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

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ClinicalTrials.gov Identifier: NCT04724785
Recruitment Status : Recruiting
First Posted : January 26, 2021
Last Update Posted : January 26, 2021
Sponsor:
Information provided by (Responsible Party):
caidachuan, The Second Affiliated Hospital of Chongqing Medical University

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.

Condition or disease Intervention/treatment
Sustained Virologic Response Hepatitis B, Chronic Other: only monitoring Other: monitoring and regimen change if necessary Drug: regimen change

Detailed Description:

In our hospital, about 150 patients are screened for HBV-DNA every day. Therefore, 54 million patients will be tested for HBV-DNA within one year, of which 30% are estimated to be HBV-DNA ≥10 IU. These patients will be informed to the Department of Infectious Diseases of the Second Affiliated Hospital of Chongqing Medical University for follow-up, and will be randomly divided into three groups according to 1:1. Patients in all three groups will be educated about hepatitis B virus infection and antiviral treatment, and the treatment regimen will be adjusted according to whether their HBV DNA is ≥10 IU/ml or not. Patients in group 1: patients with persistant low level HBV DNA (<10 IU/ml). Patients in group 2: HBV-DNA≥10 IU/ml, receiving HBV-related education and being advised by the doctor to change or to add another NA. Patients in group 2: patients with persistant HBV DNA (>10 IU/ml) but refuse to change the regimen. Patients in group 3: patients with persistant HBV DNA (>10 IU/ml) and agree to change the regimen. Educational methods include videos, including an introduction to hepatitis B virus (disease profile, infection, outcome, HBV infection, vertical transmission and other risk factors) for 5 minutes, brochures with relevant information and consultations with physicians and nurses.

All patients with chronic hepatitis B(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 so that the actual prevalence of HBV-DNA load < 10 IU/ml in Chongqing HBV cohort could be obtained . The investigators estimated that 30% of the patients had HBV-DNA≥ 10 IU/ml, so there were about 16,200 patients had HBV-DNA≥ 10 IU/ml among 54,000 patients a year. These patients will be diagnosed with LLV and will undergo a treatment regimen adjustment, with a recommendation to switch to or use a different type of nucleos(t)ide analogue (NA) for anti-viral treatment.

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real World Study on the Effect of HBV-DNA High-precision Detection Based Anti-viral Regimen Adjustment on Achieving Complete Virologic Response in Patients With Chronic Hepatitis B.(REACH)
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
monitoring the viraemia only

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
if those patients agree, the regimen will be changed.

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
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 】




Primary Outcome Measures :
  1. The proportion of patients who received a complete virologic response (HBV DNA<10IU/ml) at 24 weeks after therapy adjustment. [ Time Frame: 24 weeks ]
    The proportion of patients who received a complete virologic response (HBV DNA<10IU/ml) at 24 weeks after therapy adjustment.


Secondary Outcome Measures :
  1. The proportion of patients with complete virologic response (HBV DNA<10IU/ml) at 12 weeks, 48 weeks and 96 weeks after therapy adjustment. [ Time Frame: 12 weeks, 48 weeks ,96 weeks ]
    The proportion of patients with complete virologic response (HBV DNA<10IU/ml) at 12 weeks, 48 weeks and 96 weeks after therapy adjustment.

  2. he proportion of patients with normal Alanine transaminase(ALT) at baseline and at each follow-up time point [ Time Frame: baseline,12 weeks,48 weeks,96 weeks ]
    he proportion of patients with normal Alanine transaminase(ALT )at baseline and at each follow-up time point

  3. Changes of estimated glomerularfiltrationratee(GFR) compared with baseline at each follow-up time point. [ Time Frame: baseline,12 weeks,48 weeks,96 weeks ]
    Changes of estimated glomerularfiltrationratee(GFR) compared with baseline at each follow-up time point.

  4. Changes of serum creatinine(SCr)compared with baseline at each follow-up time point. [ Time Frame: baseline,12 weeks,48 weeks,96 weeks ]
    Changes of serum creatinine(SCr) compared with baseline at each follow-up time point.

  5. Changes of bone mass density(BMD) compared with baseline at each follow-up time point. [ Time Frame: baseline,12 weeks,48 weeks,96 weeks ]
    Changes of bone mass density (BMD) compared with baseline at each follow-up time point.



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Ages Eligible for Study:   14 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 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 】

Exclusion Criteria:

  • with a expected life span <48 weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04724785


Contacts
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Contact: DACHUAN CAI, Ph D 862362887039 597521685@qq.com
Contact: PENG HU, Ph D 8613608338064 hp_cq@163.com

Locations
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China, Chongqing
The second affiliated Hospital of Chongqing Medical University Recruiting
Chongqing, Chongqing, China, 400010
Contact: DACHUAN CAI, PhD    862362887039    597521685@qq.com   
Contact: PENG HU, PhD    8613608338064    hp_cq@163.com   
Principal Investigator: DACHUAN CAI, Professor         
Sponsors and Collaborators
The Second Affiliated Hospital of Chongqing Medical University
Investigators
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Principal Investigator: DACHUAN CAI, PhD The Second Affiliated Hospital of Chongqing Medical University
  Study Documents (Full-Text)

Documents provided by caidachuan, The Second Affiliated Hospital of Chongqing Medical University:
Informed Consent Form  [PDF] May 15, 2020

Publications:

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Responsible Party: caidachuan, Dr/ Prof., The Second Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier: NCT04724785    
Other Study ID Numbers: 2020LCYJ009
First Posted: January 26, 2021    Key Record Dates
Last Update Posted: January 26, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis B, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic