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Chronic Hepatitis BPhase 3NCT04846491

A Study of Peginterferon Alfa-2b Combined With TDF in Patients With Chronic Hepatitis B

A Phase 3 study testing Peginterferon alfa-2b injection and TDF in people with Chronic Hepatitis B, run by Xiamen Amoytop Biotech Co., Ltd. at 33 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

Current clinical practices has shown promising prospects of the therapy strategy of interferon combined with nucleos(t)ides in patients with chronic hepatitis B, but the safety and efficacy has not been fully studied. 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?
Peginterferon alfa-2b injection and TDF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
475 participants
Where
33 sitesChina
Study dates
4 Dec 2019to 7 Dec 2023
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

  • Understand and sign the informed consent form voluntarily.
  • Age between 18 and 65 years (including 18 and 65), no gender limit.
  • HBsAg-positive for at least 6 months or other evidence supporting chronic infection with hepatitis B virus.
  • HBsAg positive at screening.
  • For NAs treated patients: Who should have continuously taken NAs for at least 9 months prior to screening, and are currently receiving the NAs. Simultaneously, the patients should have achieved the following criteria: HBsAg<1500IU/mL, HBV DNA<100IU/ml, HBeAg<10s/co at screening.
  • For treatment naive patients: HBV DNA≥1×10^4IU/ml, and 2×ULN (upper limit of normal) ≤ALT≤10×ULN at screening.
  • Pregnancy test of female of childbearing must be negative within 24 hours before the first medication, and the subjects (male and female) should take effective contraceptive measures during the whole study period.

Who cannot join

  • Women who are pregnant, breastfeeding or planning to pregnant during the study period.
  • Subjects with neuropsychiatric diseases and/or neuropsychiatric family history, especially depression, anxiety, or mania schizophrenia.
  • Co-infected with Hepatitis A, Hepatitis C, Hepatitis D, Hepatitis E, or HIV.
  • Chronic hepatitis other than hepatitis B, e.g. alcoholic hepatitis, drugs-induced hepatitis, or autoimmune hepatitis, etc.
  • Moderate to severe steatohepatitis.
  • Evidence of acute severe hepatitis, e.g. ALT>10×ULN, significantly increasing in ALT accompanied by elevated bilirubin, etc.
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  • Evidence of liver decompensation, e.g. total bilirubin higher than 2×ULN, albumin lower than 35g/L, prothrombin time is 3 seconds longer than the upper limit of normal, prothrombin activity lower than 60%, or history of decompensated liver cirrhosis, etc.
  • Evidence of hepatocellular carcinoma, or AFP>1×ULN.
  • Significant kidney diseases, including acute nephritis, chronic nephritis, renal insufficiency, nephrotic syndrome, etc. or serum creatinine higher than upper limit of normal.
  • Neutrophil count less than 1.5×10^9/L, or platelet count less than 90×10^9/L at screening.
  • Serum phosphorus lower than 0.8mmol/L.
  • Antinuclear antibody (ANA) exceeds 1:100.
  • Autoimmune disease, including psoriasis, systemic lupus erythematosus, etc.
  • Subjects with endocrine system disease, including thyroid, Diabetes mellitus, etc.
  • Poorly controlled hypertension (blood pressure ≥140/90 mmHg).
  • Subjects with severe heart disease, especially those with unstable angina or poorly controlled heart disease within 6 months prior to screening.
  • Severe retinopathy or any other severe diseases in the eyes.
  • Subject who had ever received organ transplants or are planning to receive organ transplant.
  • For NAs-treated patients: who have received standard treatment of interferon products within 6 months prior to screening .
  • For treatment naive patients: who have ever received standard treatment of interferon products, or who have ever received NAs within 6 months prior to screening.
  • Subject who are allergic to interferon, tenofovir, or any excipients, or meet any of the contraindications described in the drug instructions.
  • Subjects who participated in any other interventional trials within 3 months prior to screening, or with any other conditions which in the opinion of the investigator precluding enrollment from the study.

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

China33 sites

  • Beijing Ditan Hospital, Capital Medical University

    Beijing

  • Beijing Youan Hospital, Capital Medical University

    Beijing

  • Peking University First Hospital

    Beijing

  • The fifth medical center of PLA General Hospital

    Beijing

  • The Second Xiangya Hospital of Central South University

    Changsha

  • Xiangya Hospital Central South University

    Changsha

  • Public Health Clinical Center of Chengdu

    Chengdu

  • Sichuan Provincial People's Hospital

    Chengdu

  • Mengchao Hepatobiliary Hosipital of Fujian Medical University

    Fuzhou

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou

  • The Ninth Hospital of the Joint Logistic Support Force of the Chinese People's Liberation Army

    Fuzhou

  • Guangzhou Eighth People's Hospital

    Guangzhou

  • The Third Affiliated Hospital,SUN YAT-SEN University

    Guangzhou

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin

  • The First Affiliated Hospital of Anhui Medical University

    Hefei

  • Nanjing Drum Tower Hospital/The First Affiliated Hospital of Nanjing University Medical School

    Nanjing

  • Huashan Hospital affiliated to Fudan University

    Shanghai

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai

  • The Sixth People's Hospital of Shenyang

    Shenyang

  • Peiking University Shenzhen Hospital

    Shenzhen

  • The Third People's Hospital of shenzhen

    Shenzhen

  • The First Hospital of Shanxi Medical University

    Taiyuan

  • First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

    Tianjin

  • Tianjin Third Central Hospital

    Tianjin

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi

  • Traditional Chinese Medicine hospital of Xinjiang Uygur Autonomous Region

    Ürümqi

  • Tongji Hospital/Tongji Medical College Huazhong University of Science & Technology

    Wuhan

  • Tangdu Hospital

    Xi'an

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an

  • The First Affiliated Hospital of Xiamen University

    Xiamen

  • Xiamen Hospital of Traditional Chinese Medicine

    Xiamen

  • Yanbian University Hospital/Yanbian Hospital

    Yanbian

  • Henan Provincial People's Hospital

    Zhengzhou

Other trials in China

About this study

Official title: A Multi-center, Randomized, Blinded Study to Evaluate the Efficacy and Safety of Peginterferon Alfa-2b Injection Combined With Tenofovir Disoproxil Fumarate Tablets in Patients With Chronic Hepatitis B

Current clinical practices has shown promising prospects of the therapy strategy of interferon combined with nucleos(t)ides in patients with chronic hepatitis B, but the safety and efficacy has not been fully studied. This study is aimed to exploit the safety and efficacy of the study drug, Peginterferon alfa-2b injection, with nucleos(t)ide (NAs), tenofovir disoproxil fumarate tablets (TDF), in the patients with hepatitis B, who has previously treated with nucleos(t)ides and who are treatment naïve.

Being tested
Peginterferon alfa-2b injection, TDF
Keywords
peginterferon alfa-2b injection, interferon alfa, nucleos(t)ide, NUCs, NAs, 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.

  • Peginterferon alfa-2b injectionDrug

    Peginterferon alfa-2b injection (high dose) will be weekly subcutaneous injected for 8 weeks and then stop for 4 weeks, 12 week a cycle, up to 12 cycles (144 weeks) at most. TDF will be taken orally during the whole treatment period. And then followed for 24 weeks after treatment.

  • Peginterferon alfa-2b injectionDrug

    Peginterferon alfa-2b injection (low dose) will be weekly subcutaneous injected for 8 weeks and then stop for 4 weeks, 12 week a cycle, up to 12 cycles (144 weeks) at most. TDF will be taken orally during the whole treatment period. And then followed for 24 weeks after treatment.

  • TDFDrug

    Patients will take TDF orally for the first 48 weeks, and then one can choose to continue the single-TDF treatment up to 144 weeks, or may choose to change to receive peginterferon alfa-2b combined TDF therapy for the later 96 weeks, peginterferon alfa-2b will be weekly subcutaneous injected for 8 weeks and then stop for 4 weeks, 12 weeks a cycle. And then followed for 24 weeks after treatment.

  • Peginterferon alfa-2b injectionDrug

    Peginterferon alfa-2b injection will be weekly subcutaneous injected for 8 weeks and then stop for 4 weeks, 12 week a cycle, up to 12 cycles (144 weeks) at most. TDF will be taken orally during the whole treatment period. And then followed for 24 weeks after treatment.

Study groups in NCT04846491
Study groupRoleWhat they receive
Nucleot(s)ide-treated patients-Experimental Group 1ExperimentalNot described
Receives: Drug: Peginterferon alfa-2b injection
Nucleot(s)ide-treated patients-Experimental Group 2ExperimentalNot described
Receives: Drug: Peginterferon alfa-2b injection
Nucleot(s)ide-treated patients-Control GroupActive comparatorNot described
Receives: Drug: TDF
Treatment Naive GroupOtherNot described
Receives: Drug: Peginterferon alfa-2b injection

What is being measured

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

  1. Proportion of patients with HBsAg negative.

    Measured: 24 weeks post treatment.

Secondary outcomes (10)

  1. Changes of HBsAg level from baseline.

    Measured: up to 168 weeks.

  2. Proportion of patients with HBsAg seroconversion.

    Measured: up to 168 weeks.

  3. Proportion of patients with HBeAg negative.

    Measured: up to 168 weeks

  4. Proportion of patients with HBeAg seroconversion.

    Measured: up to 168 weeks.

  5. Changes of HBeAg level from baseline.

    Measured: up to 168 weeks.

  6. Proportion of patients with HBV DNA undetectable.

    Measured: up to 168 weeks.

  7. Changes of HBV DNA level from baseline.

    Measured: up to 168 weeks.

  8. Proportion of patients with ALT normalization.

    Measured: up to 168 weeks.

  9. Proportion of patients with liver fibrosis.

    Measured: up to 168 weeks.

  10. Proportion of patients with liver cirrhosis.

    Measured: up to 168 weeks.

Timeline

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

  1. First posted15 Apr 2021
  2. Study start4 Dec 2019
  3. Primary completion30 Nov 2023
  4. Study completion7 Dec 2023

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
475 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04846491
Sponsor's protocol ID
TB1901IFN
Status last verified
Aug 2023
First submitted
12 Apr 2021
Last updated
5 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Peginterferon alfa-2b injection and TDF in people with Chronic Hepatitis B, run by Xiamen Amoytop Biotech Co., Ltd. at 33 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 7 inclusion and 22 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 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 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 HBsAg negative. (time frame: 24 weeks post 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 NCT04846491.

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 5 Mar 2024.

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