Hepatitis CNCT03318887
Impact of Sofosbuvir and Daclatasvir Concentration on HCV RNA
An observational study of Hepatitis C, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Sofosbuvir plus daclatasvir with or without ribavirin is one of the currently recommended treatment option for chronic hepatitis C. The objectives were to identify factors associated with sofosbuvir/daclatasvir plasma concentrations variations and to evaluate their impact on viral kinetics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Sofosbuvir/daclatasvir with or without ribavirin
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2014to 30 Jun 2015
- 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: All HCV infected patients from the Department of Hepatology, Croix-Rousse Hospital, Lyon, France receiving sofosbuvir/daclatasvir with or without ribavirin between February and September 2014 were considered
Who may be able to join
- Patients with hepatitis C virus infection treated with sofosbuvir/daclatasvir
- Patients with at least one measurement of sofosbuvir or daclatasvir plasma concentration
- Follow-up of at least 3 months after the end of treatment
Who cannot join
- Patients with severe renal failure (estimated glomerular filtration rate (eGFR)<30ml/min/1.73m2)
- Patients with liver transplantation during therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sofosbuvir Plus Daclatasvir With or Without Ribavirin for Chronic Hepatitis C Infection: Impact of Drug Concentration on Viral Load Decay
Sofosbuvir plus daclatasvir with or without ribavirin is one of the currently recommended treatment option for chronic hepatitis C. The objectives were to identify factors associated with sofosbuvir/daclatasvir plasma concentrations variations and to evaluate their impact on viral kinetics.
- Conditions
- Hepatitis C
- Being tested
- Sofosbuvir/daclatasvir with or without ribavirin
- Keywords
- Cirrhosis, Direct acting antiviral agents, Hepatitis C, Pharmacological monitoring
- Medical subject headings
- Hepatitis C, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sofosbuvir/daclatasvir with or without ribavirinDrug
Also called Combination of sofosbuvir and daclatasvir with or without ribavirin
Direct-acting antiviral treatment for hepatitis C virus infection
| Study group | Role | What they receive |
|---|---|---|
| Sofosbuvir/daclatasvir | Patients with hepatitis C virus (HCV) infection treated with sofosbuvir/daclatasvir combination therapy with or without ribavirin between February and September 2014 Receives: Drug: Sofosbuvir/daclatasvir with or without ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sofosbuvir/daclatasvir plasma concentration
Measured: Sofosbuvir/daclatasvir plasma concentrations were measured at week 4, 8, 12 and 24 during therapy
Secondary outcomes (1)
HCV viral load
Measured: At treatment initiation, at week 4, 8, 12 and 24 of therapy and 12 weeks after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start1 Feb 2014
- Primary completion30 Sep 2014
- Study completion30 Jun 2015
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.
- 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
- 130 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, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03318887
- Sponsor's protocol ID
- CRC_GHN_2016_001
- Status last verified
- Oct 2017
- First submitted
- 19 Oct 2017
- Last updated
- 24 Oct 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 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sofosbuvir Plus Daclatasvir With or Without Ribavirin for Chronic Hepatitis C Infection: Impact of Drug Concentration on Viral Load Decay
- ClinicalTrials.gov ID
- NCT03318887
- Acronym / sponsor ID
- CRC_GHN_2016_001
- Conditions
- Hepatitis C
- Keywords
- Cirrhosis, Direct acting antiviral agents, Hepatitis C, Pharmacological monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Feb 2014 (actual)
- Primary completion
- 30 Sep 2014 (actual)
- Study completion
- 30 Jun 2015 (actual)
- First posted
- 24 Oct 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.
Sofosbuvir plus daclatasvir with or without ribavirin is one of the currently recommended treatment option for chronic hepatitis C. The objectives were to identify factors associated with sofosbuvir/daclatasvir plasma concentrations variations and to evaluate their impact on viral kinetics.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sofosbuvir/daclatasvir | – | Drug: Sofosbuvir/daclatasvir with or without ribavirinPatients with hepatitis C virus (HCV) infection treated with sofosbuvir/daclatasvir combination therapy with or without ribavirin between February and September 2014 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All HCV infected patients from the Department of Hepatology, Croix-Rousse Hospital, Lyon, France receiving sofosbuvir/daclatasvir with or without ribavirin between February and September 2014 were considered
Key inclusion criteria (3 listed)
- Patients with hepatitis C virus infection treated with sofosbuvir/daclatasvir
- Patients with at least one measurement of sofosbuvir or daclatasvir plasma concentration
- Follow-up of at least 3 months after the end of treatment
Key exclusion criteria (2 listed)
- Patients with severe renal failure (estimated glomerular filtration rate (eGFR)<30ml/min/1.73m2)
- Patients with liver transplantation during therapy
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 |
|---|---|---|
| Sofosbuvir/daclatasvir with or without ribavirinAlso: Combination of sofosbuvir and daclatasvir with or without ribavirinDirect-acting antiviral treatment for hepatitis C virus infection | Drug | Sofosbuvir/daclatasvir |
Primary outcome
Sofosbuvir/daclatasvir plasma concentration
Time frame: Sofosbuvir/daclatasvir plasma concentrations were measured at week 4, 8, 12 and 24 during therapy
1 secondary outcome
HCV viral load
Time frame: At treatment initiation, at week 4, 8, 12 and 24 of therapy and 12 weeks after the end of treatment
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 24 Oct 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 principal investigator
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, 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 3 inclusion and 2 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 24 Oct 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?
Sofosbuvir/daclatasvir plasma concentration (time frame: Sofosbuvir/daclatasvir plasma concentrations were measured at week 4, 8, 12 and 24 during therapy). 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 24 Oct 2017.