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Chronic Hepatitis BPhase 4NCT02594293

Pegylated Interferon(Peg-IFN) in Reducing Relapse Rate in Patients After Discontinuation of NUC Therapy

A Phase 4 study testing PegIFN alfa-2a in people with Chronic Hepatitis B, run by Huashan Hospital at 19 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 evaluates whether Peg-IFN alfa-2a can reduce the recurrence rate of hepatitis B in 96 weeks after nucleoside analogue (NUC) withdrawal. The HBV HBeAg-Negative patients who received NUC anti-virus treatment for 2.5 years and reached stopping rule in 《Chinese chronic hepatitis B prevention and treatment… 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?
PegIFN alfa-2a
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
19 sitesChina
Study dates
Oct 2015to Sep 2022
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

  • HBeAg-Negative Chronic Hepatitis B Patients：HBsAg-Positive,HBsAb-Negative,HBeAg-Negative,HBeAb-Positive during screening period and before NA treatment
  • NUC monotherapy (including adefovir and entecavir) for more than 2.5 years,and reached stopping rule in 《Chinese chronic hepatitis B prevention and treatment guidelines》(2010):the patients who achieved undetectable HBV DNA (<300 copies/mL) with normal alanine aminotransferase (ALT) and the consolidation therapy reached 1.5 years ,total course of the treatment reached 2.5 years can stop NUC therapy
  • Willing to stop the drug, and signed a written informed consent

Who cannot join

  • HBsAb positive in screening period
  • Compensated or Decompensated liver cirrhosis:with history of cirrhosis before NUC treatment or Child-Pugh score ≥ 5 or Complications of liver cirrhosis such as ascites, hepatic encephalopathy, esophageal gastric varices bleeding
  • Hypersensitivity to interferon(IFN) or its active substance, and ineligible to IFN
  • A history of immunoregulation drug therapy within one year before entry including IFN and so on.
  • Coinfection with HAV、HCV、HDV、HEV 、HIV or with Other chronic liver diseases such as Alcoholic Liver Disease,Inherited Metabolic Liver Disease,Drug induced Liver Disease and nonalcoholic fatty liver
  • Autoimmune disease including Autoimmune hepatitis and Psoriasis and so on.
Show all 16Show fewer
  • Hepatocellular carcinoma(HCC) or alpha feto protein(AFP) levels more than 100 ng/ml and Hepatic malignant potential of Imaging examination or AFP levels more than 100 ng/ml for 3 months
  • A neutrophil count of less than 1500 per cubic millimeter or a platelet count of less than 90,000 per cubic millimeter
  • A serum creatinine level that was more than 1.5 times the upper limit of the normal range
  • With other malignant tumors(exclude the cured ones)
  • Severe organ dysfunction
  • With severe psychiatric condition or nervous disease such as epilepsy, depression, mania, epilepsy, schizophrenia and so on
  • Uncontrolled diabetes, hypertension or thyroid disease
  • Pregnant women and lactating women or patients with pregnancy plans and not willing to use contraception during the study period
  • Participate in other clinical studies at the same time
  • Patients unsuitable for the research

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

China19 sites

  • Changzhou Third People's Hospital

    Changzhou, Jiangsu

  • First Affiliated Hospital of Zhejiang University

    Hangzhou, Jiangsu

  • Shandong Provincial Hospital

    Jinan, Shandong

  • People's Hospital of Jiangsu Province

    Nanjing, Jiangsu

  • Nantong Third People's Hospital

    Nantong, Jiangsu

  • Changhai Hospital Affiliated to Second Military Medical University

    Shanghai

  • Huashan Hospital Affiliated to Fudan University

    Shanghai

  • Ruijin Hospital Affiliate to Shanghai Jiao Tong University School of Medicine

    Shanghai

  • Shanghai Public Health Clinical Center

    Shanghai

  • Shanghai Third People's Hospital

    Shanghai

  • Shuguang Hospital Affiliate to Shanghai University of Traditional Chinese Medicine

    Shanghai

  • The Infectious Disease Hospital of Shanghai Huangpu Distric

    Shanghai

  • Suzhou Fifth People's Hospital

    Suzhou, Jiangsu

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu

  • Taicang People's Hospital

    Taicang, Jiangsu

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

  • Wuhan Seventh People's Hospital

    Wuhan, Hubei

  • Wuxi Infectious Disease Hospital

    Wuxi, Jiangsu

  • Affiliated Hospital of Xuzhou Medical College

    Xuzhou, Jiangsu

Other trials in China

About this study

Official title: A Prospective, Randomized, Controlled Clinical Trial to Evaluate the Role of Peg-IFN Alfa-2a in Reducing RelapSe Rate in Patients With Hepatitis B e Antigen(HBeAg)-nEgative Chronic Hepatitis B After Discontinuation of NUC Therapy

This study evaluates whether Peg-IFN alfa-2a can reduce the recurrence rate of hepatitis B in 96 weeks after nucleoside analogue (NUC) withdrawal.

The HBV HBeAg-Negative patients who received NUC anti-virus treatment for 2.5 years and reached stopping rule in 《Chinese chronic hepatitis B prevention and treatment guidelines》(2010) were randomly assigned into three groups: One group discontinue the NUC treatment and follow up for 96 weeks,One discontinue the NUC treatment ,receive Peg-IFN alfa-2a 180 μg by week for 24 weeks and follow up for 72 weeks,The other discontinue the NUC treatment ,receive Peg-IFN alfa-2a 180 μg by week for 48 weeks and follow up for 48 weeks.

Read the detailed description

NUC is a potent inhibitor of hepatitis B viral(HBV) replication, but long-term therapy may be required. Therefore, NUC resistance is an important clinical risk resulting from long-term therapy in chronic hepatitis B (CHB) management. Discontinuation of NUC is a feasible strategy to reduce resistance. However, the high rate of relapse after cessation of NUC treatment in CHB patients remains a big problem. NUC treatment of how to safely stop drug needs to be solved.

Peg-IFN can clear HBV by direct anti-viral and immune regulation mechanisms including enhancing natural killer cell response, increased cluster of differentiation 8(CD8 +) T lymphocytes and other mechanisms to restore and enhance the immune response in patients with CHB. Response to PEG-IFN is frequently sustained after a finite treatment course due to its immune modulating capacity.

Being tested
PegIFN alfa-2a
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.

  • PegIFN alfa-2aDrug

    Also called Pegasys

    180 μg/ 0.5 ml ,hypodermic injection once a week

Study groups in NCT02594293
Study groupRoleWhat they receive
Controlled GroupNo interventionDiscontinue the NA treatment and follow up for 96 weeks
Pegasys 48 weeksExperimentalDiscontinue the NA treatment ,PegIFN alfa-2a 180 μg by week for 48 weeks and follow up for 48 weeks
Receives: Drug: PegIFN alfa-2a

What is being measured

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

  1. Number of participants who relapse

    The total number of relapse (HBV DNA>2000 IU/ml on 2 separate occasions 1 months apart) during the research period.

    Measured: 96 weeks

Secondary outcomes (5)

  1. Number of participants who relapse

    The total number of relapse (HBV DNA>2000 IU/ml on 2 separate occasions 1 months apart) during the research period.

    Measured: 48 weeks

  2. Number of participants who achieve HBsAg seroconversion

    To investigate whether Peg-IFN alfa-2a can improve the HBsAg seroconversion in CHB patients at the point of discontinuation of PegIFN therapy compared to the control group ,which will be measured by the number of participants who achieve HBsAg seroconversion. Pegasys 24 weeks Group:24 weeks and Pegasys 48 weeks Group:48 weeks

    Measured: At the point of discontinuation of PegIFN therapy

  3. Number of participants who achieve HBsAg seroconversion

    To investigate whether Peg-IFN alfa-2a can improve the HBsAg seroconversion in CHB patients at 24,48 or 72 weeks post-discontinuation of PegIFN therapy compared to the control group ,which will be measured by the number of participants who achieve HBsAg seroconversion. Pegasys 24 weeks Group:48,72,96 weeks and Pegasys 48 weeks Group:72,96 weeks

    Measured: 24,48,72 weeks post-discontinuation of PegIFN therapy

  4. HBsAg changes from Baseline

    Pegasys 24 weeks Group:12,24 weeks and Pegasys 48 weeks Group:12,24,48 weeks

    Measured: 12,24 and 48 weeks

  5. Predictive value of other markers for recurrence after NUC withdrawal

    To investigate whether the other markers including HBcAb quantification and so on can predict the recurrence of hepatitis B.

    Measured: 48 weeks and 96 weeks

Timeline

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

  1. First posted3 Nov 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionSep 2022
  4. Study completionSep 2022

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02594293
Sponsor's protocol ID
CEASE
Status last verified
Oct 2022
First submitted
11 Oct 2015
Last updated
31 Oct 2022
Results posted
No
Data monitoring committee
No

Publications

  • Ganem D, Prince AM. Hepatitis B virus infection--natural history and clinical consequences. N Engl J Med. 2004 Mar 11;350(11):1118-29. doi: 10.1056/NEJMra031087. No abstract available.

    PubMed 15014185

  • Liang X, Bi S, Yang W, Wang L, Cui G, Cui F, Zhang Y, Liu J, Gong X, Chen Y, Wang F, Zheng H, Wang F, Guo J, Jia Z, Ma J, Wang H, Luo H, Li L, Jin S, Hadler SC, Wang Y. Epidemiological serosurvey of hepatitis B in China--declining HBV prevalence due to hepatitis B vaccination. Vaccine. 2009 Nov 5;27(47):6550-7. doi: 10.1016/j.vaccine.2009.08.048. Epub 2009 Sep 1.

    PubMed 19729084

  • Liang X, Bi S, Yang W, Wang L, Cui G, Cui F, Zhang Y, Liu J, Gong X, Chen Y, Wang F, Zheng H, Wang F, Guo J, Jia Z, Ma J, Wang H, Luo H, Li L, Jin S, Hadler SC, Wang Y. Evaluation of the impact of hepatitis B vaccination among children born during 1992-2005 in China. J Infect Dis. 2009 Jul 1;200(1):39-47. doi: 10.1086/599332.

    PubMed 19469708

  • Lu FM, Zhuang H. Management of hepatitis B in China. Chin Med J (Engl). 2009 Jan 5;122(1):3-4. No abstract available.

    PubMed 19187608

  • European Association For The Study Of The Liver. EASL clinical practice guidelines: Management of chronic hepatitis B virus infection. J Hepatol. 2012 Jul;57(1):167-85. doi: 10.1016/j.jhep.2012.02.010. Epub 2012 Mar 20. No abstract available.

    PubMed 22436845

  • Lok AS, McMahon BJ. Chronic hepatitis B: update 2009. Hepatology. 2009 Sep;50(3):661-2. doi: 10.1002/hep.23190. No abstract available.

    PubMed 19714720

  • Liaw YF, Leung N, Kao JH, Piratvisuth T, Gane E, Han KH, Guan R, Lau GK, Locarnini S; Chronic Hepatitis B Guideline Working Party of the Asian-Pacific Association for the Study of the Liver. Asian-Pacific consensus statement on the management of chronic hepatitis B: a 2008 update. Hepatol Int. 2008 Sep;2(3):263-83. doi: 10.1007/s12072-008-9080-3. Epub 2008 May 10.

    PubMed 19669255

  • 中华医学会肝病学分会,中华医学会感染病学分会.慢性乙型肝炎防治指南(2010年版).中华内科杂志,2011;50(2):168-179

  • Kim YJ, Kim K, Hwang SH, Kim SS, Lee D, Cheong JY, Cho SW. Durability after discontinuation of nucleos(t)ide therapy in chronic HBeAg negative hepatitis patients. Clin Mol Hepatol. 2013 Sep;19(3):300-4. doi: 10.3350/cmh.2013.19.3.300. Epub 2013 Sep 30.

    PubMed 24133668

  • Liu F, Wang L, Li XY, Liu YD, Wang JB, Zhang ZH, Wang YZ. Poor durability of lamivudine effectiveness despite stringent cessation criteria: a prospective clinical study in hepatitis B e antigen-negative chronic hepatitis B patients. J Gastroenterol Hepatol. 2011 Mar;26(3):456-60. doi: 10.1111/j.1440-1746.2010.06492.x.

    PubMed 21332542

  • Seto WK, Hui AJ, Wong VW, Wong GL, Liu KS, Lai CL, Yuen MF, Chan HL. Treatment cessation of entecavir in Asian patients with hepatitis B e antigen negative chronic hepatitis B: a multicentre prospective study. Gut. 2015 Apr;64(4):667-72. doi: 10.1136/gutjnl-2014-307237. Epub 2014 May 15.

    PubMed 24833635

  • Jeng WJ, Sheen IS, Chen YC, Hsu CW, Chien RN, Chu CM, Liaw YF. Off-therapy durability of response to entecavir therapy in hepatitis B e antigen-negative chronic hepatitis B patients. Hepatology. 2013 Dec;58(6):1888-96. doi: 10.1002/hep.26549. Epub 2013 Oct 17.

    PubMed 23744454

  • Micco L, Peppa D, Loggi E, Schurich A, Jefferson L, Cursaro C, Panno AM, Bernardi M, Brander C, Bihl F, Andreone P, Maini MK. Differential boosting of innate and adaptive antiviral responses during pegylated-interferon-alpha therapy of chronic hepatitis B. J Hepatol. 2013 Feb;58(2):225-33. doi: 10.1016/j.jhep.2012.09.029. Epub 2012 Oct 6.

    PubMed 23046671

  • Chen J, Wang Y, Wu XJ, Li J, Hou FQ, Wang GQ. Pegylated interferon alpha-2b up-regulates specific CD8+ T cells in patients with chronic hepatitis B. World J Gastroenterol. 2010 Dec 28;16(48):6145-50. doi: 10.3748/wjg.v16.i48.6145.

    PubMed 21182232

  • Marcellin P, Bonino F, Yurdaydin C, Hadziyannis S, Moucari R, Kapprell HP, Rothe V, Popescu M, Brunetto MR. Hepatitis B surface antigen levels: association with 5-year response to peginterferon alfa-2a in hepatitis B e-antigen-negative patients. Hepatol Int. 2013 Mar;7(1):88-97. doi: 10.1007/s12072-012-9343-x. Epub 2012 Mar 23.

    PubMed 23518903

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing PegIFN alfa-2a in people with Chronic Hepatitis B, run by Huashan Hospital at 19 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 3 inclusion and 16 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 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 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?

Number of participants who relapse (time frame: 96 weeks). 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 NCT02594293, which also lists 18 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 31 Oct 2022.

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