Hepatitis C Virus Infection, Response to Therapy ofPhase 4CLEAR-C4NCT03381859
Clinical Trial to eLiminate HCV-infection in Treatment-naïve, Renally Impaired EgyptiAn Patients on Renal Dialysis, With Chronic Hepatitis C Genotype 4
A Phase 4 study testing Elbasvir/Grazoprevir 50 MG-100 MG Oral Tablet [ZEPATIER] in people with Hepatitis C Virus Infection, Response to Therapy of, run by University of Maryland, Baltimore at 1 site in Egypt.
Trial summary
Primary Efficacy Objective -To assess whether a 12-week treatment course with oral 50 mg elbasvir plus 100 mg grazoprevir given in a single daily dose to treatment-naïve patients with end-stage renal disease (ESRD) and infected with genotype 4 (GT4) chronic HCV (CHC) infection can produce a sustained viral response… Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Hepatitis C Virus Infection, Response to Therapy of
- What is being tested?
- Elbasvir/Grazoprevir 50 MG-100 MG Oral Tablet [ZEPATIER]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2019to 1 Jun 2020
- Phase
- Phase 4
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent obtained before undergoing any trial-related procedures
- Male and female patients; age between 21 and 70 years inclusive
- Chronic hepatitis C infection with genotype 4 confirmed by genotypic testing at screening or within 6 months of screening period
- Treatment naïve - absence of prior failed treatment for HCV with Interferon plus ribavirin therapy or directly acting antivirals (treatment experienced)
- Detectable HCV viral load (quantitative)
- Liver cirrhosis subjects may be included but will be limited to those with compensated liver disease
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- Chronic kidney disease with end-stage liver disease (defined as glomerular filtration rate [eGFR] <=15 mL/min/1.73m2) on hemodialysis for at least 3 months, including individuals awaiting kidney transplant and those with failed kidney transplants but no longer on immunosuppressant therapy)
- Screening laboratory values within the defined protocol thresholds
- Women of child-bearing potential, must agree to abstinence or use of effective contraceptive methods (e.g. oral or injectable contraceptives, intra-uterine device (IUD), transdermal contraceptive patch) at least 2 weeks prior Day 1 through 14 days after the last dose of the study drug.
- Ability to communicate, participate, and comply with the requirements of the entire study
Who cannot join
- Patients didn't sign informed consent or under age of legal consent
- Pregnant or breastfeeding woman
- Has HCV genotypes other than G4
- On peritoneal dialysis for management of kidney disease
- Co-Infection with HIV and/or HBV (with positive HBsAg)
- Evidence of hepatocellular carcinoma (HCC)
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- Evidence of hepatic decompensation as evidenced by presence or history of ascites, esophaegal or gastric bleeding, hepatic encelopathy or other signs of or symptoms of advanced liver disease, or cirrhotic subjects with Child-Pugh B or C, or who have a Purgh-Turcotte (CPT) score >6
- Active or suspected non-hepatic malignancy or history of any malignancy except for cured basal cell or squamous cell skin cancer or in situ cervical cancer
- Organ transplant (including hematopoietic stem cell transplant) other than kidney, cornea, and hair
- Conditions requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial
- Uncontrolled or poorly controlled hypertension
- Pregnant, breast-feeding, expecting to conceive or donate eggs, or donate sperm from Day 1 through 14 days after the last study dose.
- Significant cardiovascular disorder (e.g. myocardial infarction or unstable angina) or interventional cardiovascular procedure within 3 months prior to signing informed consent
- Recent (within 3 months prior to signing informed consent) episode or recurrence of stroke, transient ischemic attack (TIA) or neurological disorder, including but not limited to seizures
- ALT or AST > 10-fold the upper limit of normal
- Evidence of liver disease due to causes other than chronic HCV infection
- Evidence of poorly controlled diabetes (defined as HbA1c > 8%)
- History of alcohol or drug abuse within the last 12 months
- Serum albumin level < 3.0 g/dL
- INR > 1.3 N
- Total Bilirubin levels > 2.0 mg/dL unless explained by Gilbert's disease
- Platelets Count <75,000/µL
- White blood cell count < 1500 µL (mm3)
- Clinically significant TSH and T4 level poorly controlled thyroid function
- Patients with any abnormality on physical examination, vital signs (sitting systolic blood pressure greater than 150 mmHg, sitting diastolic blood pressure greater than 90 mmHg and pulse greater than 90 bpm) and ECG, unless these abnormalities are judged to be not clinically significant by the Investigator
- Body Mass Index < 18.5 or > 35 kg/m2
- Use of other investigational drugs/treatments within the previous 3 months
- Known hypersensitivity to any of the test materials or related compounds.
- Active autoimmune disease.
- History of moderate, severe or uncontrolled psychiatric disease, especially severe depression and prior suicidal attempt.
- Unable to comply with research study visits.
- Poor venous access not allowing screening laboratory collection.
- Any other condition that, in the opinion of the Investigator, may be a contraindication to study participation or jeopardize the study conduct according to the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-site, Open-label, Non-comparator Clinical Trial to eLiminate HCV-infection in Treatment-naïve, EgyptiAn Patients With End-stage Renal Disease on Renal Dialysis, With Chronic Hepatitis C Genotype 4 Infection Using a 12-week Course of Once-daily Single Oral Tablet of Elbasvir (50mg)/Grazoprevir (100 mg)
Primary Efficacy Objective
-To assess whether a 12-week treatment course with oral 50 mg elbasvir plus 100 mg grazoprevir given in a single daily dose to treatment-naïve patients with end-stage renal disease (ESRD) and infected with genotype 4 (GT4) chronic HCV (CHC) infection can produce a sustained viral response (SVR), i.e. HCV RNA below the lower limit of quantification [LLOQ] for 12 weeks (SVR12) after completion of the study treatment course
Read more
Secondary Objectives
- To assess the efficacy of elbasvir/grazoprevir in suppressing HCV viremia in treatment-naïve GT4 CHC patients at each scheduled visit and clinically meaningful endpoints (Week 2, 8 and 12 [End of Treatment - EOT]) and 24 (SVR12)
- To assess the safety and tolerability of a 12-week treatment course with elbasvir/grazoprevir in treatment-naïve patients with ESRD and infected with GT4 CHC.
- To assess liver fibrosis by non-invasive evaluation of liver stiffness (Fibroscan®) in the same patients before treatment and EOT and SVR12
Clinical hypotheses.
Primary Efficacy Hypothesis
- A 12-week treatment course with elbasvir/grazoprevir in treatment-naïve patients with ESRD and infected with GT4 CHC infection will result in an HCV RNA below the LLOQ in 95% of patients within 2 weeks of treatment, and at least 95% will have an SVR12.
Secondary hypotheses
- A 12-week treatment course with elbasvir/grazoprevir in ESRD GT4 treatment-naïve patients will result in undetectable viremia in 95% patients at Week 2, 4, 8 and 12 (EOT) and 24 (SVR12)
- Treatment will be safe and well-tolerated in these patients, as determined by the type and number of adverse events identified through laboratory testing, vital signs and physical examinations.
- In these patients with liver fibrosis before treatment, the liver fibrosis as assessed by non-invasive evaluation of liver stiffness (Fibroscan®) will improve by EOT and SVR12
- Being tested
- Elbasvir/Grazoprevir 50 MG-100 MG Oral Tablet [ZEPATIER]
- Keywords
- Hepatitis C Virus, Genotype 4, End Stage Renal Disease
- Medical subject headings
- Hepatitis C, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elbasvir/Grazoprevir 50 MG-100 MG Oral Tablet [ZEPATIER]Drug
Hepatitis C Virus direct-acting antiviral
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Patients to receive 12 weeks of Elbasvir (50mg) / Grazoprevir (100mg) Receives: Drug: Elbasvir/Grazoprevir 50 MG-100 MG Oral Tablet [ZEPATIER] |
What is being measured
The primary outcome is the main question the study is designed to answer.
SVR12
absence of HCV plasma RNA 12 weeks after end of treatment
Measured: 24 weeks from treatment initiation date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start1 Dec 2019 (estimated)
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Why it stopped: HCV treatment expansion occurred in Egypt
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C Virus Infection, Response to Therapy ofStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Cairo University
- Responsible party
- Principal investigator, Shyamasundaran Kottilil, University of Maryland, Baltimore
- Investigators
- Shyamasundaran Kottilil, MD, PhD, Principal investigator, University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381859
- Sponsor's protocol ID
- HP-00076974
- Acronym
- CLEAR-C4
- Status last verified
- Apr 2020
- First submitted
- 18 Dec 2017
- Last updated
- 20 Apr 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-site, Open-label, Non-comparator Clinical Trial to eLiminate HCV-infection in Treatment-naïve, EgyptiAn Patients With End-stage Renal Disease on Renal Dialysis, With Chronic Hepatitis C Genotype 4 Infection Using a 12-week Course of Once-daily Single Oral Tablet of Elbasvir (50mg)/Grazoprevir (100 mg)
- ClinicalTrials.gov ID
- NCT03381859
- Acronym / sponsor ID
- CLEAR-C4 / HP-00076974
- Keywords
- Hepatitis C Virus, Genotype 4, End Stage Renal Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: HCV treatment expansion occurred in Egypt
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Cairo University
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 22 Dec 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.
Primary Efficacy Objective
-To assess whether a 12-week treatment course with oral 50 mg elbasvir plus 100 mg grazoprevir given in a single daily dose to treatment-naïve patients with end-stage renal disease (ESRD) and infected with genotype 4 (GT4) chronic HCV (CHC) infection can produce a sustained viral response (SVR), i.e. HCV RNA below the lower limit of quantification [LLOQ] for 12 weeks (SVR12) after completion of the study treatment course
Secondary Objectives
- To assess the efficacy of elbasvir/grazoprevir in suppressing HCV viremia in treatment-naïve GT4 CHC patients at each scheduled visit and clinically meaningful endpoints (Week 2, 8 and 12 [End of Treatment - EOT]) and 24 (SVR12)
- To assess the safety and tolerability of a 12-week treatment course with elbasvir/grazoprevir in treatment-naïve patients with ESRD and infected with GT4 CHC.
- To assess liver fibrosis by non-invasive evaluation of liver stiffness (Fibroscan®) in the same patients before treatment and EOT and SVR12
Clinical hypotheses.
Primary Efficacy Hypothesis
- A 12-week treatment course with elbasvir/grazoprevir in treatment-naïve patients with ESRD and infected with GT4 CHC infection will result in an HCV RNA below the LLOQ in 95% of patients within 2 weeks of treatment, and at least 95% will have an SVR12.
Secondary hypotheses
- A 12-week treatment course with elbasvir/grazoprevir in ESRD GT4 treatment-naïve patients will result in undetectable viremia in 95% patients at Week 2, 4, 8 and 12 (EOT) and 24 (SVR12)
- Treatment will be safe and well-tolerated in these patients, as determined by the type and number of adverse events identified through laboratory testing, vital signs and physical examinations.
- In these patients with liver fibrosis before treatment, the liver fibrosis as assessed by non-invasive evaluation of liver stiffness (Fibroscan®) will improve by EOT and SVR12
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Elbasvir/Grazoprevir 50 MG-100 MG Oral Tablet [ZEPATIER]Patients to receive 12 weeks of Elbasvir (50mg) / Grazoprevir (100mg) |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed and dated informed consent obtained before undergoing any trial-related procedures
- Male and female patients; age between 21 and 70 years inclusive
- Chronic hepatitis C infection with genotype 4 confirmed by genotypic testing at screening or within 6 months of screening period
- Treatment naïve - absence of prior failed treatment for HCV with Interferon plus ribavirin therapy or directly acting antivirals (treatment experienced)
- Detectable HCV viral load (quantitative)
Key exclusion criteria (33 listed)
- Patients didn't sign informed consent or under age of legal consent
- Pregnant or breastfeeding woman
- Has HCV genotypes other than G4
- On peritoneal dialysis for management of kidney disease
- Co-Infection with HIV and/or HBV (with positive HBsAg)
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 |
|---|---|---|
| Elbasvir/Grazoprevir 50 MG-100 MG Oral Tablet [ZEPATIER]Hepatitis C Virus direct-acting antiviral | Drug | Treatment Arm |
Primary outcome
SVR12
Time frame: 24 weeks from treatment initiation date
absence of HCV plasma RNA 12 weeks after end of treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- Individual participant dataSharing planned: No
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RecruitingObservational study
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Hepatitis C, Transmission, Intravenous Drug Abuser
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.
Shyamasundaran Kottilil, MD, PhD principal investigator
University of Maryland, College Park
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Elbasvir/Grazoprevir 50 MG-100 MG Oral Tablet [ZEPATIER] in people with Hepatitis C Virus Infection, Response to Therapy of, run by University of Maryland, Baltimore 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 10 inclusion and 33 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: withdrawn, as of the sponsor's last update on 20 Apr 2020. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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?
SVR12 (time frame: 24 weeks from treatment initiation date). 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 20 Apr 2020.