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The study on clinical cure of postpartum pregnant women with Chronic HBV Infection

The study on clinical cure of postpartum pregnant women with Chronic HBV Infection

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400085066
Enrollment
Unknown
Registered
2024-05-30
Start date
2024-06-01
Completion date
Unknown
Last updated
2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

viral hepatitis type B

Interventions

The group of NAs combined Peg-INFa-2b:none
The group of Peg-INFa-2b:none
The group of NAs:none

Sponsors

Xixi Hospital of Hangzhou
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1) Age 18-45, 12-48 weeks after delivery; 2) HBsAg positive and titer = 1500 IU/ml; 3) HBV DNA < 10^3 IU/ml; 4) Voluntary signing of informed consent.

Exclusion criteria

Exclusion criteria: 1) Severe comorbidities during pregnancy, obstetric complications persist during re-follow-up (such as unstable diabetes due to pregnancy and diabetes mellitus, unstable blood pressure due to eclampsia, uncontrolled severe thyroid disease, major postpartum haemorrhage resulting in Seehan syndrome, etc.); 2) Pregnant women or in the near future 3) Combination of A, C, D, hepatitis E, HIV infection and other viral infections; 4) liver tumors: alpha fetoprotein greater than 100 ng/mL, or failure to maintain stability and/or liver imaging within 3 months prior to the trial; 5) In the Liver Loss Period: Liver Histology Tips G/S Score Greater Than 3, Child-Pugh =5 Meets the Following One: 1 Serum albumin 34umol/L; 4 has a history of hepatic encephalopathy; 5 have a history of esophageal varicose vein bleeding; 6 ascites; 6) Immuno-mediated diseases such as inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis, and abnormally elevated levels of autoimmune antibodies; 7) Patients with serious diseases such as heart, lung, kidney, brain, blood, and other important organs, or by other evidence of serious disease or any other disease, make the researchers believe that the patient is unfit to participate in the trial: unstable diabetes, hypertension, thyroid disease, history of severe retinopathy or other evidence of retinopathy, severe epilepsy or current use of antiepileptic drugs 8) In interferon therapy group, also need to exclude the following: ? severe psychiatric history or Edinburgh test paper screening has a tendency to postpartum depression;;?creatinine is 1.5 times higher than the normal limit;?neutrophil counts < 1.5 × 10^9 or platelet counts < 90 × 10^9 ;?require postpartum breastfeeding;?For those allergic to a-interferon and its pharmaceutical components, the researchers judged that it was not suitable for application a interferon patients (who did not respond well to interferon applications in the past);?Subjects entered this trial Received other interferon medications within 4 weeks;?History of organ transplantation and existing functional graft (except corneal or hair transplantation) 9) The researchers assessed that it was not suitable for the patients who participated in the study.

Design outcomes

Primary

MeasureTime frame
HBsAg vaginal rate during treatment and follow-up;

Secondary

MeasureTime frame
HBsAg level decreased from treatment baseline after 24, 48 weeks treatment, follow-up 1 year ;The rate of HBsAg seroconversion;The rate of HBeAg seroconversion;The decline of HBV DNA and the rate of below detected;

Countries

China

Contacts

Public ContactSongrong Liu

Xixi Hospital of Hangzhou

Lsr85463990@126.com+86 180 7293 0585

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026