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Hepatitis B, ChronicPhase 4NCT02360592

Combination Therapy With Interferon Plus Interleukin 2 and Hepatitis B Vaccine in Chronic Hepatitis B Patients

A Phase 4 study testing Entecavir, Interferon alfa-2b and Interleukin 2 in people with Hepatitis B, Chronic, run by Tongji Hospital at 12 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a multi-center, randomized, prospective, open-label Phase IV Clinical trial to evaluate efficacy and safety of interferon alfa-2b therapy combinated with interleukin 2 and hepatitis B therapeutic vaccine versus interferon alfa-2b alone in chronic hepatitis B patients with entecavir achieving HBeAg… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hepatitis B, Chronic
What is being tested?
Entecavir, Interferon alfa-2b and Interleukin 2
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
12 sitesChina
Study dates
Jun 2013to Apr 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 from 18 to 65 years of age;
  • Undergoing treatment with entecavir for at least 1 year ;
  • HBsAg(+), HBeAg(+), HBV DNA≥ 100000 copies/ml，ALT≥2 ULN and ≤10 ULN before receiving entecavir treatment;
  • HBV DNA ≤1000 copies/mL;
  • HBeAg (-);
  • HBsAg (+);
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  • Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug;
  • Liver biopsy confirmed without cirrhosis (optional);
  • Agree to participate in the study and sign the patient informed consent.

Who cannot join

  • Patients who had NAs resistance;
  • Other antiviral, anti-neoplastic or immunomodulatory treatment (including supra physiologic doses of steroids and radiation) 6 months prior to the first dose of randomized treatment (except for 7 days of acyclovir for herpetic lesions more than 1 month prior to first administration of randomized treatment). Patients who are expected to need systemic antiviral therapy other than that provided by the study at any time during their participation are also excluded;
  • Women with ongoing pregnancy or breast-feeding;
  • Co-infection with active hepatitis A, hepatitis C, hepatitis D(Those hospitals which have the ability to do the test will do) and/or human immunodeficiency virus (HIV);
  • ALT >10 ULN;
  • Evidence of decompensated liver disease (Child-Pugh score > 5 ). Child-Pugh > 5 means, if one of the following 6 conditions are met, the patient has to be excluded: a. Serum albumin < 3.5 g/L; b. Prothrombin time > 3 seconds prolonged; c. Serum bilirubin > 34 μ mol/L; d. History of encephalopathy; e. History of variceal bleeding; f. Ascites;
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  • 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);
  • Signs or symptoms of hepatocellular carcinoma, patients with a value of alpha-fetoprotein > 100 ng/mL are excluded, unless stability (less than 10% increase) has been documented over at least the previous 3 months. Patients with values < 20 ng/mL but > 100 ng/mL may be enrolled, if hepatic neoplasia has been excluded by liver imaging;
  • Neutrophil count < 1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening;
  • Hemoglobin < 11.5 g/dL for females and <12.5 g/dL for men;
  • Serum creatinine level > 1.5 ULN in screening period.
  • Phosphorus < 0.65 mmol/L;
  • ANA > 1:100;
  • History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at herapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time 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 a severe seizure disorder or current anticonvulsant use;
  • History of immunologically mediated disease, (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, rheumatoid arthritis etc.);
  • History of chronic pulmonary disease associated with functional limitation;
  • Diseases that IFN and Nucleotides or nucleosides are not suitable.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

China12 sites

  • BeiJing YouAn Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • First Hospital, Beijing University

    Beijing, Beijing Municipality

  • People'S Hospital Under Beijing University

    Beijing, Beijing Municipality

  • Departmen of infectious disease, Xiangya Hospital, Central-south Universit

    Changsha, Hunan

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian

  • Department of infectious disease, Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong

  • The First Affiliated Hospital of College of Medicine, Zhejiang University

    Hangzhou, Zhejiang

  • Anhui Provincial Hospital

    Hefei, Anhui

  • Shanghai Ruijin Hospital, Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality

  • ShengJing Hospital of China Medical University

    Shenyang, Liaoning

  • The first affiliated hospital of Wenzhou medical universtiy

    Wenzhou, Zhejiang

  • Tongji Hospital

    Wuhan, Hubei, 430030

Other trials in China

About this study

Official title: Combination Therapy of Interferon Alfa-2b Plus Interleukin 2 and Hepatitis B Vaccine in Entecavir-experienced Chronic Hepatitis B Patients With HBeAg Seroclearance: a Prospective, Randomized Open-label Trial (Endeavor Study, a Pilot Study)

This study is a multi-center, randomized, prospective, open-label Phase IV Clinical trial to evaluate efficacy and safety of interferon alfa-2b therapy combinated with interleukin 2 and hepatitis B therapeutic vaccine versus interferon alfa-2b alone in chronic hepatitis B patients with entecavir achieving HBeAg seroclearance. Patients were randomized to one of 3 groups to receive different antiviral treatment.

Read the detailed description

Patients who have been pretreated with entecavir for at least one year, with HBV (Hepatitis B Virus) DNA less than 1000 copies/ml and HBeAg seroclearance were randomized to one of 3 groups, to receive Entecavir 0.5 mg po daily for 72 weeks, or Interferon alfa-2b 600wIU qod iH for 48 weeks plus Entecavir 0.5mg qd po for 8 weeks, or Interferon alfa-2b 600wIU qod iH for 48 weeks plus Entecavir 0.5mg qd po for 8 weeks plus interleukin 2 25 wIU qod iH for 12 weeks plus Hepatitis B Vaccine 60ug qm im for 48 weeks.

Being tested
Entecavir, Interferon alfa-2b, Interleukin 2, Hepatitis B Vaccine
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.

  • EntecavirDrug

    Also called ETV

    In arm 1, Entecavir is used for 48 weeks and the follow up 24 weeks as conventional control, In arm 2 and 3, Entecavir is used for 8 weeks.

  • Interferon alfa-2bDrug

    Also called IFN a-2b

    In arm 2 and 3, interferon alfa-2b is used for 48 weeks

  • Interleukin 2Drug

    Also called IL-2

    In arm 3, Interleukin 2 is used for 12 weeks

  • Hepatitis B VaccineDrug

    In arm 3, Hepatitis B Vaccine is used for 48 weeks

Study groups in NCT02360592
Study groupRoleWhat they receive
1, conventional control groupActive comparatorEntecavir 0.5 mg po daily for 72 weeks
Receives: Drug: Entecavir
2, combination and sequential groupExperimentalInterferon alfa-2b 600wIU qod iH for 48 weeks plus Entecavir 0.5mg qd po for 8 weeks
Receives: Drug: Entecavir; Drug: Interferon alfa-2b
3, multitarget groupExperimentalInterferon alfa-2b 600wIU qod iH for 48 weeks plus Entecavir 0.5mg qd po for 8 weeks plus interleukin 2 25 wIU qod iH for 12 weeks plus Hepatitis B Vaccine 60ug qm im for 48 weeks
Receives: Drug: Entecavir; Drug: Interferon alfa-2b; Drug: Interleukin 2; Drug: Hepatitis B Vaccine

What is being measured

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

  1. Percentage of HBsAg loss at week 48

    Change from baseline in Percentage of HBsAg loss at week 48

    Measured: week 48

Secondary outcomes (2)

  1. decline from baseline in HBsAg quantification at week 48

    HBsAg quantification are measured.

    Measured: week 48

  2. Change from baseline in HBsAg seroconversion at week 48

    HBsAg seroconversion from baseline is measured.

    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 posted10 Feb 2015 (estimated)
  2. Study startJun 2013
  3. Primary completionDec 2016
  4. Study completionApr 2017

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
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02360592
Sponsor's protocol ID
Endeavor study, a pilot study
Status last verified
Oct 2017
First submitted
2 Feb 2015
Last updated
9 May 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Entecavir, Interferon alfa-2b and Interleukin 2 in people with Hepatitis B, Chronic, run by Tongji Hospital at 12 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 9 inclusion and 18 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: finished, as of the sponsor's last update on 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percentage of HBsAg loss at week 48 (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 NCT02360592.

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 9 May 2018.

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