A Perspective Study of the Antiviral Efficacy and Safety of Switching to TAF Treatment in CHB Adults With Suboptimal Response (SOR) and Intolerant to Entecavir

HBV Clinical Trial

Official title:

A Perspective Study of the Antiviral Efficacy and Safety of Switching to TAF Treatment in CHB Adults With Suboptimal Response (SOR) or Intolerant to Entecavir

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04034368
• Other study ID #: ISR-CN-18-10478
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: August 2019
• Est. completion date: June 2021

Study information

• Verified date: July 2019
• Source: First Hospital of Jilin University
• Contact: Yanhang Gao
• Phone: 15804303019
• Email: 15804303019[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, single arm, open label, historical control pilot Study to the antiviral efficacy and safety of Suboptimal Responders to Entecavir Switching to TAF Treatment at week 48 (investigate the rates of complete virological response on switching to TAF in patients with Suboptimal response or ETV intolerance to standard ETV= 0.5 mg monotherapy).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 8
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures;

2. Male and female subjects,18 years of age and older, based on the date of the screening visit;

3. Suboptimal Responders to Entecavir (defined as CHB patients treated with at least 12 months of ETV 0.5mg QD with prior suboptimal response viral load still detectable at week 48).

4. ETV intolerance population (defined as unwilling or poor adherence to administer ETV in fasting food, renal impairment with ETV dosage adjustment required, pts with other unidentified reasons willing to switch, etc);

5. Screening serum ALT level = 10 × ULN;

6. Normal ECG (or if abnormal, determined by the Investigator not to be clinically significant);

7. Must be willing and able to comply with all study requirements.

Exclusion Criteria:

1. Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study;

2. Co-infection with HCV, HIV, or HDV;

3. Any history of, or current evidence of, clinical hepatic decompensation (i.e., moderate-severe ascites, encephalopathy or variceal hemorrhage);

4. Evidence of hepatocellular carcinoma (e.g. as evidenced by recent imaging);

5. Abnormal hematological and biochemical parameters, including: Hemoglobin < 10 g/dl, Absolute neutrophil count < 0.75×109/L, Platelets = 50×109/L, AST or ALT > 10 × ULN, Total bilirubin > 2.5 × ULN, Albumin < 3.0 g/dl, INR > 1.5 × ULN;

6. Received solid organ or bone marrow transplant;

7. Recent history of pancreatitis (within 24 weeks prior to the first dose of study medication);

8. Evidence of other autoimmune or metabolic liver diseases (except non-alcoholic fatty liver disease);

9. Significant renal, cardiovascular, pulmonary, or neurological disease in the opinion of the investigator;

10. Malignancy within the 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection(basal cell skin cancer, etc). Subjects under evaluation for possible malignancy are not eligible;

11. Known hypersensitivity to study drugs, metabolites, or formulation excipients;

12. Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance;

13. Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements.

Related Conditions & MeSH terms

• HBV

Intervention

Drug:
• Tenofovir Alafenamide (TAF)
Tenofovir alafenamide (TAF) 25 mg QD, oral administration, 48 weeks;

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Hospital of Jilin University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Main efficacy endpoint	The primary efficacy endpoint is the proportion of subjects with plasma HBV DNA levels below 20 IU/ml at Week 48.	Week 48
Secondary	Key secondary efficacy endpoint	The proportion of subjects with plasma HBV DNA < 20 IU/mL at Weeks 24	Week 24
Secondary	Key secondary efficacy endpoint	The change from baseline in plasma HBV DNA levels at Weeks 48	Week 48
Secondary	Key secondary efficacy endpoint	The proportion of subjects with ALT normalization at Weeks 24 and 48	Week 24 and Week 48
Secondary	Key secondary efficacy endpoint	The proportion of subjects with HBeAg seroconversion to anti-HBe at Weeks 48	Week 48
Secondary	Key secondary efficacy endpoint	The HBV DNA maintenance rate at week 48 in ETV intolerant pts.	Week 48
Secondary	Key secondary efficacy endpoint	The proportion of subjects with HBsAg seroconversion to anti-HBs at Weeks 48	Week 48
Secondary	Key secondary efficacy endpoint	The incidence of drug resistant mutations at Weeks 48	Week 48