Chronic Hepatitis bPhase 3NCT04543565
Pradefovir Treatment for the Patients With Chronic Hepatitis B Virus Infections: a Phase3 Study
A Phase 3 study of Chronic Hepatitis b, run by Xi'an Xintong Pharmaceutical Research Co.,Ltd. at 1 site in China.
Trial summary
This is a phase three study to evaluate the safety and efficacy of Pradefovir treatment in chronic hepatitis B patients. Subject will be randomized to Pradefovir group and TDF group at a ratio of 2:1. Treatment duration will be 96w in randomization and followed by 48w in open. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis b
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 900 participants
- Where
- 1 siteChina
- Study dates
- Sep 2020to Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 65 years old, male or female.
- Meets the diagnosis and treatment standards of chronic hepatitis B( HBsAg or HBV DNA positive over 6 months, or diagnosed by liver biopsy.
- For HBeAg positive, HBV DNA equal or over 20000 IU/ml; for HBeAg negative ,HBV DNA equal or over 2000 IU/ml.
- ALT level between 1.2 ULN to 10 UNL.
- Treatment naive or experienced when any nucleos(t)ide analogs or interferons stopped over 6 months.
- Use of effective contraceptive measures if procreative potential exists.
- Written informed consent.
Who cannot join
- Allergic to study drug,metabolite product or excipient.
- Evidence of hepatic decompensation such as Child-Pugh B or C, with previous gastroesophageal variceal haemorrhage, hepatic encephalopathy, ascites
- Suspected or confirmed hepatocellular carcinoma, or AFP>50μg/L.
- Other liver diseases (such as Chronic alcoholic hepatitis, drug-induced hepatitis, autoimmune liver disease).
- Resistant to antiviral drugs (adefovir or tenofovir).
- Concommitant disease of severe heart, blood, respiratory and central nervous system diseases.
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- Chronic kidney diseases, or Ccr<60ml/min at screening.
- Abnormal hematological and biochemical parameters at screening: White blood cell count less than 3.0×109/L，or neutrophil count less than 1.5×109/L，or platelet count less than 80×109/L，or total bilirubin more than 2ULN，or the prolong of PT more than 3s.
- Positive-HCV or positive-HIV.
- Severe bone disease (such as osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, rickets) or multiple fractures.
- History of pancreatitis or malignancy within 5 years (excluding cervical epithelial carcinoma, squamous epithelial carcinoma, or basal cell carcinoma of the skin that was clinically cured within 5 years of diagnosis).
- Plan to receive or have already had an organ transplant.
- Subject with disabilities as prescribed by law (blindness, deafness, deafness, deafness, mental disorders, etc.).
- History of alcohol or drug abuse within the last 1 year.
- Pregnant or lactating women.
- Participated in any clinical trial or taken any IMP (investigational medical product) within 3 months prior to the trial.
- Other cases that could not be enrolled in the judgement of the investigators.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130061
Junqi Niu, Dr., 13756661205, junqiniu@aliyun.com
About this study
Official title: Pradefovir Treatment for the Patients With Chronic Hepatitis B Virus Infections: a Multi-center, Double-Blind, Randomized, Positive Control, Phase3 Study
This is a phase three study to evaluate the safety and efficacy of Pradefovir treatment in chronic hepatitis B patients. Subject will be randomized to Pradefovir group and TDF group at a ratio of 2:1. Treatment duration will be 96w in randomization and followed by 48w in open. The interim analysis will be conducted when all subject completed the first 48-week treatment.
Read the detailed description
this is a randomized, double-blind, positive drug parallel control, multicenter, phase 3 study .Eligible HBeAg-positive or HBeAg-negative chronic hepatitis B patients will be stratified by historical antiviral treatment (untreated or treated) at the time of screening, and then randomly assigned to Pradefovir mesylate tablet group or tenofovir disoproxil fumarate tablet group at a ratio of 2:1. The proportion of subject with compensatory stage of cirrhosis is no more than 20 percentage. Patients will receive a total of 144 weeks of antiviral treatments, and after 96 weeks of double-blind treatment, all subjects will switch to open mesylate Pradefovir tablets for additional 48 weeks. The first 48 weeks are the core period and the followed 96 weeks are the extension period. Statistical analysis was conducted on the efficacy and safety of the whole trial. (After the completion of 48-week visit of the last one subject, the interim analysis will be conducted. The analysts will be unblinded, while the remaining participants will still be blind.
- Conditions
- Chronic Hepatitis b
- Being tested
- Pradefovir Mesylate;Placebo of Tenofovir disoproxil fumarate tablet, Tenofovir disoproxil fumarate tablet;Placebo of Pradefovir Mesylate
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pradefovir Mesylate;Placebo of Tenofovir disoproxil fumarate tabletDrug
Once daily
Tenofovir disoproxil fumarate tablet;Placebo of Pradefovir MesylateDrug
Once daily
| Study group | Role | What they receive |
|---|---|---|
| Trial group | Experimental | subject in this group will receive Pradefovir mesylate tablet and the placebo of tenofovir disoproxil fumarate tablet, once daily for 96 weeks Receives: Drug: Pradefovir Mesylate;Placebo of Tenofovir disoproxil fumarate tablet |
| Control group | Active comparator | subject in this group will receive tenofovir disoproxil fumarate tablet and the placebo of Pradefovir mesylate tablet, once daily for 96 weeks. Receives: Drug: Tenofovir disoproxil fumarate tablet;Placebo of Pradefovir Mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBV viral suppression
proportion of patients with hepatitis B virus(HBV) -DNA undetectable(<29IU/ml)
Measured: After 48-week therapy
Secondary outcomes (4)
HBV viral suppression
proportion of patients with hepatitis B virus(HBV) -DNA undetectable(<29IU/ml)
Measured: After therapy of 4, 8, 12, 24, 36, 72, 96, 144 weeks
HBV viral suppression
proportion of patients with hepatitis B virus(HBV) -DNA undetectable(<20IU/ml)
Measured: After therapy of 4, 8, 12, 24, 48, 36, 72, 96, 144 weeks
The reduction of HBV DNA load
the change of HBV DNA load from baseline
Measured: at week 4, 8, 12, 24, 36, 48, 72, 96, 144
ALT normalization
proportion of patients with ALT normalization
Measured: After therapy of 4, 8, 12, 24, 48, 36, 72, 96, 144 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study startSep 2020 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis bStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xi'an Xintong Pharmaceutical Research Co.,Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junqi Niu, Dr., Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543565
- Sponsor's protocol ID
- BOJI201939F
- Status last verified
- Sep 2020
- First submitted
- 2 Sep 2020
- Last updated
- 10 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pradefovir Treatment for the Patients With Chronic Hepatitis B Virus Infections: a Multi-center, Double-Blind, Randomized, Positive Control, Phase3 Study
- ClinicalTrials.gov ID
- NCT04543565
- Acronym / sponsor ID
- BOJI201939F
- Conditions
- Chronic Hepatitis b
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Xi'an Xintong Pharmaceutical Research Co.,Ltd.University, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase three study to evaluate the safety and efficacy of Pradefovir treatment in chronic hepatitis B patients. Subject will be randomized to Pradefovir group and TDF group at a ratio of 2:1. Treatment duration will be 96w in randomization and followed by 48w in open. The interim analysis will be conducted when all subject completed the first 48-week treatment.
Detailed description
this is a randomized, double-blind, positive drug parallel control, multicenter, phase 3 study .Eligible HBeAg-positive or HBeAg-negative chronic hepatitis B patients will be stratified by historical antiviral treatment (untreated or treated) at the time of screening, and then randomly assigned to Pradefovir mesylate tablet group or tenofovir disoproxil fumarate tablet group at a ratio of 2:1. The proportion of subject with compensatory stage of cirrhosis is no more than 20 percentage. Patients will receive a total of 144 weeks of antiviral treatments, and after 96 weeks of double-blind treatment, all subjects will switch to open mesylate Pradefovir tablets for additional 48 weeks. The first 48 weeks are the core period and the followed 96 weeks are the extension period. Statistical analysis was conducted on the efficacy and safety of the whole trial. (After the completion of 48-week visit of the last one subject, the interim analysis will be conducted. The analysts will be unblinded, while the remaining participants will still be blind.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trial group | Experimental | Drug: Pradefovir Mesylate;Placebo of Tenofovir disoproxil fumarate tabletsubject in this group will receive Pradefovir mesylate tablet and the placebo of tenofovir disoproxil fumarate tablet, once daily for 96 weeks |
| Control group | Active comparator | Drug: Tenofovir disoproxil fumarate tablet;Placebo of Pradefovir Mesylatesubject in this group will receive tenofovir disoproxil fumarate tablet and the placebo of Pradefovir mesylate tablet, once daily for 96 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age from 18 to 65 years old, male or female.
- Meets the diagnosis and treatment standards of chronic hepatitis B( HBsAg or HBV DNA positive over 6 months, or diagnosed by liver biopsy.
- For HBeAg positive, HBV DNA equal or over 20000 IU/ml; for HBeAg negative ,HBV DNA equal or over 2000 IU/ml.
- ALT level between 1.2 ULN to 10 UNL.
- Treatment naive or experienced when any nucleos(t)ide analogs or interferons stopped over 6 months.
Key exclusion criteria (17 listed)
- Allergic to study drug,metabolite product or excipient.
- Evidence of hepatic decompensation such as Child-Pugh B or C, with previous gastroesophageal variceal haemorrhage, hepatic encephalopathy, ascites
- Suspected or confirmed hepatocellular carcinoma, or AFP>50μg/L.
- Other liver diseases (such as Chronic alcoholic hepatitis, drug-induced hepatitis, autoimmune liver disease).
- Resistant to antiviral drugs (adefovir or tenofovir).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pradefovir Mesylate;Placebo of Tenofovir disoproxil fumarate tabletOnce daily | Drug | Trial group |
| Tenofovir disoproxil fumarate tablet;Placebo of Pradefovir MesylateOnce daily | Drug | Control group |
Primary outcome
HBV viral suppression
Time frame: After 48-week therapy
proportion of patients with hepatitis B virus(HBV) -DNA undetectable(<29IU/ml)
4 secondary outcomes
HBV viral suppression
Time frame: After therapy of 4, 8, 12, 24, 36, 72, 96, 144 weeks
HBV viral suppression
Time frame: After therapy of 4, 8, 12, 24, 48, 36, 72, 96, 144 weeks
The reduction of HBV DNA load
Time frame: at week 4, 8, 12, 24, 36, 48, 72, 96, 144
ALT normalization
Time frame: After therapy of 4, 8, 12, 24, 48, 36, 72, 96, 144 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junqi Niu, Dr. principal investigator
The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Chronic Hepatitis b, run by Xi'an Xintong Pharmaceutical Research Co.,Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact daidi Wang (+86 029 68790358, wangdd@xtyw.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBV viral suppression (time frame: After 48-week therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020.