Lyra AC. Predictive factors associated with hepatitis C antiviral therapy response. World J Hepatol. 2015 Jun 28;7(12):1617-31. doi: 10.4254/wjh.v7.i12.1617.
- Background: PubMed 28584852Childs K, Merritt E, Considine A, Sanchez-Fueyo A, Agarwal K, Martinez-Llordella M, Carey I. Immunological Predictors of Nonresponse to Directly Acting Antiviral Therapy in Patients With Chronic Hepatitis C and Decompensated Cirrhosis. Open Forum Infect Dis. 2017 Apr 3;4(2):ofx067. doi: 10.1093/ofid/ofx067. eCollection 2017 Spring.
- Background: PubMed 27601883Yakoot M, Abdo AM, Yousry A, Helmy S. Very rapid virologic response and early HCV response kinetics, as quick measures to compare efficacy and guide a personalized response-guided therapy. Drug Des Devel Ther. 2016 Aug 25;10:2659-67. doi: 10.2147/DDDT.S111496. eCollection 2016.
- Background: PubMed 29151365Yek C, de la Flor C, Marshall J, Zoellner C, Thompson G, Quirk L, Mayorga C, Turner BJ, Singal AG, Jain MK. Effectiveness of direct-acting antiviral therapy for hepatitis C in difficult-to-treat patients in a safety-net health system: a retrospective cohort study. BMC Med. 2017 Nov 20;15(1):204. doi: 10.1186/s12916-017-0969-3.
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 Predictors of Response to HCV Tretment, 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 3 inclusion and 2 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 6 Jul 2018. 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?
Rapid virological response (undetected HCV RNA after 4 weeks from the begin of antiviral treatment) (time frame: April 2018 to April 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03480269, which also lists 5 linked publications.
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 6 Jul 2018.