Hepatitis BNCT03957629
Optimized Treatment of Peginterferon Alfa 2a in Treatment Experienced Patients With HBV Related Liver Fibrosis
A study testing Tenofovir Disoproxil Fumarate and PEG-Interferon alfa 2a 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 TDF, peginterferon alfa 2a 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 and PEG-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
- 186 participants
- Where
- 1 siteChina
- Study dates
- 6 Nov 2019to 30 Jul 2023
- 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;
- Receiving treatment of nucleoside/nucleotide analogues at least one year before recruited;
- Age from 18 to 55 years old;
- Normal liver function(ALT<ULN,AST<ULN and TBil<ULN).
- Undetectable hepatitis b virus DNA or less than 100IU/ml.
- LSM between 6 and 12 kpa measured by fibroscan;
- Liver ultrasound: normal or echo thickening, and portal vein diameter ≤ 12mm.
Who cannot join
- Decompensated cirrhosis, hepatocellular carcinoma or other malignancy;
- Pregnancy, lactation or female has plan of pregnancy within 18 months;
- Accompanied with other active liver diseases(HAV, HCV, HDV, HEV, autoimmune liver disease, drug-induced liver injury, alcoholic liver disease, genetic metabolic liver disease, etc.)；
- Accompanied with human immunodeficiency virus infection or congenital immune deficiency diseases;
- Accompanied with severe diabetes, autoimmune diseases etc. and other important organ dysfunctions;
- Patients who fail to comply with this research arrangement and sign an informed consent form
- Patients can not follow-up;
- Investigator considering inappropriate.
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: An Open, Multi-center Clinical Study of Combination Therapy With Tenofovir Disoproxil Fumarate and Peginterferon Alpha 2a in Nucleos(t)Ide Analogs Experienced Patients With HBV Related Hepatic Fibrosis.
Compared to TDF, peginterferon alfa 2a 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 compare the effectiveness and safety between the combination therapy of TDF and peg-IFN with TDF alone in NAs experienced patients with HBV related liver fibrosis. Especially the improvement of liver fibrosis and the occurrence of long-term end-stage liver disease such as cirrhosis, liver cancer, etc.
Read the detailed description
Compared to TDF, peginterferon alfa 2a 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 compare the effectiveness and safety between the combination therapy of TDF and peg-IFN with TDF alone in NAs experienced patients with HBV related liver fibrosis. Especially the improvement of liver fibrosis and the occurrence of long-term end-stage liver disease such as cirrhosis, liver cancer, etc.
Main purpose: Comparing the improvement rate of liver fibrosis. Secondary purpose: Comparing the incidence of adverse events. Comparing the incidence of cirrhosis, hepatocellular carcinoma, and liver failure.
Comparing the rates of HBsAg and HBeAg serological conversion.
- Conditions
- Hepatitis B, Liver Fibrosis
- Being tested
- Tenofovir Disoproxil Fumarate, PEG-Interferon alfa 2a
- Keywords
- hepatitis b virus, liver fibrosis, peg interferon alfa-2a, tenofovir disoproxil fumarate
- 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, Beixin
Oral medication of Tenofovir Disoproxil Fumarate 300mg once per day.
PEG-Interferon alfa 2aDrug
Also called Pegasys
Subcutaneous injection of Peginterferon Alfa-2a 180 μg once per week.
| Study group | Role | What they receive |
|---|---|---|
| TDF group | Active comparator | 93 patients would receive treatment of oral medication of tenofovir disoproxil fumarate (TDF) 300mg once per day from baseline to 48 weeks. Then they would receive oral medication of TDF 300 mg once per day from 49 to 96 weeks. Receives: Drug: Tenofovir Disoproxil Fumarate |
| Combination group | Active comparator | 93 patients would receive treatment of subcutaneous injection of peginterferon alfa 2a 180 μg once per week and meanwhile oral medication of tenofovir disoproxil fumarate (TDF) 300 mg once per day from baseline to 48 weeks. Then they would receive oral medication of TDF 300 mg once per day from 49 to 96 weeks. Receives: Drug: Tenofovir Disoproxil Fumarate; Drug: PEG-Interferon alfa 2a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of regression of fibrosis
Regression of fibrosis was defined as liver stiffness measured by transient elastography changed from 9~12kpa to 6~9kpa or below, and from 6~9kpa to less than 6kpa. After treatment, the proportion of patients with regression of fibrosis in the two groups was the ratio of regression of fibrosis, separately.
Measured: 48 weeks; 96 weeks
Secondary outcomes (3)
Ratio of loss of hepatitis b e antigen or/and seroconversion
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 4 time points after anti-virus treatment.
Measured: 24 week, 48 week, 72 week, 96 week
Ratio of loss of hepatitis b s antigen or/and seroconversion
Hepatitis b s antigen and hepatitis b s antibody would be tested to know the ratio of patients with negative hepatitis B s antigen and positive hepatitis B s antibody at 4 time points after anti-virus treatment.
Measured: 24 week, 48 week, 72 week, 96 week
Logarithmic mean of HBsAg decline
Hepatitis b s antigen would be tested to know the decline of patients with positive hepatitis B s antigen at 4 time points after anti-virus treatment.
Measured: 24 week, 48 week, 72 week, 96 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start6 Nov 2019
- Primary completion30 Jul 2021 (estimated)
- Study completion30 Jul 2023 (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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 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
- Peng, ph.D., Study director, Third Affiliated Hospital, Sun Yat-Sen UniversityXu, ph.D., Study director, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957629
- Sponsor's protocol ID
- PL7
- Status last verified
- Jan 2020
- First submitted
- 19 May 2019
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multi-center Clinical Study of Combination Therapy With Tenofovir Disoproxil Fumarate and Peginterferon Alpha 2a in Nucleos(t)Ide Analogs Experienced Patients With HBV Related Hepatic Fibrosis.
- ClinicalTrials.gov ID
- NCT03957629
- Acronym / sponsor ID
- PL7
- Conditions
- Hepatitis B, Liver Fibrosis
- Keywords
- hepatitis b virus, liver fibrosis, peg interferon alfa-2a, tenofovir disoproxil fumarate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 6 Nov 2019 (actual)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 21 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.
Compared to TDF, peginterferon alfa 2a 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 compare the effectiveness and safety between the combination therapy of TDF and peg-IFN with TDF alone in NAs experienced patients with HBV related liver fibrosis. Especially the improvement of liver fibrosis and the occurrence of long-term end-stage liver disease such as cirrhosis, liver cancer, etc.
Detailed description
Compared to TDF, peginterferon alfa 2a 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 compare the effectiveness and safety between the combination therapy of TDF and peg-IFN with TDF alone in NAs experienced patients with HBV related liver fibrosis. Especially the improvement of liver fibrosis and the occurrence of long-term end-stage liver disease such as cirrhosis, liver cancer, etc.
Main purpose: Comparing the improvement rate of liver fibrosis. Secondary purpose: Comparing the incidence of adverse events. Comparing the incidence of cirrhosis, hepatocellular carcinoma, and liver failure.
Comparing the rates of HBsAg and HBeAg serological conversion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TDF group | Active comparator | Drug: Tenofovir Disoproxil Fumarate93 patients would receive treatment of oral medication of tenofovir disoproxil fumarate (TDF) 300mg once per day from baseline to 48 weeks. Then they would receive oral medication of TDF 300 mg once per day from 49 to 96 weeks. |
| Combination group | Active comparator | Drug: Tenofovir Disoproxil Fumarate, Drug: PEG-Interferon alfa 2a93 patients would receive treatment of subcutaneous injection of peginterferon alfa 2a 180 μg once per week and meanwhile oral medication of tenofovir disoproxil fumarate (TDF) 300 mg once per day from baseline to 48 weeks. Then they would receive oral medication of TDF 300 mg once per day from 49 to 96 weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Positive hepatitis b surface antigen or hepatitis b virus DNA > 0.5 year;
- Receiving treatment of nucleoside/nucleotide analogues at least one year before recruited;
- Age from 18 to 55 years old;
- Normal liver function(ALT<ULN,AST<ULN and TBil<ULN).
- Undetectable hepatitis b virus DNA or less than 100IU/ml.
Key exclusion criteria (8 listed)
- Decompensated cirrhosis, hepatocellular carcinoma or other malignancy;
- Pregnancy, lactation or female has plan of pregnancy within 18 months;
- Accompanied with other active liver diseases(HAV, HCV, HDV, HEV, autoimmune liver disease, drug-induced liver injury, alcoholic liver disease, genetic metabolic liver disease, etc.)；
- Accompanied with human immunodeficiency virus infection or congenital immune deficiency diseases;
- Accompanied with severe diabetes, autoimmune diseases etc. and other important organ dysfunctions;
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: Viread, BeixinOral medication of Tenofovir Disoproxil Fumarate 300mg once per day. | Drug | Combination group, TDF group |
| PEG-Interferon alfa 2aAlso: PegasysSubcutaneous injection of Peginterferon Alfa-2a 180 μg once per week. | Drug | Combination group |
Primary outcome
Ratio of regression of fibrosis
Time frame: 48 weeks; 96 weeks
Regression of fibrosis was defined as liver stiffness measured by transient elastography changed from 9~12kpa to 6~9kpa or below, and from 6~9kpa to less than 6kpa. After treatment, the proportion of patients with regression of fibrosis in the two groups was the ratio of regression of fibrosis, separately.
3 secondary outcomes
Ratio of loss of hepatitis b e antigen or/and seroconversion
Time frame: 24 week, 48 week, 72 week, 96 week
Ratio of loss of hepatitis b s antigen or/and seroconversion
Time frame: 24 week, 48 week, 72 week, 96 week
Logarithmic mean of HBsAg decline
Time frame: 24 week, 48 week, 72 week, 96 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Peng, ph.D. study director
Third Affiliated Hospital, Sun Yat-Sen University
Xu, ph.D. study director
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 and PEG-Interferon alfa 2a 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 7 inclusion and 8 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 22 Jan 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?
Contact Shu Zhu, Master (+8615626477267, zhush8@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of regression of fibrosis (time frame: 48 weeks; 96 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 22 Jan 2020.