Hepatitis C, ChronicNCT03342261
Benefit of DAA Therapy in HCV Monoinfected and HIV-HCV Coinfected Patients With Mixed Cryoglobulinemia
An observational study of Hepatitis C, Chronic and Mixed Cryoglobulinemia, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Mixed cryoglobulinemia (MC) is common in patients with chronic hepatitis C virus (HCV) infection. Direct-acting antiviral (DAA) regimens are today very effective with sustained virological response rates (SVR12) above 90%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic, Mixed Cryoglobulinemia
- What is being tested?
- DAA treatment
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2017to 1 Nov 2017
- 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: HCV patients with mixed cryoglobulinemia
Who may be able to join
- hepatitis C virus (HCV) infected patients
- symptomatic or asymptomatic mixed cryoglobulinemia
- coinfected or not with HIV
- treated by direct-acting antiviral (DAA) treatment
- at least one cryoglobulin measurement before and after DAA
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benefit of Direct-acting Antiviral Therapy in Hepatitis C Virus (HCV) Monoinfected and HIV-HCV Coinfected Patients With Mixed Cryoglobulinemia
Mixed cryoglobulinemia (MC) is common in patients with chronic hepatitis C virus (HCV) infection. Direct-acting antiviral (DAA) regimens are today very effective with sustained virological response rates (SVR12) above 90%. The objective of this study was to investigate the impact of DAA therapy on cryoglobulin clearance in patients with HCV-associated MC.
Read the detailed description
We focused on HCV patients with or without HIV with MC who had at least one cryoglobulin level assessment before and after DAA therapy and investigated the impact of DAA therapy on cryoglobulin clearance.
- Conditions
- Hepatitis C, Chronic, Mixed Cryoglobulinemia
- Being tested
- DAA treatment
- Medical subject headings
- Hepatitis C, Chronic, Cryoglobulinemia, Familial Mixed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAA treatmentDrug
Also called Treatment with direct-acting antiviral agents
Patients were treated with direct-acting antiviral (DAA) treatment for 12 or 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| HCV patients with mixed cryoglobulinemia | HCV patients with or without HIV presenting a mixed cryoglobulinemia and treated with direct-acting antiviral agents Receives: Drug: DAA treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cryoglobulin level at the end of therapy
The primary outcome was the cryoglobulin level at the end of direct-acting antiviral treatment (week 12 or 24 according to treatment duration)
Measured: End of treatment (12 or 24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start1 Mar 2017
- Primary completion1 Nov 2017
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabien Zoulim, MD, PhD, Study chair, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03342261
- Sponsor's protocol ID
- CRC_GHN_2017_002
- Status last verified
- Nov 2017
- First submitted
- 7 Nov 2017
- Last updated
- 14 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of Direct-acting Antiviral Therapy in Hepatitis C Virus (HCV) Monoinfected and HIV-HCV Coinfected Patients With Mixed Cryoglobulinemia
- ClinicalTrials.gov ID
- NCT03342261
- Acronym / sponsor ID
- CRC_GHN_2017_002
- Conditions
- Hepatitis C, Chronic, Mixed Cryoglobulinemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 14 Nov 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.
Mixed cryoglobulinemia (MC) is common in patients with chronic hepatitis C virus (HCV) infection. Direct-acting antiviral (DAA) regimens are today very effective with sustained virological response rates (SVR12) above 90%. The objective of this study was to investigate the impact of DAA therapy on cryoglobulin clearance in patients with HCV-associated MC.
Detailed description
We focused on HCV patients with or without HIV with MC who had at least one cryoglobulin level assessment before and after DAA therapy and investigated the impact of DAA therapy on cryoglobulin clearance.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCV patients with mixed cryoglobulinemia | – | Drug: DAA treatmentHCV patients with or without HIV presenting a mixed cryoglobulinemia and treated with direct-acting antiviral agents |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HCV patients with mixed cryoglobulinemia
Key inclusion criteria (5 listed)
- hepatitis C virus (HCV) infected patients
- symptomatic or asymptomatic mixed cryoglobulinemia
- coinfected or not with HIV
- treated by direct-acting antiviral (DAA) treatment
- at least one cryoglobulin measurement before and after DAA
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| DAA treatmentAlso: Treatment with direct-acting antiviral agentsPatients were treated with direct-acting antiviral (DAA) treatment for 12 or 24 weeks | Drug | HCV patients with mixed cryoglobulinemia |
Primary outcome
Cryoglobulin level at the end of therapy
Time frame: End of treatment (12 or 24 weeks)
The primary outcome was the cryoglobulin level at the end of direct-acting antiviral treatment (week 12 or 24 according to treatment duration)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
- Individual participant dataSharing planned: No
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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.
Fabien Zoulim, MD, PhD study chair
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, Chronic and Mixed Cryoglobulinemia, run by Hospices Civils de Lyon at 1 site in France.
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 5 inclusion and 1 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: finished, as of the sponsor's last update on 14 Nov 2017. 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 France. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cryoglobulin level at the end of therapy (time frame: End of treatment (12 or 24 weeks)). 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 Nov 2017.