Real World Study About Anti-viral Regimen Adjustment on Achieving Complete Response in CHB Patients

NCT04724785 | Unknown

• 1 other identifier: 2020LCYJ009
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

In the treatment of chronic hepatitis B (CHB), viral suppression is closely related to disease progression, and the lower the viral load, the lower the risk of progression to cirrhosis and hepatocellular carcinoma (HCC). In addition, a considerable number of patients in China are still using non-first-line antiviral therapy, such as adefovir dipivoxil, lamivudine, and telbivudine (ADV/LAM/LdT). About 25% of patients who received entecavir(ETV) treatment for more than half a year and confirmed that their DNA had turned negative by non-high-precision detection methods still had low viremia (LLV,DNA\>20 IU/ml,IU=international unit), and LLV patients were twice as likely to develop HCC as patients with complete viral response.Patients who have received ETV or second-line NA(LAM/ADV/LdT) treatment for more than half a year to 1 year and confirmed HBV-DNA\>10IU/ml by high-precision detection method are recommended to adjust the treatment plan in order to reduce the DNA load below 10IU/ml as soon as possible. It is up to the doctor, in consultation with the patient, to decide whether or not to make the adjustment.

Conditions

Sustained Virologic Response; Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (1)

• The proportion of patients who received a complete virologic response (HBV DNA<10IU/ml) at 24 weeks after therapy adjustment.

  The proportion of patients who received a complete virologic response (HBV DNA\<10IU/ml) at 24 weeks after therapy adjustment.

  24 weeks

Secondary Outcomes (5)

• The proportion of patients with complete virologic response (HBV DNA<10IU/ml) at 12 weeks, 48 weeks and 96 weeks after therapy adjustment.

  12 weeks, 48 weeks ,96 weeks

• he proportion of patients with normal Alanine transaminase（ALT） at baseline and at each follow-up time point

  baseline,12 weeks,48 weeks,96 weeks

• Changes of estimated glomerularfiltrationratee(GFR) compared with baseline at each follow-up time point.

  baseline,12 weeks,48 weeks,96 weeks

• Changes of serum creatinine(SCr）compared with baseline at each follow-up time point.

  baseline,12 weeks,48 weeks,96 weeks

• Changes of bone mass density（BMD) compared with baseline at each follow-up time point.

  baseline,12 weeks,48 weeks,96 weeks

Study Arms (3)

patients with persistant low level HBV DNA (<10 IU/ml)

No further intervention(s) to be administered except for monitoring of HBV DNA viraemia

Other: only monitoring

patients with persistant HBV DNA (>10 IU/ml) but refuse to change the regimen

All patients with CHB receiving ETV or second-line NA(LAM/ADV/LdT) treatment for more than six months to one year will receive HBV-DNA detection, and patients with HBV-DNA≥10 IU/ml will be informed and recommended to adjust the treatment regimen. If those patients refuse to change the regimen which they are using , No further intervention(s) to be administered except for monitoring of HBV DNA viraemia until those patients change their idea

Other: monitoring and regimen change if necessary

patients with persistant HBV DNA (>10 IU/ml) and agree to change the regimen

All patients with CHB receiving ETV or second-line NA(LAM/ADV/LdT) treatment for more than six months to one year will receive HBV-DNA detection, and patients with HBV-DNA≥10 IU/ml will be informed and recommended to adjust the treatment regimen.They will change their regimen according one which they are using.

Drug: regimen change

Interventions

only monitoring OTHER

monitoring the viraemia only

patients with persistant low level HBV DNA (<10 IU/ml)

monitoring and regimen change if necessary OTHER

if those patients agree, the regimen will be changed.

patients with persistant HBV DNA (>10 IU/ml) but refuse to change the regimen

regimen change DRUG

Based on ongoing one, regimen will be changed . The principle for adjusting anti-viral regimen is as follows: 1. The patients were treated with second-line drugs: changing ADV to ETV/TAF/TDF , changing LAM to TAF/TDF and changing LdT to TAF/TDF; 2. The patients were treated with ETV: adding or switching to TAF/TDF;3. TAF or ETV is recommended for patients with one or more TDF risk factors, such as \> 40 years old, patients with abnormal bone/kidney related indicators or patients with high risk of bone/kidney injuries.【ADV=adefovir dipivoxil, LAM=lamivudine, and LdT=telbivudine , TAF =Tenofovir alafenamide Fumarate, ETV=Entecavir and TDF=Tenofovir disoproxil fumarate 】

patients with persistant HBV DNA (>10 IU/ml) and agree to change the regimen

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The research subjects were patients with CHB (chronic hepatitis B) receiving ETV or second-line NA(LAM/ADV/LdT) who were admitted to The Second Affiliated Hospital of Chongqing Medical University and other centers.

You may qualify if:

• any patients treated with ETV\\LAM\\ADF\\LDT\\TDF\\TAF.【ADV=adefovir dipivoxil, LAM=lamivudine, and LdT=telbivudine , TAF =Tenofovir alafenamide Fumarate, ETV=Entecavir and TDF=Tenofovir disoproxil fumarate 】

You may not qualify if:

• with a expected life span \<48 weeks

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The second affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

RECRUITING

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MeSH Terms

Conditions

Hepatitis B, Chronic

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

• DACHUAN CAI, PhD

  The Second Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DACHUAN CAI, Ph D

CONTACT

862362887039; 597521685@qq.com

PENG HU, Ph D

CONTACT

8613608338064; hp_cq@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr/ Prof.

Study Record Dates

• First Submitted: January 17, 2021
• First Posted: January 26, 2021
• Study Start: December 1, 2020
• Primary Completion: July 1, 2022
• Study Completion: December 31, 2022
• Last Updated: August 5, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)