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Trial record 16 of 82 for:    GRAZOPREVIR ANHYDROUS AND ELBASVIR

Grazoprevir and Elbasvir Without Ribavirin for 12 Weeks in Patients With HCV-related Cryoglobulinemic Nephropathy (CRYOKID)

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ClinicalTrials.gov Identifier: NCT03433326
Recruitment Status : Not yet recruiting
First Posted : February 14, 2018
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
Anna Linda Zignego, University of Florence

Brief Summary:
CryoKid is a no-profit, multi-center, single-arm, open-label, pilot study. The study aims to evaluate the tolerability of MK-8742 (Elbasvir) / MK-5172 (Grazoprevir) administrated for 12 weeks without Ribavirin in patients with HCV chronic hepatitis (G1b and G4) and cryoglobulinemic nephropathy.

Condition or disease Intervention/treatment
Hepatitis C Cryoglobulinaemic Glomerulonephritis Drug: Elbasvir/Grazoprevir

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 45 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 24 Weeks
Official Title: A Multicenter, Open Label, Pilot Study of MK-5172 (Grazoprevir)/MK-8742 (Elbasvir) Without Ribavirin for 12 Weeks in G1b and G4 Patients With HCV-related Cryoglobulinemic Nephropathy
Estimated Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Ribavirin


Intervention Details:
  • Drug: Elbasvir/Grazoprevir
    Administration of MK-8742 (Elbasvir)/MK-5172 (Grazoprevir) for 12 weeks
    Other Name: MK-8742/MK-5172


Primary Outcome Measures :
  1. SVR12 [ Time Frame: march 2018-october 2018 ]
    Percentage of participants achieving sustained virologic response 12 weeks after completing treatment (SVR12)


Secondary Outcome Measures :
  1. SVR24 [ Time Frame: march 2018-december 2018 ]
    Percentage of participants achieving Sustained Virologic Response 24 weeks after ending study treatment (SVR 24)

  2. Clinical response: improvement or disappearance of MC clinical and biochemical stigmata [ Time Frame: march 2018-december 2018 ]
    Clinical response: improvement or disappearance of MC clinical and biochemical stigmata at the EOT, at week 12 and week 24 of follow-up. Improvement of the renal function at week 4, week 8, EOT at week 12 and week 24 of follow-up.

  3. Tolerability: Number of participants experiencing an adverse event (AE) [ Time Frame: march 2018-may 2018 ]
    Tolerability: Number of participants experiencing an adverse event (AE)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
G1b and G4 patients with HCV-related Cryoglobulinemic Nephropathy
Criteria

Inclusion Criteria:

  1. Informed consent form signed,
  2. Male or female at least 18 years of age at time of Screening.
  3. Chronic infection with Hepatitis C virus G1b
  4. Chronic infection with Hepatitis C virus G4 naïve, and experienced with baseline HCV RNA level <800,000 IU/ml
  5. Metavir score ranging between F0-F4 (with Child-Pugh score ranging from A5 to A6)
  6. Diagnosis of mixed cryoglobulinemia MC (type III or II) according to standard criteria
  7. Chronic renal impairment due to cryoglobulinemic nephropathy. Subjects with renal impairment will include CKD Stage 5 (eGFR < 15mL/min or dialysis dependent), CKD Stage 4 (eGFR 15-29 mL/min), CKD Stage 3 eGFR (30-59 mL/min) and CKD Stage 2 (60-89 mL/min) HCV patients.
  8. Albumin level ≥ 3.0 g/dl,
  9. Platelet count ≥ 75 x 103/μL.

Exclusion Criteria:

  1. Age <18 years
  2. Chronic infection with Hepatitis C virus G4 experienced with baseline HCV RNA level >800,000 IU/ml
  3. Patients with HCV genotype 1a, 2, 3, 5, 6,
  4. Coexistence of life-threatening condition(s) unrelated to MC
  5. Diagnosis of malignancy
  6. Pregnancy or breast feeding.
  7. Child-Pugh score > A6
  8. Decompensated cirrhosis or previous decompensation
  9. Platelet count < 75 x 103/μL
  10. Albumin level < 3 g/l
  11. Co-infection with more than one HCV genotype.
  12. Any serious or active medical illness which, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance
  13. HIV or chronic hepatitis B virus (HBV) infection (HBsAg positive)
  14. Known hypersensitivity to Grazoprevir, Elbasvir or any of its components

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): NCT03433326


Contacts
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Contact: ANNA LINDA ZIGNEGO, MD, PhD +390552758 ext 020 annalinda.zignego@unifi.it
Contact: MONICA MONTI, PhD +390552758 ext 088 monica.monti@unifi.it

Sponsors and Collaborators
University of Florence
Investigators
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Principal Investigator: ANNA LINDA ZIGNEGO, MD, PhD University of Florence

Additional Information:

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Responsible Party: Anna Linda Zignego, professor of internal medicine, University of Florence
ClinicalTrials.gov Identifier: NCT03433326     History of Changes
Other Study ID Numbers: 56086
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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MK-5172
Hepatitis C
Glomerulonephritis
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Kidney Diseases
Urologic Diseases
Nephritis
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents