Hepatitis CCRYOKIDNCT03433326
Grazoprevir and Elbasvir Without Ribavirin for 12 Weeks in Patients With HCV-related Cryoglobulinemic Nephropathy
An observational study of Hepatitis C and Cryoglobulinaemic Glomerulonephritis, run by University of Florence.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Cryoglobulinaemic Glomerulonephritis
- What is being tested?
- Elbasvir/Grazoprevir
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2018to 31 Dec 2018
- How long will I take part?
- 24 Weeks
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: G1b and G4 patients with HCV-related Cryoglobulinemic Nephropathy
Who may be able to join
- Informed consent form signed,
- Male or female at least 18 years of age at time of Screening.
- Chronic infection with Hepatitis C virus G1b
- Chronic infection with Hepatitis C virus G4 naïve, and experienced with baseline HCV RNA level <800,000 IU/ml
- Metavir score ranging between F0-F4 (with Child-Pugh score ranging from A5 to A6)
- Diagnosis of mixed cryoglobulinemia MC (type III or II) according to standard criteria
Show all 9Show fewer
- 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.
- Albumin level ≥ 3.0 g/dl,
- Platelet count ≥ 75 x 103/μL.
Who cannot join
- Age <18 years
- Chronic infection with Hepatitis C virus G4 experienced with baseline HCV RNA level >800,000 IU/ml
- Patients with HCV genotype 1a, 2, 3, 5, 6,
- Coexistence of life-threatening condition(s) unrelated to MC
- Diagnosis of malignancy
- Pregnancy or breast feeding.
Show all 14Show fewer
- Child-Pugh score > A6
- Decompensated cirrhosis or previous decompensation
- Platelet count < 75 x 103/μL
- Albumin level < 3 g/l
- Co-infection with more than one HCV genotype.
- Any serious or active medical illness which, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance
- HIV or chronic hepatitis B virus (HBV) infection (HBsAg positive)
- Known hypersensitivity to Grazoprevir, Elbasvir or any of its components
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
- Conditions
- Hepatitis C, Cryoglobulinaemic Glomerulonephritis
- Being tested
- Elbasvir/Grazoprevir
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elbasvir/GrazoprevirDrug
Also called MK-8742/MK-5172
Administration of MK-8742 (Elbasvir)/MK-5172 (Grazoprevir) for 12 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
SVR12
Percentage of participants achieving sustained virologic response 12 weeks after completing treatment (SVR12)
Measured: march 2018-october 2018
Secondary outcomes (3)
SVR24
Percentage of participants achieving Sustained Virologic Response 24 weeks after ending study treatment (SVR 24)
Measured: march 2018-december 2018
Clinical response: improvement or disappearance of MC clinical and biochemical stigmata
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.
Measured: march 2018-december 2018
Tolerability: Number of participants experiencing an adverse event (AE)
Tolerability: Number of participants experiencing an adverse event (AE)
Measured: march 2018-may 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start1 Mar 2018 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
- Target duration
- 24 Weeks
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Linda Zignego, University of Florence
- Investigators
- ANNA LINDA ZIGNEGO, MD, PhD, Principal investigator, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433326
- Sponsor's protocol ID
- 56086
- Acronym
- CRYOKID
- Status last verified
- Feb 2018
- First submitted
- 8 Feb 2018
- Last updated
- 14 Feb 2018
- 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 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03433326
- Acronym / sponsor ID
- CRYOKID / 56086
- Conditions
- Hepatitis C, Cryoglobulinaemic Glomerulonephritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Study start
- 1 Mar 2018 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 14 Feb 2018 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 24 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- G1b and G4 patients with HCV-related Cryoglobulinemic Nephropathy
Key inclusion criteria (9 listed)
- Informed consent form signed,
- Male or female at least 18 years of age at time of Screening.
- Chronic infection with Hepatitis C virus G1b
- Chronic infection with Hepatitis C virus G4 naïve, and experienced with baseline HCV RNA level <800,000 IU/ml
- Metavir score ranging between F0-F4 (with Child-Pugh score ranging from A5 to A6)
Key exclusion criteria (14 listed)
- Age <18 years
- Chronic infection with Hepatitis C virus G4 experienced with baseline HCV RNA level >800,000 IU/ml
- Patients with HCV genotype 1a, 2, 3, 5, 6,
- Coexistence of life-threatening condition(s) unrelated to MC
- Diagnosis of malignancy
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/GrazoprevirAlso: MK-8742/MK-5172Administration of MK-8742 (Elbasvir)/MK-5172 (Grazoprevir) for 12 weeks | Drug | – |
Primary outcome
SVR12
Time frame: march 2018-october 2018
Percentage of participants achieving sustained virologic response 12 weeks after completing treatment (SVR12)
3 secondary outcomes
SVR24
Time frame: march 2018-december 2018
Clinical response: improvement or disappearance of MC clinical and biochemical stigmata
Time frame: march 2018-december 2018
Tolerability: Number of participants experiencing an adverse event (AE)
Time frame: march 2018-may 2018
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
- Individual participant dataSharing planned: No
Related trials for Hepatitis C
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
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.
ANNA LINDA ZIGNEGO, MD, PhD principal investigator
University of Florence
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C and Cryoglobulinaemic Glomerulonephritis, run by University of Florence.
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 9 inclusion and 14 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 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Contact ANNA LINDA ZIGNEGO, MD, PhD (+390552758 ext. 020, annalinda.zignego@unifi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SVR12 (time frame: march 2018-october 2018). 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 14 Feb 2018.