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Chronic Hepatitis BPhase 4NCT02560649

An Exploratory Study of RGT Strategy on Optimal NUC-experienced Patients

A Phase 4 study testing Peginterferon alfa-2a plus Entecavir, Peginterferon alfa-2a plus Lamivudine and Peginterferon alfa-2a plus Adefovir in people with Chronic Hepatitis B, run by Ruijin Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of current study is to investigate whether the HBsAg clearance rate can be improved if applying RGT((Response-Guided Therapy) strategy in HBeAg positive CHB(chronic hepatitis B) patients treated by nucleoside analogue(NUC) achieved HBVDNA<1000copies/ml，and HBsAg<5000IU/ml; \&HBeAg<100PEIU/ml (or470s/co)… 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 plus Entecavir, Peginterferon alfa-2a plus Lamivudine and Peginterferon alfa-2a plus Adefovir
Could I receive a placebo?
No, everyone receives an active treatment
How many people
324 participants
Where
No sites listed yet
Study dates
May 2015to Feb 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 nucleoside analogue(NUC) (except of telbivudine);
  • Treated with NUC (except of telbivudine)for more than 24 weeks and achieve HBV DNA<1000copies/ml and HBsAg<5000IU/ml；\&HBeAg<100PEIU/ml(470s/co);
  • Without contra-indications to Peginterferon alfa-2a therapy as detailed in the label;
  • Without co-infection with hepatitis C, hepatitis D and HIV;
  • 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 form.

Who cannot join

  • Co-infection with active hepatitis A, hepatitis C, hepatitis D and/or human immunodeficiency virus (HIV)
  • AFP(alpha fetoprotein)>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
  • Prothrombin time prolonged≥ 4 seconds or PTA(prothrombin activity) < 60%
  • Serum bilirubin > 34 µmol/L
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  • 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(absolute neutrophil count)<1.5x 10^9/L or PLT(platelet count)<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(telbivudine) 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

About this study

Official title: A Prospective, Randomized, Multicenter, Open-label, Exploratory Study of Utilizing of "Response-Guided-Therapy (RGT)" Strategy on Optimal Nucleoside Analogue (NUC)-Experienced Patients

The aim of current study is to investigate whether the HBsAg clearance rate can be improved if applying RGT((Response-Guided Therapy) strategy in HBeAg positive CHB(chronic hepatitis B) patients treated by nucleoside analogue(NUC) achieved HBVDNA<1000copies/ml，and HBsAg<5000IU/ml; \&HBeAg<100PEIU/ml (or470s/co), combined with PEG-IFN a-2a for 24 weeks.

Read the detailed description

The current study is a prospective, randomized, open, multi-center investigation. The aim of current study is to investigate whether the HBsAg clearance rate can be improved if applying RGT strategy in HBeAg positive CHB patients treated by NUC achieved HBVDNA<1000copies/ml，and HBsAg<5000IU/ml; \&HBeAg<100PEIU/ml (or470s/co), combined with PEG-IFN a-2a for 24 weeks. Then the subjects will be divided into three groups according to qHBsAg levels of week 24 (RGT). For the subjects who qHBsAg<200IU/ml of week 24, they are defined in Group A; the subjects in Group A will continue to be treated by NUC combined with PEG-IFN a-2a 180μg for another 24 weeks(total will be 48 weeks). If the qHBsAg at week 24 did not achieve minor 200IU/ml, the subjects will be randomized to 2 groups: Group B: the subjects will continue to be treated by NUC combined with PEG-IFN a-2a 180μg for another 24 weeks (total will be 48 weeks); Group C: the subjects will be treated by NUC until 48 weeks.

Being tested
Peginterferon alfa-2a plus Entecavir, Peginterferon alfa-2a plus Lamivudine, Peginterferon alfa-2a plus Adefovir, Peginterferon alfa-2a plus Tenofovir, 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.

  • Peginterferon alfa-2a plus EntecavirDrug

    Also called Pegasys; ETV

    Peginterferon alfa-2a 180μg /wk plus Entecavir 0.5mg qd for 48 weeks(Arm A and B)

  • Peginterferon alfa-2a plus LamivudineDrug

    Also called Pegasys; LAM

    Peginterferon alfa-2a 180μg /wk plus Lamivudine 0.1g qd for 48 weeks(Arm A and B)

  • Peginterferon alfa-2a plus AdefovirDrug

    Also called Pegasys;ADV

    Peginterferon alfa-2a 180μg /wk plus Adefovir 10mg qd for 48 weeks(Arm A and B)

  • Peginterferon alfa-2a plus TenofovirDrug

    Also called Pegasys;TDF

    Peginterferon alfa-2a 180μg /wk plus Tenofovir 300mg qd for 48 weeks(Arm A and B)

  • EntecavirDrug

    Also called ETV

    Entecavir 0.5mg qd for 24 weeks(Arm C)

  • LamivudineDrug

    Also called LAM

    Lamivudine 0.1g qd for 24 weeks(Arm C)

  • AdefovirDrug

    Also called Adefovir dipivoxil;ADV

    Adefovir 10mg qd for 24 weeks(ArmC)

  • Tenofovir disoproxilDrug

    Also called Tenofovir disoproxil;TDF

    Tenofovir 300mg qd for 24 weeks(Arm C)

Study groups in NCT02560649
Study groupRoleWhat they receive
A:PEG+NUC (HBsAg<200IU/ml at week 24)ExperimentalPeginterferon alfa-2a 180μg /wk plus nucleoside analogue(NUC): HBsAg<200IU/ml at week 24 (Following treatment with Peginterferon alfa-2a plus nucleoside analogue(NUC) for 24 weeks)
Receives: Drug: Peginterferon alfa-2a plus Entecavir; Drug: Peginterferon alfa-2a plus Lamivudine; Drug: Peginterferon alfa-2a plus Adefovir; Drug: Peginterferon alfa-2a plus Tenofovir
B:PEG+NUC(HBsAg>200IU/ml at week 24)Active comparatorPeginterferon alfa-2a 180μg /wk plus+nucleoside analogue(NUC): HBsAg>200IU/ml at week 24 (Following treatment with Peginterferon alfa-2a plus nucleoside analogue(NUC) for 24 weeks)
Receives: Drug: Peginterferon alfa-2a plus Entecavir; Drug: Peginterferon alfa-2a plus Lamivudine; Drug: Peginterferon alfa-2a plus Adefovir; Drug: Peginterferon alfa-2a plus Tenofovir
C:NUC(HBsAg>200IU/ml at week 24)Active comparatornucleoside analogue(NUC): HBsAg>200IU/ml at week 24 (Following treatment with Peginterferon alfa-2a plus nucleoside analogue(NUC) for 24 weeks)
Receives: Drug: Entecavir; Drug: Lamivudine; Drug: Adefovir; Drug: Tenofovir disoproxil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants who achieve HBsAg clearance

    To investigate whether HBsAg clearance rate can be improved at week 48 following applying RGT strategy(week 24) in NUC-experience subjects will be measured by the number of participants who achieve HBsAg clearance

    Measured: Week 48

Secondary outcomes (11)

  1. Number of participants who achieve HBsAg seroconversion

    To investigate the HBsAg seroconversion rate at week 48 can be improved following applying RGT strategy in NUC-experience subjects will be measured by the number of participants who achieve HBsAg seroconversion

    Measured: Week 48

  2. Number of participants who achieve HBeAg loss

    To investigate the HBeAg loss rate at week 48 can be improved following applying RGT strategy in NUC-experience subjects will be measured by the number of participants who achieve HBeAg loss

    Measured: Week 48

  3. Number of participants who achieve HBeAg seroconversion

    To investigate the HBeAg seroconversion rate at week 48 will be improved following applying RGT strategy in NUC-experience subjects will be measured by the number of participants who achieve HBeAg seroconversion

    Measured: Week 48

  4. Percentage of of participants who achieve HBsAg decline >2log from baseline(0 week)

    To investigate HBsAg decline from baseline at week 48 following applying RGT strategy in NUC-experience subjects by measured the percentage of of participants who achieve HBsAg decline>2log from baseline(0 week)

    Measured: Week 48

  5. Percentage of of participants who achieve HBsAg <10IU/mL

    To investigate the percentage of of participants who achieve HBsAg <100IU/mLat week 48 following applying RGT strategy in NUC-experience subjects

    Measured: Week 48

  6. Percentage of of participants who achieve combined response(defined as HBeAg seroconversion and HBVDNA<300copies/mL)

    To investigate the percentage of of participants who achieve combined response at week 48 following applying RGT strategy in NUC-experience subjects will be measured by number of participants who achieve combined response

    Measured: Week 48

  7. Percentage of of participants who achieve dural response I (defined as HBeAg seroconversion and HBsAg<100IU/mL)

    To investigate the percentage of of participants who achieve dural response I at week 48 following applying RGT strategy in NUC-experience subjects will be measured by number of participants who achieve dural response

    Measured: Week 48

  8. Percentage of of participants who achieve dural response II (defined as HBeAg seroconversion and HBsAg<10IU/mL)

    To investigate the percentage of of participants who achieve dural response II at week 48 following applying RGT strategy in NUC-experience subjects will be measured by number of participants who achieve dural response

    Measured: Week 48

  9. Number of participants who relapses (HBVDNA>1000copies/ml)

    To investigate the number of participants who relapses following applying RGT strategy in NUC-experience subjects

    Measured: Week 48

  10. Number of Participants with AE

    Number of participants with adverse events as a measure of safety and tolerability

    Measured: Week 48

  11. Number of Participants with SAE

    Number of participants with SAEs as a measure of safety and tolerability

    Measured: Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionAug 2016 (estimated)
  4. Study completionFeb 2017 (estimated)

Resources

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
Masking
None (open label)
Enrolment
324 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02560649
Sponsor's protocol ID
PYRAMID
Status last verified
Sep 2015
First submitted
22 Sep 2015
Last updated
25 Sep 2015
Results posted
No

Publications

  • Ning Q, Han M, Sun Y, Jiang J, Tan D, Hou J, Tang H, Sheng J, Zhao M. Switching from entecavir to PegIFN alfa-2a in patients with HBeAg-positive chronic hepatitis B: a randomised open-label trial (OSST trial). J Hepatol. 2014 Oct;61(4):777-84. doi: 10.1016/j.jhep.2014.05.044. Epub 2014 Jun 7.

    PubMed 24915612

  • P. Hu et al. 2015 EASL abstract O116. PREDICTIVE VALUE OF BASELINE AND ON-TREATMENT qHBsAg LEVEL IN HBeAg POSITIVE CHB PATIENTS WHO SWITCHED FROM NUCS TO PEGYLATED INTERFERON A-2A: A FURTHER ANALYSIS FROM NEW SWITCH STUDY

  • Brouwer 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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Peginterferon alfa-2a plus Entecavir, Peginterferon alfa-2a plus Lamivudine and Peginterferon alfa-2a plus Adefovir in people with Chronic Hepatitis B, run by Ruijin Hospital.

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 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 25 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants who achieve HBsAg clearance (time frame: 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 NCT02560649, which also lists 3 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 25 Sep 2015.

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