Hepatitis BHBVNCT03919565
Optimized Treatment of Peginterferon Alfa 2a/2b in Anti-virus Treatment Naive Patients With HBV Related Liver Fibrosis
A study testing Tenofovir Disoproxil Fumarate, Peginterferon Alfa-2a and Peginterferon Alfa-2b in people with Hepatitis B and Liver Fibrosis, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
Compared to nucleoside/nucleotide analogues, peginterferon alfa 2a/2b may has more therapeutic efficacy in hepatitis B surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Hepatitis B, Liver Fibrosis
- What is being tested?
- Tenofovir Disoproxil Fumarate, Peginterferon Alfa-2a and Peginterferon Alfa-2b
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2019to 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Positive hepatitis b surface antigen or hepatitis b virus DNA > 0.5 year;
- Age from 18 to 55 years old;
- Fibrosis lever of F1 to F3 from liver biopsy; if liver biopsy unreachable, fibrosis lever of 7 to 14 kpa from fibroscan;
- Portal vein diameter ≤ 12 mm from liver ultrasound;
- Without treatment of anti-virus treatment ever before.
Who cannot join
- Decompensated cirrhosis, hepatocellular carcinoma or other malignancy;
- Pregnancy or lactation;
- Other active liver diseases；
- 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, 1 recruiting
- Recruiting
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Liang Peng, Doctor, +8613533978874, pzp33@hotmail.com
About this study
Official title: Study on Optimized Treatment of Peginterferon Alfa 2a or 2b in Anti-virus Treatment Naive Patients With Hepatitis b Virus Related Liver Fibrosis
Compared to nucleoside/nucleotide analogues, peginterferon alfa 2a/2b may has more therapeutic efficacy in hepatitis B surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. We design this study to investigate treatment of peginterferon alfa 2a/2b in anti-virus treatment naive patients with HBV related liver fibrosis.
Read the detailed description
Compared to nucleoside/nucleotide analogues, peginterferon alfa 2a/2b may has more therapeutic efficacy in hepatitis B surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. But there still lacks of studies on peginterferon alfa 2a or 2b treatment in patients with HBV related liver fibrosis. We design this study to investigate optimized treatment of peginterferon alfa 2a/2b, comparing to nucleoside/nucleotide analogues, in anti-virus treatment naive patients with HBV related liver fibrosis.
- Conditions
- Hepatitis B, Liver Fibrosis
- Being tested
- Tenofovir Disoproxil Fumarate, Peginterferon Alfa-2a, Peginterferon Alfa-2b
- Keywords
- hepatitis b virus, peginterferon alfa, liver fibrosis
- Medical subject headings
- Hepatitis B, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir Disoproxil FumarateDrug
Also called Viread
Patients would receive oral Tenofovir Disoproxil Fumarate 300mg once per day.
Peginterferon Alfa-2aDrug
Also called Pegasys
Patients would receive subcutaneous injection of Peginterferon Alfa-2a 180 μg once per week.
Peginterferon Alfa-2bDrug
Also called Pegintron
Patients would receive subcutaneous injection of Peginterferon Alfa-2b 80 μg once per week.
| Study group | Role | What they receive |
|---|---|---|
| TDF group | Active comparator | 80 patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from baseline to 144 weeks. Receives: Drug: Tenofovir Disoproxil Fumarate |
| Peginterferon alfa group | Experimental | 40 patients would receive treatment of subcutaneous injection of peginterferon alfa 2a 180 μg or peginterferon alfa 2b 80μg once per week from baseline to 48 weeks. Then they would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from 49 to 144 weeks. Receives: Drug: Peginterferon Alfa-2a; Drug: Peginterferon Alfa-2b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of level of liver fibrosis after anti-virus treatment
Liver biopsy or fibroscan would be accessed to know the change of level of liver fibrosis at 48 and 144 weeks after anti-virus treatment.
Measured: 48 week, 144 week
Secondary outcomes (3)
Ratio of patients with undetectable hepatitis b virus DNA after anti-virus treatment
Hepatitis b virus DNA would be tested to know the ratio of patients with undetectable hepatitis b virus DNA at 6 time points after anti-virus treatment.
Measured: 24 week, 48 week, 72 week, 96 week, 120 week,144 week
Ratio of patients with hepatitis B e antigen seroconversion after anti-virus treatment
Hepatitis b e antigen and hepatitis b e antibody would be tested to know the ratio of patients with negative hepatitis B e antigen and positive hepatitis B e antibody at 6 time points after anti-virus treatment.
Measured: 24 week, 48 week, 72 week, 96 week, 120 week,144 week
Ratio of patients with hepatitis b surface antigen seroconversion after anti-virus treatment
Hepatitis b surface antigen and hepatitis b surface antibody would be tested to know the ratio of patients with negative hepatitis B surface antigen and positive hepatitis B surface antibody at 6 time points after anti-virus treatment.
Measured: 24 week, 48 week, 72 week, 96 week, 120 week,144 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start1 Feb 2019
- Primary completion31 Oct 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 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
- 120 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
- NCT03919565
- Sponsor's protocol ID
- PL4
- Acronym
- HBV
- Status last verified
- Apr 2019
- First submitted
- 16 Apr 2019
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Optimized Treatment of Peginterferon Alfa 2a or 2b in Anti-virus Treatment Naive Patients With Hepatitis b Virus Related Liver Fibrosis
- ClinicalTrials.gov ID
- NCT03919565
- Acronym / sponsor ID
- HBV / PL4
- Conditions
- Hepatitis B, Liver Fibrosis
- Keywords
- hepatitis b virus, peginterferon alfa, liver fibrosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 18 Apr 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.
Compared to nucleoside/nucleotide analogues, peginterferon alfa 2a/2b may has more therapeutic efficacy in hepatitis B surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. We design this study to investigate treatment of peginterferon alfa 2a/2b in anti-virus treatment naive patients with HBV related liver fibrosis.
Detailed description
Compared to nucleoside/nucleotide analogues, peginterferon alfa 2a/2b may has more therapeutic efficacy in hepatitis B surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. But there still lacks of studies on peginterferon alfa 2a or 2b treatment in patients with HBV related liver fibrosis. We design this study to investigate optimized treatment of peginterferon alfa 2a/2b, comparing to nucleoside/nucleotide analogues, in anti-virus treatment naive patients with HBV related liver fibrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TDF group | Active comparator | Drug: Tenofovir Disoproxil Fumarate80 patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from baseline to 144 weeks. |
| Peginterferon alfa group | Experimental | Drug: Peginterferon Alfa-2a, Drug: Peginterferon Alfa-2b40 patients would receive treatment of subcutaneous injection of peginterferon alfa 2a 180 μg or peginterferon alfa 2b 80μg once per week from baseline to 48 weeks. Then they would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from 49 to 144 weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Positive hepatitis b surface antigen or hepatitis b virus DNA > 0.5 year;
- Age from 18 to 55 years old;
- Fibrosis lever of F1 to F3 from liver biopsy; if liver biopsy unreachable, fibrosis lever of 7 to 14 kpa from fibroscan;
- Portal vein diameter ≤ 12 mm from liver ultrasound;
- Without treatment of anti-virus treatment ever before.
Key exclusion criteria (7 listed)
- Decompensated cirrhosis, hepatocellular carcinoma or other malignancy;
- Pregnancy or lactation;
- Other active liver diseases；
- 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 |
|---|---|---|
| Tenofovir Disoproxil FumarateAlso: VireadPatients would receive oral Tenofovir Disoproxil Fumarate 300mg once per day. | Drug | TDF group |
| Peginterferon Alfa-2aAlso: PegasysPatients would receive subcutaneous injection of Peginterferon Alfa-2a 180 μg once per week. | Drug | Peginterferon alfa group |
| Peginterferon Alfa-2bAlso: PegintronPatients would receive subcutaneous injection of Peginterferon Alfa-2b 80 μg once per week. | Drug | Peginterferon alfa group |
Primary outcome
Change of level of liver fibrosis after anti-virus treatment
Time frame: 48 week, 144 week
Liver biopsy or fibroscan would be accessed to know the change of level of liver fibrosis at 48 and 144 weeks after anti-virus treatment.
3 secondary outcomes
Ratio of patients with undetectable hepatitis b virus DNA after anti-virus treatment
Time frame: 24 week, 48 week, 72 week, 96 week, 120 week,144 week
Ratio of patients with hepatitis B e antigen seroconversion after anti-virus treatment
Time frame: 24 week, 48 week, 72 week, 96 week, 120 week,144 week
Ratio of patients with hepatitis b surface antigen seroconversion after anti-virus treatment
Time frame: 24 week, 48 week, 72 week, 96 week, 120 week,144 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 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.
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 Tenofovir Disoproxil Fumarate, Peginterferon Alfa-2a and Peginterferon Alfa-2b in people with Hepatitis B and Liver Fibrosis, 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 5 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 19 Apr 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 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?
Change of level of liver fibrosis after anti-virus treatment (time frame: 48 week, 144 week). 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 19 Apr 2019.