Hepatitis CPhase 1NCT03341988
Evaluation of Treatment of Chronic HCV Patients in Chronic Kidney Disease Versus End Stage Renal Disease Patients
A Phase 1 study testing Ombitasvir-Paritaprevir-Ritonavir Tab 12.5-75-50 milligram in people with Hepatitis C, run by Assiut University at 1 site in Egypt.
Trial summary
1. To asses curability of( Ombitasvir ,Paritaprevir,Ritonavir) in chronic HCV infected patients in those with CKD versus ESRD in Assiut Hospital University . 2. Also assess duration of sustained viral response,treatment, relapse or failure of therapy in CKD versus ESRD in Assiut Hospital. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Ombitasvir-Paritaprevir-Ritonavir Tab 12.5-75-50 milligram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Nov 2017to 1 May 2018
- Phase
- Phase 1
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The patients aged from18- 60 years.
- Chronic HCV infection with Plasma HCV RNA greater than 15,000 IU/mL
- Treatment naïve.
- compensated liver cirrhosis.
- Absence of coinfection with HBV or HIV.
Who cannot join
- Patients with hepatitis B virus or HIV.
- prior antiviral therapy.
- Haemoglobin level less than 10mg/dl.
- Decompensated liver disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Clinical Effects of Ombitasvir/Paritaprevir/Ritonavir Regimen in the Treatment of Chronic HCV Patients in CKD Versus ESRD Patients in Assiut University Hospital
- To asses curability of( Ombitasvir ,Paritaprevir,Ritonavir) in chronic HCV infected patients in those with CKD versus ESRD in Assiut Hospital University .
- Also assess duration of sustained viral response,treatment, relapse or failure of therapy in CKD versus ESRD in Assiut Hospital.
Read the detailed description
Hepatitis C virus (HCV) is a leading cause of liver disease worldwide, as 130-170 million individuals are chronically infected and 350,000 patients die every year from HCV infection. The HCV prevalence varies widely among countries being highest in several African and Eastern Mediterranean countries. So public health authorities should recognise the importance of HCV and make resources available for the implementation of effective primary prevention, screening and management policies .
The hepatitis C virus (HCV) genotype is an important predictor of disease progression and treatment response. Genotype 1b has a worldwide distribution and is often found to be the most common genotype. HCV-genotype 4 causes approximately 20% of the 180 million cases of chronic hepatitis C in the world, is predominant in the Middle East and Northern Africa, and has recently spread to Southern Europe. Genotype 4 accounts for more than 90% of the reported cases from Egypt, a country with a massive HCV-related disease burden.
The prevalence of anti-hepatitis C virus Ab (anti-HCV) positivity among dialysis patients varies across countries, ranging from 3 to 75%; unfortunately, Egypt is considered one of the countries with the highest prevalence despite the existence of guidelines for a comprehensive infection control program.
In Egypt In the 15-59-year age groups, the prevalence of HCV antibody was found to be 10.0% and that of HCV RNA to be 7.0%. Approximately, 3.7 million persons have chronic HCV infection in the age group 15-59 in 2015.
In the treatment of chronic HCV in renal impairment For patients with mild to moderate renal impairment (CrCl 30 mL/min-80 mL/min), no dosage adjustment is required when using fixed-dose combination of paritaprevir (150 mg)/ritonavir (100 mg)/ombitasvir (25 mg) .
Abbvie's 2D regimen (paritaprevir (150 mg)/ritonavir (100 mg)/ombitasvir(25mg)) was recently approved with specific indication for genotype 4 treatment naïve and experienced patients without cirrhosis achieved an sustained viral response rate of 100% following 12 weeks of 2D regimen with RBV, 2D can be used without RBV but may have slightly lower SVR (91% vs 100%). Currently, there is no FDA indication for 2D regimen use in patients with cirrhosis.
. Ombitasvir (25 mg once daily), Paritaprevir (150 mg once daily), Ritonavir (100 mg once daily)Ribavirin (RBV): weight-based and divided bid (1000 mg/day if < 75kg or 1200 mg/day if ≥ 75kg) .
- Conditions
- Hepatitis C
- Being tested
- Ombitasvir-Paritaprevir-Ritonavir Tab 12.5-75-50 milligram
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ombitasvir-Paritaprevir-Ritonavir Tab 12.5-75-50 milligramDrug
To asses curability of( Ombitasvir ,Paritaprevir,Ritonavir) in ch HCV infected patients in those with CKD vs ESRD 2- Also assess duration of sustained viral response,treatment, relapse or failure of therapy in CKD vs ESRD
| Study group | Role | What they receive |
|---|---|---|
| Ombitasvir (25 mg ), Paritaprevir (150 mg ) once daily | Other | Ombitasvir (25 mg once daily), Paritaprevir (150 mg once daily), Ritonavir (100 mg once daily)Ribavirin (RBV): weight-based and divided bid (1000 mg/day if < 75kg or 1200 mg/day if ≥ 75kg) given to 50 chronic HCV infected patients with renal impairment for 12 week Receives: Drug: Ombitasvir-Paritaprevir-Ritonavir Tab 12.5-75-50 milligram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the sustained viral response of Ombitasvir/Paritaprevir/Ritonavir regimen in the treatment of Chronic HCV patients in CKD versus ESRD patients in Assiut University Hospital
pathologic complete remission for HCV after tretment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start22 Nov 2017
- Primary completion1 Jan 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed A Mekky, Assiut University
- Investigators
- Hala Elsherif, Professor, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341988
- Sponsor's protocol ID
- HCV in renal impairment
- Status last verified
- May 2018
- First submitted
- 2 Oct 2017
- Last updated
- 22 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hezode C, Asselah T, Reddy KR, Hassanein T, Berenguer M, Fleischer-Stepniewska K, Marcellin P, Hall C, Schnell G, Pilot-Matias T, Mobashery N, Redman R, Vilchez RA, Pol S. Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): a randomised, open-label trial. Lancet. 2015 Jun 20;385(9986):2502-9. doi: 10.1016/S0140-6736(15)60159-3. Epub 2015 Mar 31.
PubMed 25837829Zhang J, Nguyen D, Hu KQ. Chronic Hepatitis C Virus Infection: A Review of Current Direct-Acting Antiviral Treatment Strategies. N Am J Med Sci (Boston). 2016 Apr;9(2):47-54. Epub 2016 Apr 27.
PubMed 27293521Kandeel A, Genedy M, El-Refai S, Funk AL, Fontanet A, Talaat M. The prevalence of hepatitis C virus infection in Egypt 2015: implications for future policy on prevention and treatment. Liver Int. 2017 Jan;37(1):45-53. doi: 10.1111/liv.13186. Epub 2016 Jun 30.
PubMed 27275625Mekky MA, Abdel-Malek MO, Osman HA, Abdel-Aziz EM, Hashim AA, Hetta HF, Morsy KH. Efficacy of ombitasvir/paritaprevir/ritonavir/ribavirin in management of HCV genotype 4 and end-stage kidney disease. Clin Res Hepatol Gastroenterol. 2019 Feb;43(1):82-87. doi: 10.1016/j.clinre.2018.08.003. Epub 2018 Aug 27.
PubMed 30166253
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Effects of Ombitasvir/Paritaprevir/Ritonavir Regimen in the Treatment of Chronic HCV Patients in CKD Versus ESRD Patients in Assiut University Hospital
- ClinicalTrials.gov ID
- NCT03341988
- Acronym / sponsor ID
- HCV in renal impairment
- Conditions
- Hepatitis C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 22 Nov 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 14 Nov 2017 (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 asses curability of( Ombitasvir ,Paritaprevir,Ritonavir) in chronic HCV infected patients in those with CKD versus ESRD in Assiut Hospital University .
- Also assess duration of sustained viral response,treatment, relapse or failure of therapy in CKD versus ESRD in Assiut Hospital.
Detailed description
Hepatitis C virus (HCV) is a leading cause of liver disease worldwide, as 130-170 million individuals are chronically infected and 350,000 patients die every year from HCV infection. The HCV prevalence varies widely among countries being highest in several African and Eastern Mediterranean countries. So public health authorities should recognise the importance of HCV and make resources available for the implementation of effective primary prevention, screening and management policies .
The hepatitis C virus (HCV) genotype is an important predictor of disease progression and treatment response. Genotype 1b has a worldwide distribution and is often found to be the most common genotype. HCV-genotype 4 causes approximately 20% of the 180 million cases of chronic hepatitis C in the world, is predominant in the Middle East and Northern Africa, and has recently spread to Southern Europe. Genotype 4 accounts for more than 90% of the reported cases from Egypt, a country with a massive HCV-related disease burden.
The prevalence of anti-hepatitis C virus Ab (anti-HCV) positivity among dialysis patients varies across countries, ranging from 3 to 75%; unfortunately, Egypt is considered one of the countries with the highest prevalence despite the existence of guidelines for a comprehensive infection control program.
In Egypt In the 15-59-year age groups, the prevalence of HCV antibody was found to be 10.0% and that of HCV RNA to be 7.0%. Approximately, 3.7 million persons have chronic HCV infection in the age group 15-59 in 2015.
In the treatment of chronic HCV in renal impairment For patients with mild to moderate renal impairment (CrCl 30 mL/min-80 mL/min), no dosage adjustment is required when using fixed-dose combination of paritaprevir (150 mg)/ritonavir (100 mg)/ombitasvir (25 mg) .
Abbvie's 2D regimen (paritaprevir (150 mg)/ritonavir (100 mg)/ombitasvir(25mg)) was recently approved with specific indication for genotype 4 treatment naïve and experienced patients without cirrhosis achieved an sustained viral response rate of 100% following 12 weeks of 2D regimen with RBV, 2D can be used without RBV but may have slightly lower SVR (91% vs 100%). Currently, there is no FDA indication for 2D regimen use in patients with cirrhosis.
. Ombitasvir (25 mg once daily), Paritaprevir (150 mg once daily), Ritonavir (100 mg once daily)Ribavirin (RBV): weight-based and divided bid (1000 mg/day if < 75kg or 1200 mg/day if ≥ 75kg) .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ombitasvir (25 mg ), Paritaprevir (150 mg ) once daily | Other | Drug: Ombitasvir-Paritaprevir-Ritonavir Tab 12.5-75-50 milligramOmbitasvir (25 mg once daily), Paritaprevir (150 mg once daily), Ritonavir (100 mg once daily)Ribavirin (RBV): weight-based and divided bid (1000 mg/day if < 75kg or 1200 mg/day if ≥ 75kg) given to 50 chronic HCV infected patients with renal impairment for 12 week |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The patients aged from18- 60 years.
- Chronic HCV infection with Plasma HCV RNA greater than 15,000 IU/mL
- Treatment naïve.
- compensated liver cirrhosis.
- Absence of coinfection with HBV or HIV.
Key exclusion criteria (4 listed)
- Patients with hepatitis B virus or HIV.
- prior antiviral therapy.
- Haemoglobin level less than 10mg/dl.
- Decompensated liver disease.
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 |
|---|---|---|
| Ombitasvir-Paritaprevir-Ritonavir Tab 12.5-75-50 milligramTo asses curability of( Ombitasvir ,Paritaprevir,Ritonavir) in ch HCV infected patients in those with CKD vs ESRD 2- Also assess duration of sustained viral response,treatment, relapse or failure of therapy in CKD vs ESRD | Drug | Ombitasvir (25 mg ), Paritaprevir (150 mg ) once daily |
Primary outcome
Evaluation of the sustained viral response of Ombitasvir/Paritaprevir/Ritonavir regimen in the treatment of Chronic HCV patients in CKD versus ESRD patients in Assiut University Hospital
Time frame: 6 months
pathologic complete remission for HCV after tretment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
- Background: PubMed 25837829Hezode C, Asselah T, Reddy KR, Hassanein T, Berenguer M, Fleischer-Stepniewska K, Marcellin P, Hall C, Schnell G, Pilot-Matias T, Mobashery N, Redman R, Vilchez RA, Pol S. Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): a randomised, open-label trial. Lancet. 2015 Jun 20;385(9986):2502-9. doi: 10.1016/S0140-6736(15)60159-3. Epub 2015 Mar 31.
- Background: PubMed 27293521Zhang J, Nguyen D, Hu KQ. Chronic Hepatitis C Virus Infection: A Review of Current Direct-Acting Antiviral Treatment Strategies. N Am J Med Sci (Boston). 2016 Apr;9(2):47-54. Epub 2016 Apr 27.
- Background: PubMed 27275625Kandeel A, Genedy M, El-Refai S, Funk AL, Fontanet A, Talaat M. The prevalence of hepatitis C virus infection in Egypt 2015: implications for future policy on prevention and treatment. Liver Int. 2017 Jan;37(1):45-53. doi: 10.1111/liv.13186. Epub 2016 Jun 30.
- Derived from this study: PubMed 30166253Mekky MA, Abdel-Malek MO, Osman HA, Abdel-Aziz EM, Hashim AA, Hetta HF, Morsy KH. Efficacy of ombitasvir/paritaprevir/ritonavir/ribavirin in management of HCV genotype 4 and end-stage kidney disease. Clin Res Hepatol Gastroenterol. 2019 Feb;43(1):82-87. doi: 10.1016/j.clinre.2018.08.003. Epub 2018 Aug 27.
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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.
Hala Elsherif, Professor study chair
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ombitasvir-Paritaprevir-Ritonavir Tab 12.5-75-50 milligram in people with Hepatitis C, run by Assiut University at 1 site in Egypt.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of the sustained viral response of Ombitasvir/Paritaprevir/Ritonavir regimen in the treatment of Chronic HCV patients in CKD versus ESRD patients in Assiut University Hospital (time frame: 6 months). 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 NCT03341988, which also lists 4 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 22 May 2018.