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AzTrials

Chronic Hepatitis BPhase 3NCT01760122

Efficacy and Safety of Peginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B

A Phase 3 study testing Ypeginterferon alfa-2b and Pegasys in people with Chronic Hepatitis B, run by Xiamen Amoytop Biotech Co., Ltd. at 43 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 aimed to assess the efficacy and safety of Peginterferon alfa-2b (40kD, Y-shape), in a dose of 180μg/week, in chronic hepatitis B patients, and collects sufficient evidences for the listed of the studied drug. 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?
Ypeginterferon alfa-2b and Pegasys
Could I receive a placebo?
No, everyone receives an active treatment
How many people
820 participants
Where
43 sitesChina
Study dates
Mar 2013to Aug 2015
Phase
Phase 3
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

  • Age: 18~65 years.
  • Serum HBsAg or HBV DNA positive for at least 6 months.
  • Serum HBsAg and HBeAg are both positive, HBV DNA ≥ 20,000IU/ml at screening.
  • 2×ULN≤ ALT ≤10×ULN at screening (ULN=upper limit of normal).
  • Pregnancy tests of female patients must be negative. All patients with effective birth control measures during treatment period and 6 months after the treatment.

Who cannot join

  • Pregnant or lactating women.
  • Mental disorder or physical disability.
  • Interferon treatment history or using nucleos(t)ide analogue for chronic hepatitis B treatment within the previous 6 months.
  • ANC < 1500/mm3, or PLT < 90,000/mm3.
  • Co-infection with HAV, HIV, HCV, HDV, or HEV.
  • Both of HBsAg and anti-HBs are positive, or both of HBeAg and anti-HBe are positive at screening.
Show all 12Show fewer
  • Child-Pugh ≥ B, or other evidence of hepatitis decompensation (e.g.: prothrombin time prolonged more than 3 seconds, TBil > 2ULN, Alb<35g/L).
  • Chronic hepatitis caused by any other reason except hepatitis B.
  • Hepatocarcinoma or suffering from any other malignant tumor.
  • Not well-controlled endocrine diseases (e.g.: thyroid dysfunction, diabetes mellitus)
  • Significant function damage in any major organs (e.g.: heart, lung, kidney).
  • Other Conditions which in the opinion of the investigator precluding enrollment into the study (e.g.: poor compliance).

Trial locations and contacts

43 sites in 1 country.

43 sites in 1 country

China43 sites

  • 302 Military Hospital

    Beijing

  • Beijing Ditan Hospital Capital Medical University

    Beijing

  • Beijing Youan Hospital, Capital Medical University

    Beijing

  • Beijing Youyi Hospital, Capital Medical University

    Beijing

  • Peking University First Hospital

    Beijing

  • Peking University People's Hospital

    Beijing

  • First Affiliated Hospital of Jilin University

    Changchun

  • Xiangya Hospital, Central-south University

    Changsha

  • Xiangya Second Hospital, Central-south University

    Changsha

  • West China Hospital, Sichuan University

    Chengdu

  • Second Affiliated Hospital Chongqing Medical University

    Chongqing

  • Southwest Hospital

    Chongqing

  • Fuzhou Infectious Disease Hospital

    Fuzhou

  • Guangzhou Eighth People's Hospital

    Guangzhou

  • Nanfang Hospital

    Guangzhou

  • First Affiliated Hospital of Guangxi Medical University

    Guilin

  • First Affiliated Hospital, Zhejiang University

    Hangzhou

  • Second Affiliated Hospital of Harbin Medical University

    Harbin

  • Jinan Infectious Disease Hospital

    Jinan

  • First Affiliated Hospital of Lanzhou University

    Lanzhou

  • 81 Military Hospital

    Nanchang

  • First Affiliated Hospital of Nanchang University

    Nanchang

  • Jiangsu Province Hospital

    Nanjing

  • Second Hospital of Nanjing

    Nanjing

  • 85 Military Hospital

    Shanghai

  • Huashan Hospital

    Shanghai

  • Ruijing Hospital

    Shanghai

  • Shanghai Public Health Clinical Center

    Shanghai

  • Shengjing Hospital of China Medical University

    Shenyang

  • Shenyang Sixed People's Hospital

    Shenyang

  • Beijing University Shenzhen Hospital

    Shenzhen, Guangdong, 518036

  • Third Affiliated Hospital, Hebei Medical University

    Shijiazhuang

  • First Affiliated Hospital, Shanxi University

    Taiyuan

  • Tianjin Third Central Hospital

    Tianjin

  • First Affiliated Hospital of Xinjiang Medical University

    Ürümqi

  • First Affiliated Hospital of Wenzhou Medical College

    Wenzhou

  • Tongji Hospital, Huazhong University of Science & Technology

    Wuhan

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan

  • Tangdu Hospital, Fourth Military Medical University

    Xi'an

  • Xijing Hospital

    Xi'an

  • Xiamen Hospital of T.C.M

    Xiamen, Fujian, 361000

  • The First Affiliated Hospital of Xiamen University

    Xiamen

  • Henan Provincial People's Hospital

    Zhengzhou

Other trials in China

About this study

Official title: A Phase 3, Randomized, Multi-center, Active-controlled, Open-label Study to Evaluate the Efficacy and Safety of Peginterferon Alfa-2b (40kD, Y Shape) in Chinese Chronic Hepatitis B Patients.

This study is aimed to assess the efficacy and safety of Peginterferon alfa-2b (40kD, Y-shape), in a dose of 180μg/week, in chronic hepatitis B patients, and collects sufficient evidences for the listed of the studied drug.

Being tested
Ypeginterferon alfa-2b, Pegasys
Keywords
peginterferon, HBeAg Positive, Chronic hepatitis B
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.

  • Ypeginterferon alfa-2bDrug

    sc, qw, 48 weeks.

  • PegasysDrug

    sc, qw, 48 weeks.

Study groups in NCT01760122
Study groupRoleWhat they receive
Ypeginterferon Alfa-2bExperimentalNot described
Receives: Drug: Ypeginterferon alfa-2b
PegasysActive comparatorNot described
Receives: Drug: Pegasys

What is being measured

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

  1. Proportion of patients with HBeAg seroconversion at week72

    Measured: 24 weeks after the cessation of treatment

Secondary outcomes (5)

  1. Proportion of Patients with HBeAg seroconversion at week 12,24,48

    Measured: week 12, 24, 48 from treatment starting

  2. Proportion fo patients with HBeAg undetectable at week 12, 24, 48, and 72.

    Measured: week 4, 12, 24, 48 and 72 from treatment starting

  3. Average of HBV DNA decline level at week 12, 24,48 and 72

    Measured: week 12, 24, 48 and 72 from treatment starting

  4. Average of HBsAg decline level at week 12, 24, 48 and 72, and Proportion of patients with HBsAg undetectable and HBsAg seroconversion at week 12, 24, 48 and 72.

    Measured: week 12, 24, 48 and 72 from treatment starting

  5. Proportion of patients with ALT normalization at week 12,24, 48 and 72.

    Measured: week 12, 24, 48 and 72 from treatment starting

Timeline

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

  1. First posted3 Jan 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionJul 2015
  4. Study completionAug 2015

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
820 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01760122
Sponsor's protocol ID
TB1211IFN
Status last verified
Mar 2015
First submitted
30 Dec 2012
Last updated
31 Aug 2015
Results posted
No
Data monitoring committee
No

Publications

  • Jian W, Yin Y, Chen R, Xue J, Gu J, Du Z, He R, Zhou T. Drug Repositioning of Pegbing(R) for Essential Thrombocythemia: Insights from PK/PD Modeling and Extrapolation. Clin Pharmacol Ther. 2026 Jan;119(1):219-227. doi: 10.1002/cpt.70079. Epub 2025 Oct 6.

    PubMed 41051280

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ypeginterferon alfa-2b and Pegasys in people with Chronic Hepatitis B, run by Xiamen Amoytop Biotech Co., Ltd. at 43 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 5 inclusion and 12 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 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Proportion of patients with HBeAg seroconversion at week72 (time frame: 24 weeks after the cessation of treatment). 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 NCT01760122, which also lists 1 linked publication.

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 Aug 2015.

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