Chronic Hepatitis bNCT03733652
Optimal Treatment for Poor Efficacy of Entecavir in Chronic Hepatitis B Patients
A study testing Interferon Alfa 2a in people with Chronic Hepatitis b and Efficacy, Self, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
There are chronic hepatitis B patients with poor antiviral efficacy of entecavir in clinical practice. Tenofovir or interferon alfa is the optimal choice right now. The aim of this study is to investigate the therapeutic effect of using tenofovir of interferon alfa in these patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis b, Efficacy, Self
- What is being tested?
- Interferon Alfa 2a
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2018to 31 Dec 2021
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hepatitis b virus DNA or HBsAg positive for over half a year;
- Age from 18 to 65;
- With poor efficacy of entecavir: Hepatitis b virus DNA is still positive at 24 weeks, and decrease > 2 lg from baseline .
- Not be treated with interferon alfa ever before.
Who cannot join
- Other active liver diseases;
- Cirrhosis, hepatocellular carcinoma or other malignancy;
- Pregnancy or lactation;
- Human immunodeficiency virus infection or congenital immune deficiency diseases;
- Severe diabetes, autoimmune diseases;
- Other important organ dysfunctions;
- Patients can not follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
About this study
Official title: Study on the Optimal Treatment for Poor Efficacy of Entecavir in Chronic Hepatitis B Patients
There are chronic hepatitis B patients with poor antiviral efficacy of entecavir in clinical practice. Tenofovir or interferon alfa is the optimal choice right now. The aim of this study is to investigate the therapeutic effect of using tenofovir of interferon alfa in these patients.
Read the detailed description
There are chronic hepatitis B patients with poor antiviral efficacy of entecavir in clinical practice. Poor efficacy is defined as hepatitis b virus DNA is still positive and decreases > 2 lg from baseline. Sequential therapy by using tenofovir or interferon alfa is the optimal choice right now. 100 patients with poor antiviral efficacy of entecavir will be recruited in this study. They are randomly divided into tenofovir group or interferon alfa group. The aim of this study is to investigate the therapeutic effect of using tenofovir of interferon alfa in these patients.
- Conditions
- Chronic Hepatitis b, Efficacy, Self
- Being tested
- Interferon Alfa 2a
- Keywords
- Chronic Hepatitis B, entecavir
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon Alfa 2aDrug
Also called Pegasys
Patents are treated with interferon alfa 2a 180μg hypodermic injection once per week for 48 weeks. Then, interferon alfa 2a will be stopped if there is HBsAg clearance. Else, oral tenofovir 300mg once per day will be used if HBsAg is positive.
| Study group | Role | What they receive |
|---|---|---|
| Tenofovir | No intervention | Patents are treated with oral tenofovir 300mg once per day for 48 weeks. Then, tenofovir will be stopped if there is HBsAg clearance. Else, oral tenofovir 300mg once per day will be continued if HBsAg is positive. |
| Interferon alfa | Active comparator | Patents are treated with interferon alfa 2a 180μg hypodermic injection once per week for 48 weeks. Then, interferon alfa 2a will be stopped if there is HBsAg clearance. Else, oral tenofovir 300mg once per day will be used if HBsAg is positive. Receives: Drug: Interferon Alfa 2a |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBsAg decrease after 48 weeks treatment
The patients recruited will be treated with tenofovir or interferon alfa. After 48 weeks treatment, level of HBsAg will be tested again. The investigators want to know the rate of patients with HBsAg level that decreases more than 2 lg from baseline.
Measured: 48 weeks
Secondary outcomes (2)
HBsAg clearance after 48 weeks treatment
The patients recruited would be treated with tenofovir or interferon alfa. After 48 weeks treatment, level of HBsAg will be tested again. The investigators want to know the rate of patients with HBsAg clearance which is lower than 0.05 IU/ml.
Measured: 48 weeks
Undetectable hepatitis b virus DNA after 48 weeks treatment
The patients recruited would be treated with tenofovir or interferon alfa. After 48 weeks treatment, level of hepatitis b virus DNA will be tested again. The investigators want to know the rate of patients with undetectable hepatitis b virus DNA which is lower than 20 IU/ml.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start15 Nov 2018 (estimated)
- Primary completion30 Sep 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis bStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang Peng, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Liang Peng, Doctor, Principal investigator, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733652
- Sponsor's protocol ID
- PL3
- Status last verified
- Nov 2018
- First submitted
- 6 Nov 2018
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Optimal Treatment for Poor Efficacy of Entecavir in Chronic Hepatitis B Patients
- ClinicalTrials.gov ID
- NCT03733652
- Acronym / sponsor ID
- PL3
- Conditions
- Chronic Hepatitis b, Efficacy, Self
- Keywords
- Chronic Hepatitis B, entecavir
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 15 Nov 2018 (estimated)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 7 Nov 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.
There are chronic hepatitis B patients with poor antiviral efficacy of entecavir in clinical practice. Tenofovir or interferon alfa is the optimal choice right now. The aim of this study is to investigate the therapeutic effect of using tenofovir of interferon alfa in these patients.
Detailed description
There are chronic hepatitis B patients with poor antiviral efficacy of entecavir in clinical practice. Poor efficacy is defined as hepatitis b virus DNA is still positive and decreases > 2 lg from baseline. Sequential therapy by using tenofovir or interferon alfa is the optimal choice right now. 100 patients with poor antiviral efficacy of entecavir will be recruited in this study. They are randomly divided into tenofovir group or interferon alfa group. The aim of this study is to investigate the therapeutic effect of using tenofovir of interferon alfa in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tenofovir | No intervention | –Patents are treated with oral tenofovir 300mg once per day for 48 weeks. Then, tenofovir will be stopped if there is HBsAg clearance. Else, oral tenofovir 300mg once per day will be continued if HBsAg is positive. |
| Interferon alfa | Active comparator | Drug: Interferon Alfa 2aPatents are treated with interferon alfa 2a 180μg hypodermic injection once per week for 48 weeks. Then, interferon alfa 2a will be stopped if there is HBsAg clearance. Else, oral tenofovir 300mg once per day will be used if HBsAg is positive. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hepatitis b virus DNA or HBsAg positive for over half a year;
- Age from 18 to 65;
- With poor efficacy of entecavir: Hepatitis b virus DNA is still positive at 24 weeks, and decrease > 2 lg from baseline .
- Not be treated with interferon alfa ever before.
Key exclusion criteria (7 listed)
- Other active liver diseases;
- Cirrhosis, hepatocellular carcinoma or other malignancy;
- Pregnancy or lactation;
- Human immunodeficiency virus infection or congenital immune deficiency diseases;
- Severe diabetes, autoimmune diseases;
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 Alfa 2aAlso: PegasysPatents are treated with interferon alfa 2a 180μg hypodermic injection once per week for 48 weeks. Then, interferon alfa 2a will be stopped if there is HBsAg clearance. Else, oral tenofovir 300mg once per day will be used if HBsAg is positive. | Drug | Interferon alfa |
Primary outcome
HBsAg decrease after 48 weeks treatment
Time frame: 48 weeks
The patients recruited will be treated with tenofovir or interferon alfa. After 48 weeks treatment, level of HBsAg will be tested again. The investigators want to know the rate of patients with HBsAg level that decreases more than 2 lg from baseline.
2 secondary outcomes
HBsAg clearance after 48 weeks treatment
Time frame: 48 weeks
Undetectable hepatitis b virus DNA after 48 weeks treatment
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2018.
- Individual participant dataSharing planned: Undecided
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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.
Liang Peng, Doctor principal investigator
Third Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interferon Alfa 2a in people with Chronic Hepatitis b and Efficacy, Self, run by Third Affiliated Hospital, Sun Yat-Sen University 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 4 inclusion and 7 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 23 Nov 2018. 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?
Contact Wenxiong Xu, Doctor (+8613760783281, xwx1983@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBsAg decrease after 48 weeks treatment (time frame: 48 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 23 Nov 2018.