Skip to content

Effect on functional cure rate of combination therapy of pegylated interferon alfa and Tenofovir alafenamide in patients with treated HBe antigen-negative chronic hepatitis B

Effect on functional cure rate of combination therapy of pegylated interferon alfa and Tenofovir alafenamide in patients with treated HBe antigen-negative chronic hepatitis B

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036100
Enrollment
Unknown
Registered
2020-08-21
Start date
2020-12-01
Completion date
Unknown
Last updated
2020-08-31

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

Conditions

Chronic Hepatitis B

Interventions

A:TAF
B:Peg-IFN a
C:TAF+ Peg-IFN a

Sponsors

Ruijin Hospital North, Shanghai Jiaotong University, School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Male and female patients with age >= 18 and <= 65 years; 2. There should be evidences that HBsAg has been positive for more than 6 months with HBeAg negative after more than one year NAs treatment with HBVDNA negative, HBsAg <= 50000IU/ml and ALT normal 3. Women without ongoing pregnancy or breast feeding and both women and men willing to take an effective contraceptive measure during the treatment.

Exclusion criteria

Exclusion criteria: 1. Allergic history to interferon or NAs; 2. Co-infection with active hepatitis A, hepatitis C, hepatitis D and/or human immunodeficiency virus (HIV); 3. Liver cirrhosis or Child-Pugh scores > 7; 4. History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures, thalassemia); 5. Pregnant or breast-feeding Women; 6. Consuming alcohol in excess of 20g/day for women and 30g/day for men within 12 months prior to enrollment or drug taking history; 7. ANC(absolute neutrophil count) 100ng/ml and/or evidence of hepatocellular carcinoma; 15. Major organ transplantation; 16. Other disease should exclusive considered by the investigator.

Design outcomes

Primary

MeasureTime frame
Number of subjects who achieve HBsAg loss at 96 week;

Secondary

MeasureTime frame
Number of subjects who achieve HBsAg loss at 48 week;The level and decreasion of HBsAg at 48 and72 week;Number of subjects who achieve HBsAg seroconversion;

Countries

China

Contacts

Public ContactXinxin Zhang

Ruijin Hospital North, Shanghai Jiaotong University, School of Medicine

yby89@163.com+86 13817825901

Outcome results

None listed

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