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Chronic Hepatitis B Virus InfectionPhase 3NCT06544551

Efficacy and Safety Study of Peginterferon Alfacon-2 to Treat Chronic Hepatitis B Virus Infection

A Phase 3 study testing Peginterferon Alfacon-2 in people with Chronic Hepatitis B Virus Infection, run by Beijing Kawin Technology Share-Holding Co., Ltd. at 34 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 60 years
Conditions the study is for
Chronic Hepatitis B Virus Infection
What is being tested?
Peginterferon Alfacon-2
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
336 participants
Where
34 sitesChina
Study dates
28 Dec 2021to 30 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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age between 18 and 65 years (including 18 and 60), no gender limit.
  • BMI between 18 and 30 kg/m2 (including 18 and 30).
  • For treatment naive patients: Did not receive standard anti-HBV treatment within 6 months prior to screening (Including interferon, NAs, and other anti-HBV drugs).
  • For NAs treated patients: Who should have continuously taken NAs for at least 9 months prior to screening, and are currently receiving the NAs.
  • HBsAg positive for at least 6 months and HBsAg between 10 and 1000 IU/mL (excluding 10 and 1000).
  • HBsAb and HBeAg both are negative at screening.
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  • For treatment naive patients: HBV DNA < 2×10^3 IU/mL at screening.
  • For NAs treated patients: HBV DNA < 100 IU/mL at screening.
  • For treatment naive patients: ALT ≤ 5ULN at screening.
  • For NAs treated patients: ALT ≤ 2ULN at screening.
  • Liver stiffness measurement <8.0 kPa at screening.
  • Pregnancy test of female of childbearing must be negative at screening, and the subjects (male and female) should take effective contraceptive measures during the whole study period.
  • Understand and sign the informed consent form voluntarily.

Who cannot join

  • For NAs treated patients: who have received standard treatment of interferon products within 6 months prior to screening.
  • Systemic therapy with potent immunomodulatory agents such as adrenocorticotropic hormone, thymosin α1, etc more than two weeks within past 6 months, not including corticosteroid nasal sprays, inhaled steroids and / or topical steroids.
  • Co-infected with Hepatitis A, Hepatitis C, Hepatitis D, Hepatitis E, or HIV.
  • Evidence of liver compensation, including previous liver biopsy, imaging examination or clinical manifestations.
  • Evidences of hepatic decompensation, including but not limited to serum total bilirubin> 2 times the upper limit of normal (ULN); serum albumin <35g/L; prothrombin activity (PTA) <60%; ascites, upper gastrointestinal bleeding and hepatic encephalopathy; Child-Pugh score B/C grade.
  • Evidence of hepatocellular carcinoma, or AFP>>50 ng/mL, or imaging examination revealed suspicious nodules in the liver.
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  • Liver diseases from other causes, including alcoholic liver disease, non-alcoholic steatohepatitis, drug-induced hepatitis, autoimmune hepatitis (antinuclear antibody titer higher than 1:100), hepatolenticular degeneration (Wilson's disease) and hemochromatosis, etc.
  • White blood cell count <3×10^9/L; neutrophil count<1.5×10^9/L; platelet count<90×10^9/L; hemoglobin below the lower limit of normal; serum creatine kinase (CK) >3×ULN; blood phosphorus <0.8 mmol/L; serum creatinine (SCr) > 1×ULN.
  • Diabetes mellitus or Poorly controlled Thyroid Diseases.
  • Poorly controlled hypertension (systolic blood pressure> 140mmHg, or diastolic blood pressure> 90 mmHg) with hypertension -related retinal lesions.
  • Immunodeficiency or autoimmune diseases including but not limited to inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, scleroderma, Sjogren's syndrome, autoimmune thrombocytopenia, etc.
  • Psychiatric and nervous system disorders, including history of psychiatric illness or with family history (especially depression, depressive tendencies, epilepsy and hysteria, etc.)
  • Severe cardiovascular diseases (New York Heart Association functional class (NYHA) Ⅲ level and above, myocardial infarction occurred within past 6 months or PTCA performed within past 6 months, unstable angina, uncontrolled arrhythmias).
  • Serious blood disorders (all kinds of anemia, hemophilia, etc.)
  • Severe kidney disease (chronic kidney disease, renal insufficiency, etc.)
  • Serious digestive diseases (gastrointestinal ulcers, colitis, etc.)
  • Severe respiratory disease (pneumonia, chronic obstructive pulmonary disease, interstitial lung disease, etc.)
  • Retinal disease (retinal exfoliation, macular hole, retinal tumors, etc.)
  • Malignancies.
  • Function organs transplant.
  • Allergies or severe allergies, especially allergic to study drugs or any ingredients of the study drugs.
  • Evidence of alcohol or drug abuse (average alcohol consumption male> 40g / day, female> 20g / day).
  • Women who are pregnant or lactating or to be pregnant during the study period.
  • Participated in other clinical trials 3 months prior to the screening.
  • Unwilling to sign the informed consent and adhere to treatment requirements.
  • Other conditions not suitable for study judged by investigators.

Trial locations and contacts

34 sites in 1 country.

34 sites in 1 country

China34 sites

  • Beijing Ditan Hospital, Capital Medical University

    Beijing

  • Beijing Youan Hospital, Capital Medical University

    Beijing

  • Peking university Peoole's hospital

    Beijing

  • The First Hospital of Jilin University

    Changchun

  • The second xiangya hospital of central south university

    Changsha

  • Xiangya Hospital Central South University

    Changsha

  • Sichuan Provincial People's Hospital

    Chengdu

  • The Peoole's hospital of Chizhou

    Chizhou

  • The First Affiliated Hospital of Army Medical University

    Chongqing

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing

  • Mengchao hepatobiliary hospital of Fujian medical university

    Fuzhou

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou

  • Guangzhou Eighth People's Hospital

    Guangzhou

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin

  • Heze Municipal Hospital

    Heze

  • Shandong Public Health Clinical Center

    Jinan

  • Hebei petro china central hospital

    Langfang

  • The First Affiliated Hospital of Nanchang University

    Nanchang

  • The Second Hospital of Nanjing

    Nanjing

  • Pingxiang NO.2 People's Hospital

    Pingxiang

  • Qingdao Municipal Hospital

    Qingdao

  • The Peoole's hospital of Qingyuan

    Qingyuan

  • The Sixth People's Hospital of Shenyang

    Shenyang

  • Shijiazhuang Hospital of Traditional Chinese Medicine

    Shijiazhuang

  • The Third Hospital of Hebei Medical University

    Shijiazhuang

  • The Second People's Hospital of Tianjin

    Tianjin

  • Tianjin Third Central Hospital

    Tianjin

  • Tongji medical college of Hust

    Wuhan

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

    Wuhan

  • The Second Affiliated Hospital of Xian Jiaotong University

    Xi'an

  • The third affiliated hospital of Xingxiang medical university

    Xingxiang

  • Yanbian University Hospital

    Yanbian

  • Henan People's Hospital

    Zhengzhou

  • The Sixth People's Hospital of Zhengzhou

    Zhengzhou

Other trials in China

About this study

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 Alfacon-2 injection, with nucleos(t)ide (NAs), Tenofovir alafenamide Fumarate Tablets (TAF), in the patients with hepatitis B virus infection.

Being tested
Peginterferon Alfacon-2, Peginterferon Alfacon-2 placebo
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 Alfacon-2Drug

    Peginterferon Alfacon-2 injection will be weekly subcutaneous injected for 48 weeks. Tenofovir alafenamide Fumarate Tablets(TAF) will be take orally for at least 48 weeks, not more than 72 weeks. Peg-interferon Alfacon-2 and TAF will discontinue when HBsAg levels is less than 0.05 IU/mL and HBV DNA is below 10 IU/mL during 48-72 weeks.

  • Peginterferon Alfacon-2 placeboDrug

    Peginterferon Alfacon-2 placebo injection will be weekly subcutaneous injected for 48 weeks. Tenofovir alafenamide Fumarate Tablets(TAF) will be take orally for at least 48 weeks, not more than 72 weeks. Peg-interferon Alfacon-2 and TAF will discontinue when HBsAg levels is less than 0.05 IU/mL and HBV DNA is below 10 IU/mL during 48-72 weeks.

Study groups in NCT06544551
Study groupRoleWhat they receive
Peginterferon Alfacon-2 treated patientsExperimentalNot described
Receives: Drug: Peginterferon Alfacon-2
Peginterferon Alfacon-2 placebo treated patientsPlacebo comparatorNot described
Receives: Drug: Peginterferon Alfacon-2 placebo

What is being measured

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

  1. Proportion of patients with HBsAg negative.

    Percentage of Participants with HBsAg <0.05 IU/mL

    Measured: 72 weeks

Timeline

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

  1. First posted9 Aug 2024
  2. Study start28 Dec 2021
  3. Primary completion30 Nov 2023
  4. Study completion30 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
336 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06544551
Sponsor's protocol ID
Kawin-2021-001
Status last verified
Aug 2024
First submitted
30 Jul 2024
Last updated
9 Aug 2024
Results posted
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 Alfacon-2 in people with Chronic Hepatitis B Virus Infection, run by Beijing Kawin Technology Share-Holding Co., Ltd. at 34 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 13 inclusion and 26 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 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 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. Some participants in this study may receive a placebo. 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: 72 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 NCT06544551.

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 9 Aug 2024.

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