Chronic Hepatitis cPhase 2NCT03067883
Efficacy and Safety of Qurevo Plus Ribavirin Based Therapy for Hepatitis C With or Without Cirrhosis in Haemodialysis Patients
A Phase 2 study testing Ombitasvir, Paritaprevir and Ritonavir in people with Chronic Hepatitis c, run by Ain Shams University at 1 site in Egypt.
Trial summary
To evaluate efficacy and safety of Ombitasvir, paritaprevir, and ritonavir plus ribavirin based therapy for chronic hepatitis C with or without compensated cirrhosis in haemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis c
- What is being tested?
- Ombitasvir, Paritaprevir and Ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Nov 2016to Jul 2018
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Under regular HD for at least 6 months
- Clinically stable condition as outpatients.
- Treatment naïve patients with serum positive for HCV GT4 with HCV RNA > 1000 IU/ml by PCR.
- White blood cell count > 2500/mm^3.
- Platelet count > 7500/mm^3.
- Patients categorised as having compensated cirrhosis had a diagnosis of cirrhosis based on a previous screening liver FibroTest score of 0·72 or lower (eg, Metavir Fibrosis Score >3 [including 3/4 or 3-4] ).
Who cannot join
- Confirmed pregnancy.
- HCV-HIV co infection.
- HBV-HCV co infection.
- Uncontrolled hyper or hypothyroidism.
- For patients without cirrhosis, Patients will be excluded if alanine or aspartate aminotransferase more than five times the upper limit of normal, for patients with cirrhosis they will be excluded if alanine or aspartate aminotransferase are higher than seven times the upper limit of normal
- Patients on peritoneal dialysis.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Maadi armed forces hospital
Cairo, Maadi
Maadi armed forces hospital, 002025265127
About this study
Official title: Evaluation of Efficacy and Safety of Ombitasvir, Paritaprevir, and Ritonavir Plus Ribavirin Based Therapy for Chronic Hepatitis C With or Without Compensated Cirrhosis in Haemodialysis Patients
To evaluate efficacy and safety of Ombitasvir, paritaprevir, and ritonavir plus ribavirin based therapy for chronic hepatitis C with or without compensated cirrhosis in haemodialysis patients.
Read the detailed description
The aim of this study is;
To evaluate the efficacy and safety of ombitasvir, paritaprevir, and ritonavir based therapy for chronic hepatitis C with or without compensated cirrhosis in HCV treatment naïve patients receiving long-term haemodialysis through assessment of:
- The proportion of patients with a sustained virological response (HCV RNA <25 IU/mL) 12 weeks after the last dose of study drug (SVR12).
- To determine withdrawal rate related to side effects and /or adverse effects for patients receiving at least 1 dose of the study medication.
- Conditions
- Chronic Hepatitis c
- Being tested
- Ombitasvir, Paritaprevir and Ritonavir
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ombitasvir, Paritaprevir and RitonavirDrug
Also called qurevo
A total of 40 HCV treatment naïve patients with or without compensated cirrhosis on regular hemodialysis will be enrolled in the study.
- These patients will receive an intervention of '25 mg ombitasvir, 150 mg paritaprevir, and 100 mg ritonavir' (2 capsules Qurevo®) plus ribavirin 200 mg daily for 12 weeks.
- Qurevo will be given once daily (on the day of dialysis, it will be given after dialysis session).
- Ribavirin will be given once daily (on the day of dialysis, it will be given 4 hrs before dialysis session ).
| Study group | Role | What they receive |
|---|---|---|
| interventional Qurevo group | Experimental | A total of 40 HCV treatment naïve patients with or without compensated cirrhosis on regular hemodialysis will be enrolled in the study.
* These patients will receive intervention of '25 mg ombitasvir, 150 mg paritaprevir, and 100 mg ritonavir' (2 capsules Qurevo®) plus ribavirin 200 mg daily for 12 weeks.
* Qurevo will be given once daily (on the day of dialysis, it will be given after dialysis session).
* Ribavirin will be given once daily (on the day of dialysis, it will be given 4 hrs before dialysis session ). Receives: Drug: Ombitasvir, Paritaprevir and Ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Virological Response
The proportion of patients with a sustained virological response (HCV RNA <25 IU/mL) 12 weeks after the last dose of study drug (SVR12).
Measured: After 12 weeks after the last dose
Secondary outcomes (1)
Treatment related withdrawal rate
To determine withdrawal rate related to side effects and /or adverse effects for patients receiving at least 1 dose of the study medication.
Measured: during treatment period, average duration 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start9 Nov 2016
- Primary completionJan 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis cStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, cohort, open label trial
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Mohamed Naguib Abdelmen'em Mohamed, Ain Shams University
- Investigators
- Mai Mohamed Naguib Abd Elmen'em, B.pharm, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03067883
- Sponsor's protocol ID
- Master (No 142)
- Status last verified
- Jan 2018
- First submitted
- 23 Jan 2017
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Safety of Ombitasvir, Paritaprevir, and Ritonavir Plus Ribavirin Based Therapy for Chronic Hepatitis C With or Without Compensated Cirrhosis in Haemodialysis Patients
- ClinicalTrials.gov ID
- NCT03067883
- Acronym / sponsor ID
- Master (No 142)
- Conditions
- Chronic Hepatitis c
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 9 Nov 2016 (actual)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 1 Mar 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 evaluate efficacy and safety of Ombitasvir, paritaprevir, and ritonavir plus ribavirin based therapy for chronic hepatitis C with or without compensated cirrhosis in haemodialysis patients.
Detailed description
The aim of this study is;
To evaluate the efficacy and safety of ombitasvir, paritaprevir, and ritonavir based therapy for chronic hepatitis C with or without compensated cirrhosis in HCV treatment naïve patients receiving long-term haemodialysis through assessment of:
- The proportion of patients with a sustained virological response (HCV RNA <25 IU/mL) 12 weeks after the last dose of study drug (SVR12).
- To determine withdrawal rate related to side effects and /or adverse effects for patients receiving at least 1 dose of the study medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, cohort, open label trial
| Arm | Type | Receives |
|---|---|---|
| interventional Qurevo group | Experimental | Drug: Ombitasvir, Paritaprevir and RitonavirA total of 40 HCV treatment naïve patients with or without compensated cirrhosis on regular hemodialysis will be enrolled in the study. * These patients will receive intervention of '25 mg ombitasvir, 150 mg paritaprevir, and 100 mg ritonavir' (2 capsules Qurevo®) plus ribavirin 200 mg daily for 12 weeks. * Qurevo will be given once daily (on the day of dialysis, it will be given after dialysis session). * Ribavirin will be given once daily (on the day of dialysis, it will be given 4 hrs before dialysis session ). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Under regular HD for at least 6 months
- Clinically stable condition as outpatients.
- Treatment naïve patients with serum positive for HCV GT4 with HCV RNA > 1000 IU/ml by PCR.
- White blood cell count > 2500/mm^3.
- Platelet count > 7500/mm^3.
Key exclusion criteria (6 listed)
- Confirmed pregnancy.
- HCV-HIV co infection.
- HBV-HCV co infection.
- Uncontrolled hyper or hypothyroidism.
- For patients without cirrhosis, Patients will be excluded if alanine or aspartate aminotransferase more than five times the upper limit of normal, for patients with cirrhosis they will be excluded if alanine or aspartate aminotransferase are higher than seven times the upper limit of normal
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 and RitonavirAlso: qurevoA total of 40 HCV treatment naïve patients with or without compensated cirrhosis on regular hemodialysis will be enrolled in the study. * These patients will receive an intervention of '25 mg ombitasvir, 150 mg paritaprevir, and 100 mg ritonavir' (2 capsules Qurevo®) plus ribavirin 200 mg daily for 12 weeks. * Qurevo will be given once daily (on the day of dialysis, it will be given after dialysis session). * Ribavirin will be given once daily (on the day of dialysis, it will be given 4 hrs before dialysis session ). | Drug | interventional Qurevo group |
Primary outcome
Sustained Virological Response
Time frame: After 12 weeks after the last dose
The proportion of patients with a sustained virological response (HCV RNA <25 IU/mL) 12 weeks after the last dose of study drug (SVR12).
1 secondary outcome
Treatment related withdrawal rate
Time frame: during treatment period, average duration 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
Mai Mohamed Naguib Abd Elmen'em, B.pharm principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ombitasvir, Paritaprevir and Ritonavir in people with Chronic Hepatitis c, run by Ain Shams 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 6 inclusion and 6 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 18 Jan 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained Virological Response (time frame: After 12 weeks after the last dose). 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 18 Jan 2018.