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Chronic Hepatitis bPhase 4NCT03253250

The Investigation of Peginterferon Alfa-2a on the RFS of the Subjects With HCC Who Have Been Treated by Resection

A Phase 4 study testing ETV；TDF；ADV and Peginterferon Alfa-2a in people with Chronic Hepatitis b and Hepatic Carcinoma, run by Huashan Hospital at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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 current study is to investigate whether the Recurrence-free Survival Rate (RFS）of the hepatitis B related -hepatocellular carcinoma subjects who have been treated by resection can be improved by peginterferon alfa-2a Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Chronic Hepatitis b, Hepatic Carcinoma
What is being tested?
ETV；TDF；ADV and Peginterferon Alfa-2a
Could I receive a placebo?
No, everyone receives an active treatment
How many people
432 participants
Where
1 siteChina
Study dates
1 Sep 2017to Dec 2019
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female patients with age ≥18 and ≤70 years;
  • Expected survival time >3 months;
  • There should be evidences that chronic hepatitis B or hepatitis have been positive, hepatitis B virus (HBV) DNA detectable or undetectable, Alanine aminotransferase(ALT)<upper limit of normal (ULN) or ≥ULN；
  • The patients have been treated by resection due to HCC;
  • The characteristic of tumor should be:Barcelona Clinic Liver Cancer(BCLC): 0,A,B
  • Child-Pugh scores:A
  • Agree to participate in the study and sign the patient informed consent form.

Who cannot join

  • Patients that have been treated by live transplantation、chemoembolization、radiotherapy、chemotherapy、molecular targeted therapy and biotherapy before the resection;
  • Patients that are treated by hepatotoxicity drugs 、immunosuppressant or adjuvant chemotherapy after the resection;
  • Patients who be treated by transcatheter arterial chemoembolization(TACE) after resection;
  • BCLC(Barcelona Clinic Liver Cancer):C、D before the resection;
  • History or other evidence of malignant tumor: except by basal cell carcinoma or squamous cell carcinoma which are cured 、carcinoma in situs of cervix
  • Allergic history to interferon;
Show all 19Show fewer
  • Co-infection with active hepatitis A, hepatitis C, hepatitis D and/or human immunodeficiency virus (HIV);
  • 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);
  • absolute neutrophil count(ANC)<1.5x 10^9/L or platelet count(PLT)<70x 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 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);
  • 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;
  • Evidence of postoperative complications: infectious、bleeding, etc,. at baseline; or evidence of recurrence or metastasis at baseline;
  • Child-Pugh scores :B、C
  • Patients included in another trial or having been given investigational drugs within 12 weeks prior to screening;
  • Other disease should exclusive considered by the investigator.

Trial locations and contacts

1 site in 1 country.

Lunxiu Qin contact

52887172

qinlx@fudan.edu.cn

Huliang Jia contact

jbl-1@163.com

China1 site, 1 recruiting

  • Huashan Hospital

    Shanghai

    Lunxiu Qin, 52887172, qinlx@fudan.edu.cn

    Huliang Jia, jbl-1@163.com

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Randomized, Multicenter, Open-label, Exploratory Study of Utilizing of Peginterferon Alfa-2a on the Relapse Rate of the Subjects With Hepatocellular Carcinoma Who Have Been Treated by Resection

The current study is a prospective, randomized, open, multi-center investigation. The aim of current study is to investigate whether the Recurrence-free Survival Rate (RFS）of the hepatitis B related -hepatocellular carcinoma subjects who have been treated by resection can be improved by peginterferon alfa-2a

Read the detailed description

The subjects who have been treated by resection due to hepatocellular carcinoma (HCC) will be randomized into 2 groups: the subjects in group A will be treated by Nucleotide analogues (NAs)( ETV, 0.5mg，qd；tenofovir disoproxil fumarate(TDF)，300mg，qd；ADV，10mg，qd）for 96 weeks; the subjects in group B will be treated by peginterferon alfa-2a （135μg/week）combination with NAs (ETV\TDF\ADV)for 96 weeks.

Being tested
ETV；TDF；ADV, Peginterferon Alfa-2a
Medical subject headings
Hepatitis B, Chronic, Carcinoma, Hepatocellular

What participants receive

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

  • ETV；TDF；ADVDrug

    Also called entecavir;tenofovir disoproxil fumarate;adefovir

    NAs

  • Peginterferon Alfa-2aDrug

    Also called pegasys

    peginterferon

Study groups in NCT03253250
Study groupRoleWhat they receive
Group AActive comparatorThe subjects will be treated by NAs (ETV, 0.5mg，qd；TDF，300mg，qd；ADV，10mg，qd）for 96 weeks
Receives: Drug: ETV；TDF；ADV
Group BExperimentalThe subjects will be treated by peginterferon alfa-2a （135μg/week）combination with NAs(ETV\TDF\ADV) for 96 weeks.
Receives: Drug: ETV；TDF；ADV; Drug: Peginterferon Alfa-2a

What is being measured

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

  1. Recurrence-free Survival Rate (RFS）

    Number of subjects without Recurrence in the total subjects

    Measured: 2 years

Secondary outcomes (3)

  1. Recurrence-free Survival Rate (RFS）

    Number of subjects without Recurrence in the total subjects

    Measured: 1 year

  2. Overall Survival Rate (OS）

    Number of subjects with survival in the total subjects

    Measured: 2 years

  3. Overall Survival Rate (OS）

    Number of subjects with survival in the total subjects

    Measured: 1 year

Timeline

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

  1. First posted17 Aug 2017
  2. Study start1 Sep 2017
  3. Primary completionJun 2019 (estimated)
  4. Study completionDec 2019 (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
432 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03253250
Sponsor's protocol ID
PEG-HCC
Status last verified
Sep 2017
First submitted
15 Aug 2017
Last updated
8 Sep 2017
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Sun HC, Tang ZY, Wang L, Qin LX, Ma ZC, Ye QH, Zhang BH, Qian YB, Wu ZQ, Fan J, Zhou XD, Zhou J, Qiu SJ, Shen YF. Postoperative interferon alpha treatment postponed recurrence and improved overall survival in patients after curative resection of HBV-related hepatocellular carcinoma: a randomized clinical trial. J Cancer Res Clin Oncol. 2006 Jul;132(7):458-65. doi: 10.1007/s00432-006-0091-y. Epub 2006 Mar 24.

    PubMed 16557381

  • Sohn W, Paik YH, Kim JM, Kwon CH, Joh JW, Cho JY, Gwak GY, Choi MS, Lee JH, Koh KC, Paik SW, Yoo BC. HBV DNA and HBsAg levels as risk predictors of early and late recurrence after curative resection of HBV-related hepatocellular carcinoma. Ann Surg Oncol. 2014 Jul;21(7):2429-35. doi: 10.1245/s10434-014-3621-x. Epub 2014 Mar 12.

    PubMed 24619495

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ETV；TDF；ADV and Peginterferon Alfa-2a in people with Chronic Hepatitis b and Hepatic Carcinoma, run by Huashan Hospital at 1 site 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 7 inclusion and 19 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 8 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 Lunxiu Qin (52887172, qinlx@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence-free Survival Rate (RFS） (time frame: 2 years). 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 NCT03253250, 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 8 Sep 2017.

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