Drug Interaction PotentiationNCT03706222
Drug-Drug Interactions of Grazoprevir/Elbasvir in Taiwan
An observational study of Drug Interaction Potentiation, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
Co-morbid diseases often present in a substantial proportion of patients with chronic hepatitis C (CHC) and require drugs to treat and control. Grazoprevir/elbavir is metabolized by cytochrome P-450 enzyme of liver. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Drug Interaction Potentiation
- What is being tested?
- elbasvir/grazoprevir
- How many people
- 400 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Oct 2018to 25 Feb 2019
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients infected with genotype 1 or 4 hepatitis C virus and treated with elbasvir/grazoprevir during August 2017 to July 2018 in Taiwan.
Who may be able to join
- Patients treated with grazoprevir/elbasvir are candidates of study subjects.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Real World Analysis of Drug-Drug Interactions of Grazoprevir/Elbasvir in Treatment of Chronic Hepatitis C Patients in Taiwan
Co-morbid diseases often present in a substantial proportion of patients with chronic hepatitis C (CHC) and require drugs to treat and control. Grazoprevir/elbavir is metabolized by cytochrome P-450 enzyme of liver. Drug-drug interactions (DDIs) are important issue before commencing direct acting antiviral agents (DAA) treatment for CHC patients. Few studies from Western countries reported that the percentages of DDIs of grazoprevir/elbasvir are limited.In Asia, real-world analysis of DDIs of grazoprevir/elbasvir is lacking and needs to be clarified.
Read the detailed description
This is a multi-center, retrospective study. Five hospitals in Taiwan and 400 patients Patients treated with grazoprevir/elbasvir during August 2017 to July 2018 are candidates of study subjects. All the required study information will be recorded with detailed chart review.
DDI will be evaluated by HEP Drug Interactions (www.hep-druginteractions.org) assessment of comidications: Category 0: Classification not possible due to lack of information; Category 1: No clinical interaction possible; Category 2: May require dose adjustment/closer monitoring; Category 3: Coadministration not recommended or contraindicated.
The assessment of DDI will be evaluated and recorded according to the suggested categories, the number of patients at risk for a clinically relevant DDI, and the ratio of patients with at least one predicted DDI between medication of grazoprevir/elbasvir will be calculated.
- Conditions
- Drug Interaction Potentiation
- Being tested
- elbasvir/grazoprevir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elbasvir/grazoprevirDrug
Also called Zepatier
Comedications during elbasvir/grazoprevir will be recorded and analyzed for potential drug-drug interaction.
| Study group | Role | What they receive |
|---|---|---|
| Drug interaction of Elbasvir/Grazoprevir | Patients treated with elbasvir/grazoprevir will be enrolled. DDI will be evaluated. Receives: Drug: elbasvir/grazoprevir |
What is being measured
The primary outcome is the main question the study is designed to answer.
the potential drug drug interaction of elbasvir/grazoprevor
the ratio of patients with at least one predicted DDI will be analyzed.
Measured: DDI will be assessed before and through the 12 weeks or 16 weeks of elbasvir/grazoprevir treatment
Secondary outcomes (1)
the comorbid diseases of CHC patients in Taiwan
Comorbid diseases will be recorded and categorized by involved organ systems before elbasvir/grazoprevir treatment.
Measured: Comorbid diseases will be assessed before elbasvir/grazoprevir treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start22 Oct 2018
- Primary completion25 Feb 2019
- Study completion25 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug Interaction PotentiationStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Pin-Nan Cheng, National Cheng-Kung University Hospital
- Investigators
- Pin-Nan Cheng, M.D., Principal investigator, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706222
- Sponsor's protocol ID
- MISP#57751
- Status last verified
- Mar 2019
- First submitted
- 8 Oct 2018
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu CJ, Tseng KC, Lo CC, Tseng IH, Cheng PN. Limited drug-drug interaction of elbasvir/grazoprevir for chronic hepatitis C. J Formos Med Assoc. 2020 May;119(5):933-940. doi: 10.1016/j.jfma.2019.09.011. Epub 2019 Oct 5.
PubMed 31594667
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Real World Analysis of Drug-Drug Interactions of Grazoprevir/Elbasvir in Treatment of Chronic Hepatitis C Patients in Taiwan
- ClinicalTrials.gov ID
- NCT03706222
- Acronym / sponsor ID
- MISP#57751
- Conditions
- Drug Interaction Potentiation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 25 Feb 2019 (actual)
- Study completion
- 25 Feb 2019 (actual)
- First posted
- 15 Oct 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.
Co-morbid diseases often present in a substantial proportion of patients with chronic hepatitis C (CHC) and require drugs to treat and control. Grazoprevir/elbavir is metabolized by cytochrome P-450 enzyme of liver. Drug-drug interactions (DDIs) are important issue before commencing direct acting antiviral agents (DAA) treatment for CHC patients. Few studies from Western countries reported that the percentages of DDIs of grazoprevir/elbasvir are limited.In Asia, real-world analysis of DDIs of grazoprevir/elbasvir is lacking and needs to be clarified.
Detailed description
This is a multi-center, retrospective study. Five hospitals in Taiwan and 400 patients Patients treated with grazoprevir/elbasvir during August 2017 to July 2018 are candidates of study subjects. All the required study information will be recorded with detailed chart review.
DDI will be evaluated by HEP Drug Interactions (www.hep-druginteractions.org) assessment of comidications: Category 0: Classification not possible due to lack of information; Category 1: No clinical interaction possible; Category 2: May require dose adjustment/closer monitoring; Category 3: Coadministration not recommended or contraindicated.
The assessment of DDI will be evaluated and recorded according to the suggested categories, the number of patients at risk for a clinically relevant DDI, and the ratio of patients with at least one predicted DDI between medication of grazoprevir/elbasvir will be calculated.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug interaction of Elbasvir/Grazoprevir | – | Drug: elbasvir/grazoprevirPatients treated with elbasvir/grazoprevir will be enrolled. DDI will be evaluated. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients infected with genotype 1 or 4 hepatitis C virus and treated with elbasvir/grazoprevir during August 2017 to July 2018 in Taiwan.
Key inclusion criteria (1 listed)
- Patients treated with grazoprevir/elbasvir are candidates of study subjects.
Key exclusion criteria (1 listed)
- none
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: ZepatierComedications during elbasvir/grazoprevir will be recorded and analyzed for potential drug-drug interaction. | Drug | Drug interaction of Elbasvir/Grazoprevir |
Primary outcome
the potential drug drug interaction of elbasvir/grazoprevor
Time frame: DDI will be assessed before and through the 12 weeks or 16 weeks of elbasvir/grazoprevir treatment
the ratio of patients with at least one predicted DDI will be analyzed.
1 secondary outcome
the comorbid diseases of CHC patients in Taiwan
Time frame: Comorbid diseases will be assessed before elbasvir/grazoprevir 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 13 Mar 2019.
- Derived from this study: PubMed 31594667Liu CJ, Tseng KC, Lo CC, Tseng IH, Cheng PN. Limited drug-drug interaction of elbasvir/grazoprevir for chronic hepatitis C. J Formos Med Assoc. 2020 May;119(5):933-940. doi: 10.1016/j.jfma.2019.09.011. Epub 2019 Oct 5.
- Individual participant dataSharing planned: No
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.
Pin-Nan Cheng, M.D. principal investigator
National Cheng-Kung University Hospital
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 Drug Interaction Potentiation, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 1 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 13 Mar 2019. 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 Taiwan. 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?
the potential drug drug interaction of elbasvir/grazoprevor (time frame: DDI will be assessed before and through the 12 weeks or 16 weeks of elbasvir/grazoprevir treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03706222, which also lists 1 linked publication.
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 13 Mar 2019.