Chronic Hepatitis cNCT03941821
Glecaprevir/Pibrentasvir Real-world Study in China
An observational study of Chronic Hepatitis c, run by Tongji Hospital.
Trial summary
To evaluate the efficacy, adverse effect, short - and long-term outcomes of Glecaprevir/Pibrentasvir for the treatment of chronic hepatitis C (non-cirrhotic or compensatory cirrhosis)in China through a real-world study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis c
- What is being tested?
- Glecaprevir/Pibrentasvir
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2019to 30 Jun 2022
- 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: Patients with chronic hepatitis C who will received Glecaprevir/Pibrentasvir treatment and meet the inclusion and exclusion criteria above
Who may be able to join
- >18 years old
- Meet the standard of Glecaprevir/Pibrentasvir treatment
Who cannot join
- Patients have contraindications to Glecaprevir/Pibrentasvir
- Pregnancy or lactation
- Malignancy
- Decompensatory cirrhosis
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Efficacy, Safety and Long-term Prognosis of Glecaprevir/Pibrentasvir in the Treatment of Chronic Hepatitis C Patients in China--A Real-world Study
To evaluate the efficacy, adverse effect, short - and long-term outcomes of Glecaprevir/Pibrentasvir for the treatment of chronic hepatitis C (non-cirrhotic or compensatory cirrhosis)in China through a real-world study
Read the detailed description
This study is a multi-center, prospective, real-world study, aiming to investigate the use of Glecaprevir/Pibrentasvir in routine clinical management of chronic hepatitis C patients and evaluate its effectiveness and safety across a heterogeneous population in China.Approximately 800 patients will take part in this study, 20 sites will be included which distribute in China's major cities, thus each site will enroll 40 patients.
- Conditions
- Chronic Hepatitis c
- Being tested
- Glecaprevir/Pibrentasvir
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glecaprevir/PibrentasvirDrug
Also called Mavyret
Chronic hepatitis C patients will be given Glecaprevir/Pibrentasvir treatment
| Study group | Role | What they receive |
|---|---|---|
| G/P treatment | Chronic hepatitis C patients who will recieve Glecaprevir/Pibrentasvir treatment Receives: Drug: Glecaprevir/Pibrentasvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
SVR 12
The effectiveness of Glecaprevir/Pibrentasvir treatments and SVR rate 12 weeks after Glecaprevir/Pibrentasvir treatments
Measured: 12 weeks after Glecaprevir/Pibrentasvir treatments
progression of Chronic liver disease
Incidence of liver disease progression (such as cirrhosis, decompensation of liver function, liver cancer, liver transplantation, or liver related death)
Measured: 5 years after Glecaprevir/Pibrentasvir treatments
Secondary outcomes (2)
long term outcome
Assess the duration of the virologic response (5 years) in CHC patients with daas-based regimens who have achieved a sustained virologic response (svr12/24) at 12 or 24 weeks after the end of treatment and analyze the factors influencing the recurrence of HCV
Measured: 5 years
HRQOL
To evaluate the impact of DAAs treatment on health-related quality of life (HRQOL) and health status of CHC patients
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start30 Jun 2019 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis cStudies of the same condition, open and under way.
- More trials run by Tongji 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qin Ning, PHD,MD, Study chair, Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College HUST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941821
- Sponsor's protocol ID
- G/P RWS China
- Status last verified
- May 2019
- First submitted
- 6 May 2019
- Last updated
- 8 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy, Safety and Long-term Prognosis of Glecaprevir/Pibrentasvir in the Treatment of Chronic Hepatitis C Patients in China--A Real-world Study
- ClinicalTrials.gov ID
- NCT03941821
- Acronym / sponsor ID
- G/P RWS China
- Conditions
- Chronic Hepatitis c
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 30 Jun 2019 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 8 May 2019 (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.
To evaluate the efficacy, adverse effect, short - and long-term outcomes of Glecaprevir/Pibrentasvir for the treatment of chronic hepatitis C (non-cirrhotic or compensatory cirrhosis)in China through a real-world study
Detailed description
This study is a multi-center, prospective, real-world study, aiming to investigate the use of Glecaprevir/Pibrentasvir in routine clinical management of chronic hepatitis C patients and evaluate its effectiveness and safety across a heterogeneous population in China.Approximately 800 patients will take part in this study, 20 sites will be included which distribute in China's major cities, thus each site will enroll 40 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| G/P treatment | – | Drug: Glecaprevir/PibrentasvirChronic hepatitis C patients who will recieve Glecaprevir/Pibrentasvir treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic hepatitis C who will received Glecaprevir/Pibrentasvir treatment and meet the inclusion and exclusion criteria above
Key inclusion criteria (2 listed)
- >18 years old
- Meet the standard of Glecaprevir/Pibrentasvir treatment
Key exclusion criteria (4 listed)
- Patients have contraindications to Glecaprevir/Pibrentasvir
- Pregnancy or lactation
- Malignancy
- Decompensatory cirrhosis
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 |
|---|---|---|
| Glecaprevir/PibrentasvirAlso: MavyretChronic hepatitis C patients will be given Glecaprevir/Pibrentasvir treatment | Drug | G/P treatment |
Primary outcome
SVR 12
Time frame: 12 weeks after Glecaprevir/Pibrentasvir treatments
The effectiveness of Glecaprevir/Pibrentasvir treatments and SVR rate 12 weeks after Glecaprevir/Pibrentasvir treatments
progression of Chronic liver disease
Time frame: 5 years after Glecaprevir/Pibrentasvir treatments
Incidence of liver disease progression (such as cirrhosis, decompensation of liver function, liver cancer, liver transplantation, or liver related death)
2 secondary outcomes
long term outcome
Time frame: 5 years
HRQOL
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2019.
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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.
Qin Ning, PHD,MD study chair
Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College HUST
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis c, run by Tongji Hospital.
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 2 inclusion and 4 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 8 May 2019. 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 Ning Qin, PHD,MD (+8602783662391, qning@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SVR 12 (time frame: 12 weeks after Glecaprevir/Pibrentasvir treatments). The study lists 2 primary outcomes in all. 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 8 May 2019.