Chronic Hepatitis CNCT04301882
An Observational Cohort Study of Clinical Outcomes After Antiviral Treatment of Chronic Hepatitis C
An observational study of Chronic Hepatitis C, run by Beijing Ditan Hospital at 1 site in China.
Trial summary
This study is a two-way, non-interventional long-term dynamic follow-up clinical observational cohort study. In the Second Division of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, chronic hepatitis C patients who were treated with interferon combined with ribavirin (PR) antiviral therapy (PR… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- interferon combined with ribavirin (PR) antiviral therapy and direct antiviral drugs (DAAs)
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 1 Sep 2020
- How long will I take part?
- 144 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic hepatitis C treated with interferon combined with ribavirin (PR) antiviral therapy (PR therapy for 6 months or more) and / or direct antiviral drugs (DAAs). All patients with chronic hepatitis C met the diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis C (2015).
Who may be able to join
- Ages 18 to 75;
- Unlimited gender;
- Patients with chronic hepatitis C treated with interferon combined with ribavirin (PR) antiviral therapy (PR therapy for 6 months or more) and / or direct antiviral drugs (DAAs). All patients with chronic hepatitis C met the diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis C (2015)
- No hormones and / or immunosuppressants and other hepatoprotective drugs;
- Sign a written informed consent.
Who cannot join
- Combined with other hepatitis virus (HBV, HDV) infections;
- Immune liver disease;
- HIV infection;
- long-term alcohol and / or other liver damage drugs;
- mental illness;
- Evidence of liver tumor (liver cancer or AFP> 100 ng / ml);
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- Decompensated cirrhosis;
- Those who have serious heart, brain, lung, kidney and other system diseases that cannot participate in long-term follow-up;
- There are hormones and / or immunosuppressants and other hepatoprotective drugs.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Hepatology Division 2, Beijing Ditan Hospital
Beijing, Beijing Municipality, 100015
Yao Xie, Doctor, 8610-84322200 ext. 2489, xieyao00120184@sina.com
Minghui Li, phD, +86 10-84322284, wuhm2000@sina.com
About this study
Official title: An Observational Cohort Study of Clinical Outcomes After Antiviral Treatment of Chronic Hepatitis C Patients
This study is a two-way, non-interventional long-term dynamic follow-up clinical observational cohort study. In the Second Division of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, chronic hepatitis C patients who were treated with interferon combined with ribavirin (PR) antiviral therapy (PR treatment for 6 months or more) and / or direct acting antivirals (DAAs ), and the baseline, antiviral treatment and discontinuation follow-up data of patients before antiviral treatment were collected, and follow-up observations of patients were carried out for every 3-6 months. The clinical data such as clinical biochemistry, HCV RNA and serological indicators (anti-HCV), AFP, and liver imaging (liver ultrasound) were collected during the study period. The virological response and clinical outcomes of chronic hepatitis C antiviral therapy were observed for at least 144 weeks. The incidence of liver cancer and decompensated liver cirrhosis after discontinuation of the drug was the main evaluation index. The aim is to explore long-term virological response and clinical outcomes, and elucidate its influencing factors.
Read the detailed description
This study is a two-way, non-interventional long-term dynamic follow-up clinical observational cohort study. Enrolled in the Second Division of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, via interferon combined with ribavirin (PR) antiviral therapy (PR treatment for 6 months or more) and / or direct acting antivirals (DAAs ) For patients with chronic hepatitis C treated, collect baseline, antiviral treatment and discontinuation follow-up data of patients before antiviral treatment, and follow-up observations of patients enrolled every 3-6 months. Collect clinical data such as clinical biochemistry, HCV RNA and serological indicators (anti-HCV), AFP, and liver imaging (liver ultrasound) during the study period. The virological response and clinical outcomes of chronic hepatitis C antiviral therapy were observed for at least 144 weeks. The incidence of liver cancer and decompensated liver cirrhosis after discontinuation of the drug was the main evaluation index. The aim is to explore long-term virological response and clinical outcomes, and elucidate its influencing factors.
- Conditions
- Chronic Hepatitis C
- Being tested
- interferon combined with ribavirin (PR) antiviral therapy, direct antiviral drugs (DAAs)
- Keywords
- Chronic hepatitis C, Interferon, Ribavirin, Clinical outcome
- 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.
interferon combined with ribavirin (PR) antiviral therapyDrug
Patients with chronic hepatitis C treated with interferon combined with ribavirin (PR) antiviral therapy (PR therapy greater than or equal to 6 months)
direct antiviral drugs (DAAs)Drug
Patients with chronic hepatitis C treated with direct antiviral drugs (DAAs)
| Study group | Role | What they receive |
|---|---|---|
| interferon combined with ribavirin (PR) antiviral therapy | Patients with chronic hepatitis C treated with interferon combined with ribavirin (PR) antiviral therapy (PR therapy greater than or equal to 6 months) Receives: Drug: interferon combined with ribavirin (PR) antiviral therapy | |
| direct antiviral drugs (DAAs) | Patients with chronic hepatitis C treated with direct antiviral drugs (DAAs) Receives: Drug: direct antiviral drugs (DAAs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of liver cancer
Incidence of liver cancer after chronic hepatitis C antiviral treatment
Measured: 144 weeks after withdrawal
Incidence of decompensated cirrhosis
Incidence of decompensated cirrhosis after chronic hepatitis C antiviral treatment
Measured: 144 weeks after withdrawal
Secondary outcomes (1)
Rate of sustained virological response or relapse
Rate of sustained virological response or relapse after antiviral treatment of chronic hepatitis C
Measured: 144 weeks after withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start1 Sep 2019
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Sep 2020 (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.
- 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
- 1,000 participants (estimated)
- Target duration
- 144 Weeks
Sponsor and investigators
- Lead sponsor
- Beijing Ditan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yao Xie, Beijing Ditan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301882
- Sponsor's protocol ID
- DTXY023
- Status last verified
- Mar 2020
- First submitted
- 5 Mar 2020
- Last updated
- 10 Mar 2020
- 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 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Cohort Study of Clinical Outcomes After Antiviral Treatment of Chronic Hepatitis C Patients
- ClinicalTrials.gov ID
- NCT04301882
- Acronym / sponsor ID
- DTXY023
- Conditions
- Chronic Hepatitis C
- Keywords
- Chronic hepatitis C, Interferon, Ribavirin, Clinical outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Beijing Ditan HospitalUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 10 Mar 2020 (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.
This study is a two-way, non-interventional long-term dynamic follow-up clinical observational cohort study. In the Second Division of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, chronic hepatitis C patients who were treated with interferon combined with ribavirin (PR) antiviral therapy (PR treatment for 6 months or more) and / or direct acting antivirals (DAAs ), and the baseline, antiviral treatment and discontinuation follow-up data of patients before antiviral treatment were collected, and follow-up observations of patients were carried out for every 3-6 months. The clinical data such as clinical biochemistry, HCV RNA and serological indicators (anti-HCV), AFP, and liver imaging (liver ultrasound) were collected during the study period. The virological response and clinical outcomes of chronic hepatitis C antiviral therapy were observed for at least 144 weeks. The incidence of liver cancer and decompensated liver cirrhosis after discontinuation of the drug was the main evaluation index. The aim is to explore long-term virological response and clinical outcomes, and elucidate its influencing factors.
Detailed description
This study is a two-way, non-interventional long-term dynamic follow-up clinical observational cohort study. Enrolled in the Second Division of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, via interferon combined with ribavirin (PR) antiviral therapy (PR treatment for 6 months or more) and / or direct acting antivirals (DAAs ) For patients with chronic hepatitis C treated, collect baseline, antiviral treatment and discontinuation follow-up data of patients before antiviral treatment, and follow-up observations of patients enrolled every 3-6 months. Collect clinical data such as clinical biochemistry, HCV RNA and serological indicators (anti-HCV), AFP, and liver imaging (liver ultrasound) during the study period. The virological response and clinical outcomes of chronic hepatitis C antiviral therapy were observed for at least 144 weeks. The incidence of liver cancer and decompensated liver cirrhosis after discontinuation of the drug was the main evaluation index. The aim is to explore long-term virological response and clinical outcomes, and elucidate its influencing factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 144 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interferon combined with ribavirin (PR) antiviral therapy | – | Drug: interferon combined with ribavirin (PR) antiviral therapyPatients with chronic hepatitis C treated with interferon combined with ribavirin (PR) antiviral therapy (PR therapy greater than or equal to 6 months) |
| direct antiviral drugs (DAAs) | – | Drug: direct antiviral drugs (DAAs)Patients with chronic hepatitis C treated with direct antiviral drugs (DAAs) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic hepatitis C treated with interferon combined with ribavirin (PR) antiviral therapy (PR therapy for 6 months or more) and / or direct antiviral drugs (DAAs). All patients with chronic hepatitis C met the diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis C (2015).
Key inclusion criteria (5 listed)
- Ages 18 to 75;
- Unlimited gender;
- Patients with chronic hepatitis C treated with interferon combined with ribavirin (PR) antiviral therapy (PR therapy for 6 months or more) and / or direct antiviral drugs (DAAs). All patients with chronic hepatitis C met the diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis C (2015)
- No hormones and / or immunosuppressants and other hepatoprotective drugs;
- Sign a written informed consent.
Key exclusion criteria (9 listed)
- Combined with other hepatitis virus (HBV, HDV) infections;
- Immune liver disease;
- HIV infection;
- long-term alcohol and / or other liver damage drugs;
- mental illness;
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 |
|---|---|---|
| interferon combined with ribavirin (PR) antiviral therapyPatients with chronic hepatitis C treated with interferon combined with ribavirin (PR) antiviral therapy (PR therapy greater than or equal to 6 months) | Drug | interferon combined with ribavirin (PR) antiviral therapy |
| direct antiviral drugs (DAAs)Patients with chronic hepatitis C treated with direct antiviral drugs (DAAs) | Drug | direct antiviral drugs (DAAs) |
Primary outcome
Incidence of liver cancer
Time frame: 144 weeks after withdrawal
Incidence of liver cancer after chronic hepatitis C antiviral treatment
Incidence of decompensated cirrhosis
Time frame: 144 weeks after withdrawal
Incidence of decompensated cirrhosis after chronic hepatitis C antiviral treatment
1 secondary outcome
Rate of sustained virological response or relapse
Time frame: 144 weeks after withdrawal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
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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.
Department of Hepatology Division 2, Beijing Ditan Hospital
Beijing, China
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 Chronic Hepatitis C, run by Beijing Ditan Hospital at 1 site in China.
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 9 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 10 Mar 2020. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of liver cancer (time frame: 144 weeks after withdrawal). 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 10 Mar 2020.