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

Xiamen Amoytop Biotech

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis B

Treatments: Drug: Peginterferon alfa-2b injection; Drug: TDF

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04846491

TB1901IFN

Details and patient eligibility

About

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.

Enrollment: 475 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

475 participants in 4 patient groups

Nucleot(s)ide-treated patients-Experimental Group 1

Experimental group

Treatment:

Drug: Peginterferon alfa-2b injection

Drug: Peginterferon alfa-2b injection

Drug: Peginterferon alfa-2b injection

Nucleot(s)ide-treated patients-Experimental Group 2

Experimental group

Treatment:

Drug: Peginterferon alfa-2b injection

Drug: Peginterferon alfa-2b injection

Drug: Peginterferon alfa-2b injection

Nucleot(s)ide-treated patients-Control Group

Active Comparator group

Treatment:

Drug: TDF

Treatment Naive Group

Other group

Treatment:

Drug: Peginterferon alfa-2b injection

Drug: Peginterferon alfa-2b injection

Drug: Peginterferon alfa-2b injection