Efficacy and Safety of TAF for 48 Weeks in HBeAg Positive CHB Patients

NCT04864366 | Unknown

• 1 other identifier: TAF-HBeAg-CHB
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 3

Brief Summary

The objective of this clinical study was to observe the changes of HBsAg levels after a sequential 48 weeks-treatment of TAF in ETV experienced CHB patients and to monitor the levels of cytokines such as IFN-λ3, IP-10, IL-12, IL-10, and IL-21.

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

• Change of serum HBsAg at week 48 from baseline.

  evaluate the changes of serum HBsAg level after 48 week-treatment of TAF in TN and ETV experienced CHB patients.

  from baseline to week 48 after TAF treatment

Secondary Outcomes (15)

• Change of serum HBeAg level from baseline.

  from baseline to week 48 after TAF treatment

• Change of serum HBcAb level from baseline.

  from baseline to week 48 after TAF treatment

• propotion of patients who maintened HBV DNA suppression.

  from baseline to week 48 after TAF treatment

• propotion of patients who maintened ALT normalization.

  from baseline to week 48 after TAF treatment

• Change of renal markers - eGFR from baseline.

  from baseline to week 48 after TAF treatment

Study Arms (2)

Treatment naive patients

1. HBV DNA\> 20000 IU/ml 2. ALT\>2×ULN；or ALT\>1×ULN，but liver biopsy showed inflammation greater than or equal to G2, or/and liver fibrosis greater than or equal to S2 3. No treatment with NA or/or αIFN within 1 year

Drug: Tenofovir Alafenamide 25 MG [Vemlidy]

ETV treatment experienced patients

1. ETV treatment for 1 to 2 years before 2. HBsAg\>3000IU/mL 3. HBV DNA\<20IU/mL 4. ALT\<1×ULN 5. No other NA therapy prior to entecavir treatment 6. Patients had a desire to convert to TAF therapy

Drug: Tenofovir Alafenamide 25 MG [Vemlidy]

Interventions

Tenofovir Alafenamide 25 MG [Vemlidy] DRUG

TAF is administered as a 25mg/tablet, taken orally with food once daily, for 48 weeks.

ETV treatment experienced patients; Treatment naive patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HBeAg-positive men, non-pregnant women and non-lactating women (over 18 years of age) who are infected with HBV alone, treatment naïve or only ETV treatment experienced at least 48 weeks. participate will only receive TAF treatment after informed consent.

You may not qualify if:

• Treatment naive patients
• treated with NA or/or αIFN within 1 year
• Pregnant women, lactating women, or women who plan to become pregnant within 2 years
• Co-infection with Hepatitis C, Hepatitis D or HIV;
• Chronic liver diseases with non-HBV etiology (including but not limited to: autoimmune hepatitis, primary biliary cirrhosis, primary cirrhosis cholangitis, hemochromatosis, etc.
• There is evidence of Child-Pugh grade C decompensated liver disease, or moderate to severe ascites, and grade III-IV hepatic encephalopathy
• There are symptoms and signs of hepatocellular carcinoma. If screening for alpha-fetoprotein (AFP) \<50 ng / mL, imaging examination are not required; but if screening for AFP\> 50 ng / mL, imaging examination are required
• current alcohol or drug abuse may affect compliance
• Patients who recieved solid organ or bone marrow transplantation. Liver or kidney transplantation patients can be enrolled
• malignant tumors within 5 years. Patients being evaluated for possible malignant tumors should be excluded
• Study drugs were used within 3 months prior to screening
• Patients who are participating in other clinical trials, or have been treated with the study drugs within 12 weeks before screening
• Inability or unwillingness to provide informed consent or non-compliance with research requirements
• Patients who are unwilling to purchase TAF on their own
• ETV treatment experienced patients

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (3)

Huashan Hospital Affiliated to Fudan University

Shanghai, China

Location

Ruijin Hospital Affiliate to Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

Shanghai Public Health Clinical Center

Shanghai, China

Location

Biospecimen

blood

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

tenofovir alafenamide

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jiming Zhang, M.D.

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician,professor

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 28, 2021
• Study Start: April 30, 2021
• Primary Completion: October 27, 2023
• Study Completion: December 31, 2023
• Last Updated: March 15, 2023

Record last verified: 2023-03

Locations

CN (3)