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

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: 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

Tracking Information
First Submitted Date February 8, 2018
First Posted Date February 14, 2018
Last Update Posted Date February 14, 2018
Estimated Study Start Date March 1, 2018
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 8, 2018)
SVR12 [ Time Frame: march 2018-october 2018 ]
Percentage of participants achieving sustained virologic response 12 weeks after completing treatment (SVR12)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: February 8, 2018)
  • SVR24 [ Time Frame: march 2018-december 2018 ]
    Percentage of participants achieving Sustained Virologic Response 24 weeks after ending study treatment (SVR 24)
  • 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.
  • Tolerability: Number of participants experiencing an adverse event (AE) [ Time Frame: march 2018-may 2018 ]
    Tolerability: Number of participants experiencing an adverse event (AE)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Grazoprevir and Elbasvir Without Ribavirin for 12 Weeks in Patients With HCV-related Cryoglobulinemic Nephropathy
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
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 24 Weeks
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population G1b and G4 patients with HCV-related Cryoglobulinemic Nephropathy
Condition
  • Hepatitis C
  • Cryoglobulinaemic Glomerulonephritis
Intervention Drug: Elbasvir/Grazoprevir
Administration of MK-8742 (Elbasvir)/MK-5172 (Grazoprevir) for 12 weeks
Other Name: MK-8742/MK-5172
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: February 8, 2018)
45
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2018
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: ANNA LINDA ZIGNEGO, MD, PhD +390552758 ext 020 annalinda.zignego@unifi.it
Contact: MONICA MONTI, PhD +390552758 ext 088 monica.monti@unifi.it
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03433326
Other Study ID Numbers 56086
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Anna Linda Zignego, University of Florence
Study Sponsor University of Florence
Collaborators Not Provided
Investigators
Principal Investigator: ANNA LINDA ZIGNEGO, MD, PhD University of Florence
PRS Account University of Florence
Verification Date February 2018