Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Trial to eLiminate HCV-infection in Treatment-naïve, Renally Impaired EgyptiAn Patients on Renal Dialysis, With Chronic Hepatitis C Genotype 4 (CLEAR-C4)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03381859
Recruitment Status : Not yet recruiting
First Posted : December 22, 2017
Last Update Posted : November 8, 2019
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Cairo University
Information provided by (Responsible Party):
Shyamasundaran Kottilil, University of Maryland, Baltimore

Brief 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 (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

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Infection, Response to Therapy of Drug: Elbasvir/Grazoprevir 50 MG-100 MG Oral Tablet [ZEPATIER] Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Arm
Patients to receive 12 weeks of Elbasvir (50mg) / Grazoprevir (100mg)
Drug: Elbasvir/Grazoprevir 50 MG-100 MG Oral Tablet [ZEPATIER]
Hepatitis C Virus direct-acting antiviral




Primary Outcome Measures :
  1. SVR12 [ Time Frame: 24 weeks from treatment initiation date ]
    absence of HCV plasma RNA 12 weeks after end of treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed and dated informed consent obtained before undergoing any trial-related procedures
  2. Male and female patients; age between 21 and 70 years inclusive
  3. Chronic hepatitis C infection with genotype 4 confirmed by genotypic testing at screening or within 6 months of screening period
  4. Treatment naïve - absence of prior failed treatment for HCV with Interferon plus ribavirin therapy or directly acting antivirals (treatment experienced)
  5. Detectable HCV viral load (quantitative)
  6. Liver cirrhosis subjects may be included but will be limited to those with compensated liver disease
  7. 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)
  8. Screening laboratory values within the defined protocol thresholds
  9. 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.
  10. Ability to communicate, participate, and comply with the requirements of the entire study

Exclusion Criteria:

  1. Patients didn't sign informed consent or under age of legal consent
  2. Pregnant or breastfeeding woman
  3. Has HCV genotypes other than G4
  4. On peritoneal dialysis for management of kidney disease
  5. Co-Infection with HIV and/or HBV (with positive HBsAg)
  6. Evidence of hepatocellular carcinoma (HCC)
  7. 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
  8. 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
  9. Organ transplant (including hematopoietic stem cell transplant) other than kidney, cornea, and hair
  10. Conditions requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial
  11. Uncontrolled or poorly controlled hypertension
  12. Pregnant, breast-feeding, expecting to conceive or donate eggs, or donate sperm from Day 1 through 14 days after the last study dose.
  13. Significant cardiovascular disorder (e.g. myocardial infarction or unstable angina) or interventional cardiovascular procedure within 3 months prior to signing informed consent
  14. 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
  15. ALT or AST > 10-fold the upper limit of normal
  16. Evidence of liver disease due to causes other than chronic HCV infection
  17. Evidence of poorly controlled diabetes (defined as HbA1c > 8%)
  18. History of alcohol or drug abuse within the last 12 months
  19. Serum albumin level < 3.0 g/dL
  20. INR > 1.3 N
  21. Total Bilirubin levels > 2.0 mg/dL unless explained by Gilbert's disease
  22. Platelets Count <75,000/µL
  23. White blood cell count < 1500 µL (mm3)
  24. Clinically significant TSH and T4 level poorly controlled thyroid function
  25. 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
  26. Body Mass Index < 18.5 or > 35 kg/m2
  27. Use of other investigational drugs/treatments within the previous 3 months
  28. Known hypersensitivity to any of the test materials or related compounds.
  29. Active autoimmune disease.
  30. History of moderate, severe or uncontrolled psychiatric disease, especially severe depression and prior suicidal attempt.
  31. Unable to comply with research study visits.
  32. Poor venous access not allowing screening laboratory collection.
  33. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03381859


Contacts
Layout table for location contacts
Contact: Mohamed Negm, MD +201069920756 negm@bu.edu
Contact: Rabab Fouad, MD +201069920756

Locations
Layout table for location information
Egypt
Kasr Alainy Hospital Not yet recruiting
Cairo, Almanial, Egypt
Contact: Rabab Fouad, MD    +201069920756      
Sponsors and Collaborators
University of Maryland, Baltimore
Merck Sharp & Dohme Corp.
Cairo University
Investigators
Layout table for investigator information
Principal Investigator: Shyamasundaran Kottilil, MD, PhD University of Maryland, College Park

Layout table for additonal information
Responsible Party: Shyamasundaran Kottilil, Professor of Medicine, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT03381859     History of Changes
Other Study ID Numbers: HP-00076974
First Posted: December 22, 2017    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Shyamasundaran Kottilil, University of Maryland, Baltimore:
Hepatitis C Virus
Genotype 4
End Stage Renal Disease
Additional relevant MeSH terms:
Layout table for MeSH terms
MK-5172
Elbasvir-grazoprevir drug combination
Infection
Communicable Diseases
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Antiviral Agents
Anti-Infective Agents