Addition of PegIFN Alfa-2a to CHB Patients Treated With Nucleot(s)Ides

NCT02644538 | Unknown Phase 4 DMC

• 1 other identifier: APACE
• Study Type: interventional
• Target: 196
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates whether PegIFN alfa-2a add on can improve CHB patients HBsAg clearance at the end of 48 weeks treatment. The CHB patients who received nucleot(s)ides anti-virus treatment and reached HBV DNA\<1000 copies/ml and HBsAg\<3000 IU/ml, were randomly assigned into two groups: One group continue the nucleot(s)ides treatment for 72 weeks, the other add on PegIFN alfa-2a on the basis of the original treatment for 48 weeks, and follow up for 24 weeks.

Conditions

Hepatitis B

Keywords

HBsAg clearance

Outcome Measures

Primary Outcomes (1)

• Number of participants who achieve HBsAg clearance

  To investigate whether Peg-IFN alfa-2a add on treatment can improve the HBsAg clearance in CHB patients at the end of the treatment (48 week).

  treat for 48 weeks

Secondary Outcomes (4)

• Number of participants who achieve HBsAg seroconversion

  48 weeks

• Number of participants who achieve HBeAg clearance and seroconversion

  48 weeks

• HBsAg changes from Baseline

  12,24 and 48 weeks

• Number of participants who achieve HBV DNA<1000 copies/ml

  12,24 and 48 weeks

Study Arms (2)

nucleot(s)ides treated

NO INTERVENTION

patients who treated with nucleot(s)ides (including lamivudine, adefovir, entecavir, tenofovir) are still using the original treatment for 72 weeks

PegIFN alfa-2a + nucleot(s)ides treated

ACTIVE COMPARATOR

patients who treated with nucleot(s)ides (including lamivudine, adefovir, entecavir, tenofovir), then will add PegIFN alfa-2a to the original nucleot(s)ides for 48 weeks, then follow up for 24 weeks

Drug: PegIFN alfa-2a

Interventions

PegIFN alfa-2a DRUG

chronic hepatitis B patients who treated with nucleot(s)ides (including lamivudine, adefovir, entecavir, tenofovir) arrived HBV DNA \<1000copies/ml, and HBsAg\<3000IU/ml, then change the treatment to original nucleot(s)ides add on PegIFN alfa-2a, the combined treatment is for 48 weeks, and follow up for 24 weeks

Also known as: Pegasys

PegIFN alfa-2a + nucleot(s)ides treated

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects,18-65 years
• positive for hepatitis B surface antigen (HBsAg) and negative for antibodies to HBsAg (anti-HBs antibodies) for at least 6 months before NAs treated
• nucleot(s)ides monotherapy (including lamivudine, adefovir, entecavir, tenofovir) and achieved HBV DNA\<1000 copies/mL with HBsAg \<3000 IU/mL, positive or negative for HBeAg, and negative for anti-HBs antibodies
• Subjects with no contra-indications to Peginterferon alfa therapy as detailed in the label (Hypersensitivity to the active substance, to alpha interferon, or to any of the excipients; Autoimmune hepatitis; Severe hepatic dysfunction or decompensated cirrhosis of the liver; A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months)
• Subjects who are not co-infected with Hepatitis A Virus, Hepatitis C Virus or HIV
• Female subjects not pregnant or breast feeding when Peginterferon alfa treatment commenced, and aware of the requirement to use an effective method of contraception during therapy
• Written informed consent signed.

You may not qualify if:

• positive for Hepatitis A Virus Ab, HCV-RNA or positive for Hepatitis C Virus Ab, HDV Ab, HEV Ab or positive for HIV Ab in screening period
• 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
• Compensated or Decompensated liver cirrhosis: with history of cirrhosis before nucleot(s)ides treatment or Child-Pugh score ≥ 5 or Complications of liver cirrhosis such as ascites, hepatic encephalopathy, esophageal gastric varices bleeding
• Autoimmune disease including Autoimmune hepatitis and Psoriasis and so on
• Pregnant women and lactating women or patients with pregnancy plans and not willing to use contraception during the study period
• A history of immunoregulation drug therapy within one year before entry including IFN and so on
• Have a history of alcohol abuse
• With severe psychiatric condition or nervous disease such as epilepsy, depression, mania, epilepsy, schizophrenia and so on
• A neutrophil count of less than 1500 per cubic millimeter or a platelet count of less than 90,000 per cubic millimeter
• Severe organ dysfunction
• With other malignant tumors(exclude the cured ones)
• Uncontrolled diabetes, hypertension or thyroid disease
• A serum creatinine level that was more than 1.5 times the upper limit of the normal range
• Hypersensitivity to interferon(IFN) or its active substance, and ineligible to IFN
• Participate in other clinical studies at the same time

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead
• People's Hospital of Anshun City of Guizhou Province: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator

Related Publications (9)

• 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.

  PMID: 15014185 RESULT

• 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.

  PMID: 19729084 RESULT

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

  PMID: 19187608 RESULT

• 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.

  PMID: 22436845 RESULT

• 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.

  PMID: 23046671 RESULT

• 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.

  PMID: 21182232 RESULT

• 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.

  PMID: 23518903 RESULT

• Piratvisuth T, Marcellin P, Popescu M, Kapprell HP, Rothe V, Lu ZM. Hepatitis B surface antigen: association with sustained response to peginterferon alfa-2a in hepatitis B e antigen-positive patients. Hepatol Int. 2013 Jun;7(2):429-36. doi: 10.1007/s12072-011-9280-0. Epub 2011 Jun 24.

  PMID: 21701902 RESULT

• 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.

  PMID: 24915612 RESULT

MeSH Terms

Conditions

Hepatitis B

Interventions

peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of infection disease

Study Record Dates

• First Submitted: December 28, 2015
• First Posted: January 1, 2016
• Study Start: December 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: January 1, 2016

Record last verified: 2015-12