Chronic Hepatitis BPhase 4NCT02474316
Combined Therapy With Peginterferon Alfa-2a With NA in NA-treated HBeAg Positive Patients
A Phase 4 study testing Peginterferon alfa-2a and nucleos(t)ide analgoue in people with Chronic Hepatitis B, run by Ruijin Hospital at 3 sites in China.
Trial summary
This is a prospective, randomized, multicenter, open-label study. After more than 24 weeks NA treatment, HBeAg positive CHB patients who achieved HBV DNA<1000copies/ml but HBeAb negative, will be randomized (1:1) into 2 study arms as follows: Arm A: Peginterferon alfa-2a 180μg /wk plus NA 1 piece qd for 48 weeks Arm… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Peginterferon alfa-2a and nucleos(t)ide analgoue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 366 participants
- Where
- 3 sitesChina
- Study dates
- Aug 2014to Dec 2017
- Phase
- Phase 4
- 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
- Male and female patients with age ≥18 and ≤65 years;
- There should be evidences that HBsAg and HBeAg have been positive for more than 6 months with HBsAb and HBeAb negative before treated with Entecavir;
- Treated with NA for more than 24 weeks and achieve HBV DNA<1000copies/ml with HBeAb negative;
- Women without ongoing pregnancy or breast feeding and willing to take an effective contraceptive measure during the treatment
- Agree to participate in the study and sign the patient informed consent.
Who cannot join
- Co-infection with active hepatitisA, hepatitisC, hepatitisD and/or human immunodeficiency virus (HIV)
- AFP>50ng/ml and/or evidence of hepatocellular carcinoma
- Evidence of decompensated liver disease (Child-Pugh scores >5). Child-Pugh >5 means that, if one of the following 6 conditions is met, the patient has to be excluded:
- Serum albumin <35 g/L;
- Prothrombine time prolonged≥ 4 seconds or PTA < 60%;
- Serum bilirubin > 34 µmol/L;
Show all 25Show fewer
- History of encephalopathy;
- Ascites
- History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures, thalassemia)
- Pregnant or breast-feeding Women
- ANC<1.5x 10^9/L or PLT<90x 10^9/L
- Consuming alcohol in excess of 20g/day for women and 30g/day for men within 6 months prior to enrollment
- History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as major depression or psychosis that treated with antidepressant medication or a major tranquilizer at therapeutic doses respectively at any time prior to 3 months or any history of the following: a suicidal attempt hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease
- History of immunologically mediated disease, (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, rheumatoid arthritis etc.)
- History of esophageal varices bleeding or other evidence of esophageal varices bleeding or other symptoms consistent with decompensated liver disease
- History of chronic pulmonary disease associated with functional limitation
- History of severe cardiac disease (e.g., NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases)
- Hemodialysis patients or patients with renal insufficiency
- History of a severe seizure disorder or current anticonvulsant use
- Major organ transplantation or other evidence of severe illness, malignancy, or any other conditions, which would make the patient, in the opinion of the investigator, unsuitable for the study
- History of thyroid disease poorly controlled on prescribed medications
- Evidence of severe retinopathy or clinically relevant ophthalmologic disorder
- History of other severe disease or evidence of other severe disease or any other illness or conditions that the investigator believe that patients are not suitable to join in the study
- Immunomodulatory treatment (including interferon) or LDT within 1 year prior to the first dose of treatment
- Patients included in another trial or having been given investigational drugs within 12 weeks prior to screening
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
The Third People's Hospital of Guilin
Guilin
Shuquan Chen, doctor
- Recruiting
Ruijin Hospital
Shanghai
Qing Xie, doctor
Wei Cai, doctor
- Recruiting
Shanghai Public Health Clinical Center
Shanghai
Liang Chen, doctor
About this study
Official title: A Prospective, Randomized, Multicenter, Open-label Study Evaluating HBeAg Seroconversion in HBeAg Positive CHB Patients on Treatment With NA Switched to Combined Therapy With Peginterferon Alfa-2a and NA for 48 Weeks
This is a prospective, randomized, multicenter, open-label study. After more than 24 weeks NA treatment, HBeAg positive CHB patients who achieved HBV DNA<1000copies/ml but HBeAb negative, will be randomized (1:1) into 2 study arms as follows:
Arm A: Peginterferon alfa-2a 180μg /wk plus NA 1 piece qd for 48 weeks Arm B: Entecavir 0.5mg qd for 48 weeks
Read the detailed description
This is a prospective, randomized, multicenter, open-label study. After more than 24 weeks NA treatment, HBeAg positive CHB patients who achieved HBV DNA<1000copies/ml but HBeAb negative, will be randomized (1:1) into 2 study arms as follows:
Arm A: Peginterferon alfa-2a 180μg /wk plus NA 1piece qd for 48 weeks Arm B:NA 1 piece qd for 48 weeks
The primary endpoint: HBeAg seroconversion at week 48
- Conditions
- Chronic Hepatitis B
- Being tested
- Peginterferon alfa-2a, nucleos(t)ide analgoue
- 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.
Peginterferon alfa-2aDrug
Also called Pegasys
Peginterferon alfa-2a 180ug/wk s.c for 48 weeks
nucleos(t)ide analgoueDrug
nucleos(t)ide analgoue (NA) 1 piece p.o for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| PegINF plus nucleos(i)de analgoue | Experimental | Peginterferon alfa-2a 180μg /wk plus nucleos(t)ide analgoue (NA) 1 piece qd for 48 weeks Receives: Drug: Peginterferon alfa-2a; Drug: nucleos(t)ide analgoue |
| nucleos(t)ide analgoue | Active comparator | nucleos(t)ide analgoue (NA) 1 piece qd for 48 weeks Receives: Drug: nucleos(t)ide analgoue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who achieve HBeAg seroconversion
To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve the HBeAg seroconversion in HBeAg positive CHB patients on treatment with Entecavir and with HBV DNA <1000copies/ml which will be measured by the number of participants who achieve HBeAg seroconversion
Measured: at week 48
Secondary outcomes (12)
Number of participants who achieve HBeAg loss
To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve HBeAg seroconversion which will be measured by number of participants who achieve HBeAg loss
Measured: at week 48
Number of participants who achieve HBsAg loss
To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve HBsAg loss which will be measured by number of participants who achieve HBsAg loss
Measured: at week 48
Number of participants who achieve HBsAg seroconversion
To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve HBsAg seroconversion which will be measured by number of participants who achieve HBsAg seroconversion
Measured: at week 48
HBsAg decline from baseline
To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve HBsAg decline from baseline
Measured: at week 48
Percentage of participants who achieve HBsAg <1000IU/mL
To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve the percentage of participants who achieve HBsAg<1000IU/mL
Measured: at week 48
Percentage of of participants who achieve HBsAg <100IU/mL
To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve the percentage of of participants who achieve HBsAg<100IU/mL
Measured: at week 48
Number of participants who achieve combined response I (defined as HBeAg seroconversion and HBV DNA<100000copies/mL)
To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve the combined response I which will be measured by number of participants who achieve combined response I
Measured: at week 48
Number of participants who achieve combined response II (defined as HBeAg seroconversion and HBV DNA<1000copies/mL)
To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve the combined response II which will be measured by number of participants who achieve combined response II
Measured: at week 48
Number of participants who achieve dural response I (defined as HBeAg seroconversion and HBsAg<1000IU/mL)
To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve the dural response I which will be measured by number of participants who achieve dural response I
Measured: at week 48
Number of participants who achieve dural response II (defined as HBeAg seroconversion and HBsAg<100IU/mL)
To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve the dural response II which will be measured by number of participants who achieve dural response II
Measured: at week 48
Number of Participants with AE
Number of participants with adverse events as a measure of safety and tolerability
Measured: at week 48
Number of Participants with SAE
Number of participants with SAEs as a measure of safety and tolerability
Measured: at week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2015 (estimated)
- Study startAug 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by Ruijin 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 366 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing XIe, Ruijin Hospital
- Investigators
- Qing Xie, Study chair, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474316
- Sponsor's protocol ID
- HOPE
- Status last verified
- Jun 2015
- First submitted
- 25 Mar 2015
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lai CL, Ratziu V, Yuen MF, Poynard T. Viral hepatitis B. Lancet. 2003 Dec 20;362(9401):2089-94. doi: 10.1016/S0140-6736(03)15108-2.
PubMed 14697813Trepo C, Chan HL, Lok A. Hepatitis B virus infection. Lancet. 2014 Dec 6;384(9959):2053-63. doi: 10.1016/S0140-6736(14)60220-8. Epub 2014 Jun 18.
PubMed 24954675Tassopoulos NC, Volpes R, Pastore G, Heathcote J, Buti M, Goldin RD, Hawley S, Barber J, Condreay L, Gray DF. Efficacy of lamivudine in patients with hepatitis B e antigen-negative/hepatitis B virus DNA-positive (precore mutant) chronic hepatitis B. Lamivudine Precore Mutant Study Group. Hepatology. 1999 Mar;29(3):889-96. doi: 10.1002/hep.510290321.
PubMed 10051494Marcellin P, Chang TT, Lim SG, Tong MJ, Sievert W, Shiffman ML, Jeffers L, Goodman Z, Wulfsohn MS, Xiong S, Fry J, Brosgart CL; Adefovir Dipivoxil 437 Study Group. Adefovir dipivoxil for the treatment of hepatitis B e antigen-positive chronic hepatitis B. N Engl J Med. 2003 Feb 27;348(9):808-16. doi: 10.1056/NEJMoa020681.
PubMed 12606735Chang TT, Lai CL, Kew Yoon S, Lee SS, Coelho HS, Carrilho FJ, Poordad F, Halota W, Horsmans Y, Tsai N, Zhang H, Tenney DJ, Tamez R, Iloeje U. Entecavir treatment for up to 5 years in patients with hepatitis B e antigen-positive chronic hepatitis B. Hepatology. 2010 Feb;51(2):422-30. doi: 10.1002/hep.23327.
PubMed 20049753Brouwer WP, Xie Q, Sonneveld MJ, Zhang N, Zhang Q, Tabak F, Streinu-Cercel A, Wang JY, Idilman R, Reesink HW, Diculescu M, Simon K, Voiculescu M, Akdogan M, Mazur W, Reijnders JG, Verhey E, Hansen BE, Janssen HL; ARES Study Group. Adding pegylated interferon to entecavir for hepatitis B e antigen-positive chronic hepatitis B: A multicenter randomized trial (ARES study). Hepatology. 2015 May;61(5):1512-22. doi: 10.1002/hep.27586. Epub 2015 Feb 27.
PubMed 25348661
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multicenter, Open-label Study Evaluating HBeAg Seroconversion in HBeAg Positive CHB Patients on Treatment With NA Switched to Combined Therapy With Peginterferon Alfa-2a and NA for 48 Weeks
- ClinicalTrials.gov ID
- NCT02474316
- Acronym / sponsor ID
- HOPE
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 366 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 17 Jun 2015 (estimated)
- 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 is a prospective, randomized, multicenter, open-label study. After more than 24 weeks NA treatment, HBeAg positive CHB patients who achieved HBV DNA<1000copies/ml but HBeAb negative, will be randomized (1:1) into 2 study arms as follows:
Arm A: Peginterferon alfa-2a 180μg /wk plus NA 1 piece qd for 48 weeks Arm B: Entecavir 0.5mg qd for 48 weeks
Detailed description
This is a prospective, randomized, multicenter, open-label study. After more than 24 weeks NA treatment, HBeAg positive CHB patients who achieved HBV DNA<1000copies/ml but HBeAb negative, will be randomized (1:1) into 2 study arms as follows:
Arm A: Peginterferon alfa-2a 180μg /wk plus NA 1piece qd for 48 weeks Arm B:NA 1 piece qd for 48 weeks
The primary endpoint: HBeAg seroconversion at week 48
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PegINF plus nucleos(i)de analgoue | Experimental | Drug: Peginterferon alfa-2a, Drug: nucleos(t)ide analgouePeginterferon alfa-2a 180μg /wk plus nucleos(t)ide analgoue (NA) 1 piece qd for 48 weeks |
| nucleos(t)ide analgoue | Active comparator | Drug: nucleos(t)ide analgouenucleos(t)ide analgoue (NA) 1 piece qd for 48 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female patients with age ≥18 and ≤65 years;
- There should be evidences that HBsAg and HBeAg have been positive for more than 6 months with HBsAb and HBeAb negative before treated with Entecavir;
- Treated with NA for more than 24 weeks and achieve HBV DNA<1000copies/ml with HBeAb negative;
- Women without ongoing pregnancy or breast feeding and willing to take an effective contraceptive measure during the treatment
- Agree to participate in the study and sign the patient informed consent.
Key exclusion criteria (25 listed)
- Co-infection with active hepatitisA, hepatitisC, hepatitisD and/or human immunodeficiency virus (HIV)
- AFP>50ng/ml and/or evidence of hepatocellular carcinoma
- Evidence of decompensated liver disease (Child-Pugh scores >5). Child-Pugh >5 means that, if one of the following 6 conditions is met, the patient has to be excluded:
- History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures, thalassemia)
- Pregnant or breast-feeding Women
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 |
|---|---|---|
| Peginterferon alfa-2aAlso: PegasysPeginterferon alfa-2a 180ug/wk s.c for 48 weeks | Drug | PegINF plus nucleos(i)de analgoue |
| nucleos(t)ide analgouenucleos(t)ide analgoue (NA) 1 piece p.o for 48 weeks | Drug | PegINF plus nucleos(i)de analgoue, nucleos(t)ide analgoue |
Primary outcome
Number of participants who achieve HBeAg seroconversion
Time frame: at week 48
To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve the HBeAg seroconversion in HBeAg positive CHB patients on treatment with Entecavir and with HBV DNA <1000copies/ml which will be measured by the number of participants who achieve HBeAg seroconversion
12 secondary outcomes
Number of participants who achieve HBeAg loss
Time frame: at week 48
Number of participants who achieve HBsAg loss
Time frame: at week 48
Number of participants who achieve HBsAg seroconversion
Time frame: at week 48
HBsAg decline from baseline
Time frame: at week 48
Percentage of participants who achieve HBsAg <1000IU/mL
Time frame: at week 48
Percentage of of participants who achieve HBsAg <100IU/mL
Time frame: at week 48
Number of participants who achieve combined response I (defined as HBeAg seroconversion and HBV DNA<100000copies/mL)
Time frame: at week 48
Number of participants who achieve combined response II (defined as HBeAg seroconversion and HBV DNA<1000copies/mL)
Time frame: at week 48
Number of participants who achieve dural response I (defined as HBeAg seroconversion and HBsAg<1000IU/mL)
Time frame: at week 48
Number of participants who achieve dural response II (defined as HBeAg seroconversion and HBsAg<100IU/mL)
Time frame: at week 48
Number of Participants with AE
Time frame: at week 48
Number of Participants with SAE
Time frame: at week 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
- Results publication: PubMed 14697813Lai CL, Ratziu V, Yuen MF, Poynard T. Viral hepatitis B. Lancet. 2003 Dec 20;362(9401):2089-94. doi: 10.1016/S0140-6736(03)15108-2.
- Results publication: PubMed 24954675Trepo C, Chan HL, Lok A. Hepatitis B virus infection. Lancet. 2014 Dec 6;384(9959):2053-63. doi: 10.1016/S0140-6736(14)60220-8. Epub 2014 Jun 18.
- Results publication: PubMed 10051494Tassopoulos NC, Volpes R, Pastore G, Heathcote J, Buti M, Goldin RD, Hawley S, Barber J, Condreay L, Gray DF. Efficacy of lamivudine in patients with hepatitis B e antigen-negative/hepatitis B virus DNA-positive (precore mutant) chronic hepatitis B. Lamivudine Precore Mutant Study Group. Hepatology. 1999 Mar;29(3):889-96. doi: 10.1002/hep.510290321.
- Results publication: PubMed 12606735Marcellin P, Chang TT, Lim SG, Tong MJ, Sievert W, Shiffman ML, Jeffers L, Goodman Z, Wulfsohn MS, Xiong S, Fry J, Brosgart CL; Adefovir Dipivoxil 437 Study Group. Adefovir dipivoxil for the treatment of hepatitis B e antigen-positive chronic hepatitis B. N Engl J Med. 2003 Feb 27;348(9):808-16. doi: 10.1056/NEJMoa020681.
- Results publication: PubMed 20049753Chang TT, Lai CL, Kew Yoon S, Lee SS, Coelho HS, Carrilho FJ, Poordad F, Halota W, Horsmans Y, Tsai N, Zhang H, Tenney DJ, Tamez R, Iloeje U. Entecavir treatment for up to 5 years in patients with hepatitis B e antigen-positive chronic hepatitis B. Hepatology. 2010 Feb;51(2):422-30. doi: 10.1002/hep.23327.
- Results publication: PubMed 25348661Brouwer WP, Xie Q, Sonneveld MJ, Zhang N, Zhang Q, Tabak F, Streinu-Cercel A, Wang JY, Idilman R, Reesink HW, Diculescu M, Simon K, Voiculescu M, Akdogan M, Mazur W, Reijnders JG, Verhey E, Hansen BE, Janssen HL; ARES Study Group. Adding pegylated interferon to entecavir for hepatitis B e antigen-positive chronic hepatitis B: A multicenter randomized trial (ARES study). Hepatology. 2015 May;61(5):1512-22. doi: 10.1002/hep.27586. Epub 2015 Feb 27.
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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.
Qing Xie study chair
Ruijin Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Peginterferon alfa-2a and nucleos(t)ide analgoue in people with Chronic Hepatitis B, run by Ruijin Hospital at 3 sites 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 25 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 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Qing Xie (86-13651804273, xieqingrjh2015@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who achieve HBeAg seroconversion (time frame: at week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02474316, which also lists 6 linked publications.
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 3 Dec 2015.