The Effectiveness and Safety of Tenofovir Alafenamide in the Treatment of Chronic Hepatitis B Patients With Mildly Elevated Alanine Aminotransferase and Significant Liver Injury.

NCT04674423 | Unknown Phase 4

• 1 other identifier: AB-CR 108-062
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In Taiwan, non-cirrhosis CHB patients with mildly elevated ALT are not candidates for antiviral treatment under Taiwan NIH reimbursement criteria. Disease severity could range from mildly liver injury to cirrhosis in this group of patients. There is a substantial population of patients required antiviral treatment, but not fulfill the criteria of reimbursement treatment. For the 2 phase 3 trials of TAF, the treatment criteria of ALT were more than 2x of ULN and did not included liver biopsy as a pre-treatment assessment. In this study, CHB patient with ALT level of 1-2x ULN and significant liver injury evaluated by liver biopsy is the target study population.

Conditions

Chronic Hepatitis b

Keywords

Chronic hepatitis B, tenofovir Alafenamide, ALT, liver injury

Outcome Measures

Primary Outcomes (1)

• Liver histological response

  Histological response is defined as an improvement of at least two points in the HAI inflammation score of Knodell necro-inflammation scoring system with no worsening of fibrosis or an improvement of at least one point in the fibrosis score of Metavir scoring system.

  Histological response between baseline and after 144-week TAF Treatment

Secondary Outcomes (1)

• Virology response

  Virological response of 1, 2, 3 years of TAF treatment

Study Arms (2)

TAF Treatment

EXPERIMENTAL

TAF treatment for 144 weeks and followed for 48 weeks after 144-week TAF treatment

Drug: Tenofovir Alafenamide

Observation arm

NO INTERVENTION

Observation for 144 weeks

Interventions

Tenofovir Alafenamide DRUG

Tenofovir Alafenamide treatment for 144 weeks

TAF Treatment

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age more than 20 years
• Presence of HBsAg positivity for more than 6 months that indicated chronic HBV infection;
• HBV viral load more than 20000 IU/mL in HBeAg positive or more than 2000 IU/mL in HBeAg Negative CHB patients;
• Presence of liver injury which was defined as histology activity index (HAI) \>3 by Knodell necroinflammantion scoring system or liver fibrosis stage 2 or stage 3 by Metavir scoring system; Liver histology available for evaluation 6 months before starting screening is also acceptable. This criteria is limited to subjects enrolling TAF treatment group.
• ALT level between 1-2 folds of ULN for at least one occasion in recent 1 year before screening;
• Treatment naïve;

You may not qualify if:

• Other etiology of chronic hepatitis; Those patients with spontaneous clearance of HCV defined as presence of anti-HCV antibody but undetectable of HCV RNA at least 3 months before enrollment and without history of anti-viral treatment could be included.
• Severe comorbid disorders;
• Uncontrolled diabetes mellitus (HBA1c \> 8.5%);
• Current evidence or suspicious of malignancy;
• Diagnosis of liver cirrhosis;
• eGFR \< or = 30 ml/min/1.73m2.
• Any one of following hematology or biochemical or clinical abnormalities:
• Albumin \<3.5g/dL, Total Bilirubin \>2.5mg/dL, prothrombin time prolongation \>4 sec or INR \>1.7, platelet count \<100 x 103 uL, and history or presence of ascites or hepatic encephalopathy.
• Child-bearing age women without the willing to contraceptive control, or lactating or pregnant women.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng-Kung University Hospital

Tainan, 704, Taiwan

RECRUITING

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

Central Study Contacts

Pin-Nan Cheng, MD

CONTACT

886-6-2353535; pncheng@mail.ncku.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Two treatment groups: TAF group and control group Treatment groups: 1. TAF treatment group (144 weeks) 2. Controlled group (144 weeks)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 19, 2020
• Study Start: May 14, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 22, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)