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Chronic HepatitisPhase 4NCT03013556

Study on an Optimal Antiviral Treatment in HBeAg Positive Chronic Hepatitis B Patients

A Phase 4 study testing Group A, TDF, Group B:TDF then TDF and Peginterferon alfa-2a and Group C:TDF and Peginterferon alfa-2a then TDF in people with Chronic Hepatitis, run by Ruijin Hospital at 8 sites in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 current study is a prospective, randomized, open, multi-center investigation. The aim of the study is to investigate whether the HBeAg seroconversion rate can be improved if applying combination therapy in HBeAg positive CHB patients who has achieved HBVDNA<105copies/ml，HBsAg≤5000IU/ml, ALT≥ 2ULN or Liver… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Hepatitis
What is being tested?
Group A, TDF, Group B:TDF then TDF and Peginterferon alfa-2a and Group C:TDF and Peginterferon alfa-2a then TDF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
8 sitesChina
Study dates
Nov 2016to 31 Dec 2021
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;HBsAg≤50000IU/ml, ALT≥ 2ULN,Liver histology above G2S2 and HBV DNA≥10*5 copies/mL;
  • Women without ongoing pregnancy or breast feeding and both women and men 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

  • Treated by immunosuppressant,immunomodulator,Systemic cytotoxic drug,herbs or HBIg within 6 months prior to the first dose of treatment;
  • ALT≥10 X ULN or total bilirubin ≥2 X ULN;
  • Allergic history to interferon;
  • Co-infection with active hepatitis A, hepatitis C, hepatitis D and/or human immunodeficiency virus (HIV);
  • Child-Pugh scores >7;
  • 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);
Show all 23Show fewer
  • Pregnant or breast-feeding Women;
  • Consuming alcohol in excess of 20g/day for women and 30g/day for men within 6 months prior to enrollment or drug taking history;
  • ANC(absolute neutrophil count)<1.5x 10^9/L or PLT(platelet count)<90x 10^9/L
  • Creatinine over upper limit of normal;
  • 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 severe cardiac disease (e.g., New York Heart Association 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;
  • Patients included in another trial or having been given investigational drugs within 12 weeks prior to screening;
  • AFP(alpha feto protein)>50ng/ml and/or evidence of hepatocellular carcinoma;
  • Other disease should exclusive considered by the investigator.

Trial locations and contacts

8 sites in 1 country.

Xinxin Zhang contact

zhangx@shsmu.edu.cn

8 sites in 1 country

China8 sites, 8 recruiting

  • Xixi Hospital of Hangzhou

    Hangzhou

    Xiaoqing Fu

    Recruiting

  • Changhai Hospital

    Shanghai

    Mobin Wan, mobinwan@aliyun.com

    Recruiting

  • Hua shan Hospital,Fudan University

    Shanghai

    Jiming Zhang, jmzhang@vip.126.com

    Recruiting

  • Infectious diesease hospital of Huangpu district in Shanghai

    Shanghai

    Hailin Liang

    Recruiting

  • No.9 hospital of shanghai

    Shanghai

    Jie Xu, dr.xu@aliyun.com

    Recruiting

  • Shanghai public health clinical center

    Shanghai

    Liang Chen, chenliang@shaphc.org

    Recruiting

  • Shuguang Hospital of Shanghai T.C.M

    Shanghai

    yueqiu Gao, gaoyueqiu@hotmail.com

    Recruiting

  • Tongren hospital Shanghai Jiaotong University School of medicine

    Shanghai

    Qin Zhang

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Randomized, Multicenter, Open-label Study of Optimal Antiviral Treatment in HBeAg Positive Chronic Hepatitis B Patients

The current study is a prospective, randomized, open, multi-center investigation. The aim of the study is to investigate whether the HBeAg seroconversion rate can be improved if applying combination therapy in HBeAg positive CHB patients who has achieved HBVDNA<105copies/ml，HBsAg≤5000IU/ml, ALT≥ 2ULN or Liver histology G2S2.

Read the detailed description

The HBeAg positive chronic hepatitis B(CHB) subjects who has achieved HBV DNA<10*5copies/ml，HBsAg≤5000IU/ml, ALT≥ 2ULN or Liver histology G2S2 will be randomized to three groups. The subjects who go into group A will be treated by tenofovir disoproxil fumarate (TDF) for 96 weeks; The subjects who go into group B will be treated by TDF in the first 48 weeks, then will be treated by the combination of TDF and Peginterferon alfa-2a for another 48 weeks; The subjects who go into group C will be treated by the combination of TDF and Peginterferon alfa-2a for the first 48 weeks, then will be treated by TDF for another 48 weeks.

Being tested
Group A, TDF, Group B:TDF then TDF and Peginterferon alfa-2a, Group C:TDF and Peginterferon alfa-2a then TDF
Keywords
HBeAg positive
Medical subject headings
Hepatitis, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group A, TDFDrug

    Also called tenofovir

    TDF for 96 weeks

  • Group B:TDF then TDF and Peginterferon alfa-2aDrug

    Also called tenofovir,pegasys

    Subjects will be treated by TDF in the first 48 weeks, then will be treated by the combination of TDF and Peginterferon alfa-2a for another 48 weeks

  • Group C:TDF and Peginterferon alfa-2a then TDFDrug

    Also called tenofovir,pegasys

    Subjects will be treated by the combination of TDF and Peginterferon alfa-2a for the first 48 weeks, then will be treated by TDF for another 48 weeks.

Study groups in NCT03013556
Study groupRoleWhat they receive
Group A,TDFActive comparatorThe subjects in group A will be treated by TDF for 96 weeks
Receives: Drug: Group A, TDF
Group B,TDF+PEGExperimentalThe subjects in group B will be treated by TDF in the first 48 weeks, then will be treated by the combination of TDF and Peginterferon alfa-2a for another 48 weeks
Receives: Drug: Group B:TDF then TDF and Peginterferon alfa-2a
Group C,TDF+PEGExperimentalThe subjects in group C will be treated by the combination of TDF and Peginterferon alfa-2a for the first 48 weeks, then will be treated by TDF for another 48 weeks
Receives: Drug: Group C:TDF and Peginterferon alfa-2a then TDF

What is being measured

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

  1. Number of subjects who achieve HBeAg seroconversion

    The number of subjects with HBeAg seroconversion at week 96 will be measured

    Measured: at 96 week

Secondary outcomes (6)

  1. Number of participants who achieve HBeAg seroconversion

    The number of subjects with HBeAg seroconversion at week 48 and 72 will be measured

    Measured: at 48 week;at 72 week

  2. The percentage decrease of HBsAg level at group A,B,C

    The level of HBsAg in group A,B,C at week 48 ,72 and 96 will be measured,changing from baseline

    Measured: at 48 week;at 72 week;at 96 week

  3. Number of participants who achieve HBeAg loss

    The number of subjects with HBeAg loss at week48.72 and 96 will be measured

    Measured: at 48 week;at 72 week;at 96 week

  4. The number of subjects who achieve HBVDNA undetectable

    The number of subjects with HBVDNA undetectable at week 24,48,72 and 96 will be measured

    Measured: at 24 week;48 week;at 72 week;at 96 week

  5. The factor such as HBsAg level related to responsible rate

    The HBsAg level at week 48,72,96 will be measured, to assess whether the quantitative HBsAg level related to the responsible rate

    Measured: at week 48,72,96

  6. The number of subjects who achieve ALT back to normal

    The number of subjects with normal ALT at week 48,72 and 96 will be measured

    Measured: at 48 week;at 72 week;at 96 week

Timeline

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

  1. First posted6 Jan 2017 (estimated)
  2. Study startNov 2016
  3. Primary completion30 Dec 2021 (estimated)
  4. Study completion31 Dec 2021 (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
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03013556
Sponsor's protocol ID
SHDC12016101
Status last verified
Sep 2021
First submitted
16 Dec 2016
Last updated
22 Sep 2021
Results posted
No

Publications

  • Marcellin P, Ahn SH, Ma X, Caruntu FA, Tak WY, Elkashab M, Chuang WL, Lim SG, Tabak F, Mehta R, Petersen J, Foster GR, Lou L, Martins EB, Dinh P, Lin L, Corsa A, Charuworn P, Subramanian GM, Reiser H, Reesink HW, Fung S, Strasser SI, Trinh H, Buti M, Gaeta GB, Hui AJ, Papatheodoridis G, Flisiak R, Chan HL; Study 149 Investigators. Combination of Tenofovir Disoproxil Fumarate and Peginterferon alpha-2a Increases Loss of Hepatitis B Surface Antigen in Patients With Chronic Hepatitis B. Gastroenterology. 2016 Jan;150(1):134-144.e10. doi: 10.1053/j.gastro.2015.09.043. Epub 2015 Oct 8.

    PubMed 26453773

  • Xie Q, Zhou H, Bai X, Wu S, Chen JJ, Sheng J, Xie Y, Chen C, Chan HL, Zhao M. A randomized, open-label clinical study of combined pegylated interferon Alfa-2a (40KD) and entecavir treatment for hepatitis B "e" antigen-positive chronic hepatitis B. Clin Infect Dis. 2014 Dec 15;59(12):1714-23. doi: 10.1093/cid/ciu702. Epub 2014 Sep 4.

    PubMed 25190434

  • 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 Group A, TDF, Group B:TDF then TDF and Peginterferon alfa-2a and Group C:TDF and Peginterferon alfa-2a then TDF in people with Chronic Hepatitis, run by Ruijin Hospital at 8 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 4 inclusion and 23 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 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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 Xinxin Zhang (zhangx@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of subjects who achieve HBeAg seroconversion (time frame: at 96 week). 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 NCT03013556, 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 22 Sep 2021.

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