Chronic Hepatitis BPhase 2NCT02965859
The Safety and Dose-range Study of Metacavir Enteric-coated Capsules in Patients With Chronic Hepatitis B
A Phase 2 study testing Metacavir Enteric-coated Capsules 80mg, Metacavir Enteric-coated Capsules 160mg and Metacavir Enteric-coated Capsules 320mg in people with Chronic Hepatitis B, run by Guangzhou Yipinhong Pharmaceutical CO.,LTD at 1 site in China.
Trial summary
The study objective is to evaluate the safety and effectiveness of different doses of Metacavir Enteric-coated Capsules in treatment of chronic hepatitis B,as well as to find an appropriate clinical dosage by comparing the effect of different doses of treatment,in order to provide references of clinical trial of the… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Metacavir Enteric-coated Capsules 80mg, Metacavir Enteric-coated Capsules 160mg and Metacavir Enteric-coated Capsules 320mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Dec 2018
- Phase
- Phase 2
- 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
- Are at least 18 years of age and no older than 65;
- Subjects,with an established clinical history of HBV at Screening,has a positive HBsAg test(>6months) regardless of a positive/negative HBeAg test;
- At Screening,HBV-DNA>10^5 copies/ml in HBeAg positive or HBV-DNA>10^4 copies/ml in HBeAg negative(HBV-DNA was evaluated by polymerase chain reaction fluorescent labeling.);
- Subjects with abnormal liver function test defined as alanine aminotransferase(ALT) was 2~10 times upper limit of normal in HBeAg positive or 1.5~10 times upper limit of normal in HBeAg negative;
- Subjects who are willing to require any other treatment for anti-hepatitis B during the study period;
- Subjects who are willing to take measures for effective non-pharmaceutical contraception;
- Given their signed written informed consent to participate;
Who cannot join
- Subjects with hepatitis C(HCV),hepatitis D(HDV),autoimmune hepatitis,hereditary liver disease or any other active hepatitis;
- A positive human immunodeficiency virus(HIV) test result;
- Subjects,who in the opinion of the investigator,have a current diagnosis of hepatocellular carcinoma or serum α-fetoprotein(AFP)>100ug/L;
- Subjects with severe hepatitis or decompensated liver disease defined as hepatic encephalopathy,ascites,low protein blood syndrome(albumin ≤30g/l) or variceal bleeding;
- Serum Creatinine(SCr) exceeds upper limit of normal;
- At Screening,ALT>10 times upper limit of normal,Total Bilirubin(TBIL)>double upper limit of normal or transient hepatic decompensation caused by condition aggravation;
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- Subjects who required treatment with nucleoside antiviral drugs such as lamivudine,Adefovir dipivoxil,Telbivudine,Tenofovir disoproxil or Entecavir before Screening;
- Subjects who require treatment with interferon-α，thymosin α-1 or other antiviral therapy,immunosuppressive agents,immune modulators within 6 months before Screening;
- Subjects with cardiac disease,hematological system disease,cancer,impaired immunity or psychiatric disease;
- Hemoglobin<10g/dl,white blood cell count<3.5 10^9/L,platelets<80 10^9/L;
- Subjects,who in the opinion of the investigator,have a current diagnosis of pancreatitis pre-dose within 24 weeks;
- History of hypersensitivity or allergy to any of the study drugs;
- Subjects who participate in other clinical trials within 3 months prior to Screening;
- Women who are pregnant or lactating or planning a pregnancy recently;
- Subjects in the opinion of the investigator,could not participate in the study.
Trial locations and contacts
1 site in 1 country.
Maorong Wang contact
China1 site, 1 recruiting
- Recruiting
81 Military Hospital of China
Nanjing, Jiangsu
Maorong Wang, 025-80864021
Maorong Wang
About this study
Official title: A Randomized,Double-blind,Double-dummy,Multiple-dose Parallel Control,Multiple Centers Study to Assess the Safety and Dose-range of Metacavir Enteric-coated Capsules for Patients With Chronic Hepatitis B
The study objective is to evaluate the safety and effectiveness of different doses of Metacavir Enteric-coated Capsules in treatment of chronic hepatitis B,as well as to find an appropriate clinical dosage by comparing the effect of different doses of treatment,in order to provide references of clinical trial of the next phase.
Read the detailed description
180 eligible subjects will be included.According to the set grouping method of dose escalation.Subjects will be randomized in a 1:1:1:1 proportion of Metacavir Enteric-coated Capsules(80mg/160mg/320mg) group,positive control group or placebo control group.Each group has 36 subjects.
1.Subjects will use the study medication(2 hours before or after meal,once a day) from Visit 3 to Visit 5.
- Metacavir Enteric-coated Capsules 80mg Group:Metacavir Enteric-coated Capsules 80mg,Metacavir Enteric-coated Capsules Placebo 240mg,Adefovir Dipivoxil Capsule Placebo 10mg;
- Metacavir Enteric-coated Capsules 160mg Group:Metacavir Enteric-coated Capsules 160mg,Metacavir Enteric-coated Capsules Placebo 160mg,Adefovir Dipivoxil Capsule Placebo 10mg;
- Metacavir Enteric-coated Capsules 320mg Group:Metacavir Enteric-coated Capsules 320mg,Adefovir Dipivoxil Capsule Placebo 10mg;
- Positive Control(Adefovir Dipivoxil Capsule) Group:Metacavir Enteric-coated Capsules Placebo 320mg,Adefovir Dipivoxil Capsule 10mg;
- Placebo Control Group:Metacavir Enteric-coated Capsules Placebo 320mg,Adefovir Dipivoxil Capsule Placebo 10mg;
- Conditions
- Chronic Hepatitis B
- Being tested
- Metacavir Enteric-coated Capsules 80mg, Metacavir Enteric-coated Capsules 160mg, Metacavir Enteric-coated Capsules 320mg, Metacavir Enteric-coated Capsules Placebo 240mg, Metacavir Enteric-coated Capsules Placebo 160mg
- Keywords
- Chronic Hepatitis B
- 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.
Metacavir Enteric-coated Capsules 80mgDrug
Metacavir Enteric-coated Capsules 80mg
Metacavir Enteric-coated Capsules 160mgDrug
Metacavir Enteric-coated Capsules 160mg
Metacavir Enteric-coated Capsules 320mgDrug
Metacavir Enteric-coated Capsules 320mg
Metacavir Enteric-coated Capsules Placebo 240mgDrug
Metacavir Enteric-coated Capsules Placebo 240mg
Metacavir Enteric-coated Capsules Placebo 160mgDrug
Metacavir Enteric-coated Capsules Placebo 160mg
Metacavir Enteric-coated Capsules Placebo 320mgDrug
Metacavir Enteric-coated Capsules Placebo 320mg
Adefovir Dipivoxil Capsule10mgDrug
Adefovir Dipivoxil Capsule10mg
Adefovir Dipivoxil Capsule Placebo 10mgDrug
Adefovir Dipivoxil Capsule Placebo 10mg
| Study group | Role | What they receive |
|---|---|---|
| Metacavir Enteric-coated Capsule 80mg | Experimental | 1. Metacavir Enteric-coated Capsules 80mg
2. Metacavir Enteric-coated Capsules Placebo 240mg
3. Adefovir Dipivoxil Capsule Placebo 10mg; Receives: Drug: Metacavir Enteric-coated Capsules 80mg; Drug: Metacavir Enteric-coated Capsules Placebo 240mg; Drug: Adefovir Dipivoxil Capsule Placebo 10mg |
| Metacavir Enteric-coated Capsules 160mg | Active comparator | 1. Metacavir Enteric-coated Capsules 160mg
2. Metacavir Enteric-coated Capsules Placebo 160mg
3. Adefovir Dipivoxil Capsule Placebo 10mg; Receives: Drug: Metacavir Enteric-coated Capsules 160mg; Drug: Metacavir Enteric-coated Capsules Placebo 160mg; Drug: Adefovir Dipivoxil Capsule Placebo 10mg |
| Metacavir Enteric-coated Capsules 320mg | Placebo comparator | 1. Metacavir Enteric-coated Capsules 320mg
2. Adefovir Dipivoxil Capsule Placebo 10mg Receives: Drug: Metacavir Enteric-coated Capsules 320mg; Drug: Adefovir Dipivoxil Capsule Placebo 10mg |
| Adefovir Dipivoxil Capsule | Active comparator | 1. Metacavir Enteric-coated Capsules Placebo 320mg
2. Adefovir Dipivoxil Capsule 10mg; Receives: Drug: Metacavir Enteric-coated Capsules Placebo 320mg; Drug: Adefovir Dipivoxil Capsule10mg |
| Placebo | Placebo comparator | 1. Metacavir Enteric-coated Capsules Placebo 320mg
2. Adefovir Dipivoxil Capsule Placebo 10mg; Receives: Drug: Metacavir Enteric-coated Capsules 320mg; Drug: Metacavir Enteric-coated Capsules Placebo 320mg; Drug: Adefovir Dipivoxil Capsule Placebo 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline in the logarithms of measurement data of HBV-DNA at Week 12 of treatment.
The change from baseline in the logarithms of measurement data of HBV-DNA at Week 12 of treatment.（Unit：log10)
Measured: 12 weeks
Secondary outcomes (2)
Incidence of treatment-chronic hepatitis B
- The proportion of subjects whose HBV-DNA are down to double logarithms at Week 12 of treatment.(Unit：%)
- The proportion of subjects whose HBV-DNA are not detected or less than upper limit of normal at Week 12 of treatment.(Unit：%)
- The proportion of subjects (HBeAg positive at baseline) whose is changed at Week 12 of treatment.(Unit：%)
- The proportion of subjects whose HBsAg is changed to negative at Week 12 of treatment.(Unit：%)
Measured: 12 weeks
Incidence of Adverse Events(AEs)
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startDec 2012
- Primary completionDec 2018 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Yipinhong Pharmaceutical CO.,LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maorong Wang, Principal investigator, 81 Military Hospital of ChinaYonggang Li, Principal investigator, Beijing 302 HospitalYongfeng Yang, Principal investigator, The Second Hospital of Nanjing Medical UniversityYanlin Yu, Principal investigator, Wannan Medical College Yijishan HospitalJun Li, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965859
- Sponsor's protocol ID
- PNA-20140110-v2
- Status last verified
- Aug 2016
- First submitted
- 1 Sep 2016
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized,Double-blind,Double-dummy,Multiple-dose Parallel Control,Multiple Centers Study to Assess the Safety and Dose-range of Metacavir Enteric-coated Capsules for Patients With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT02965859
- Acronym / sponsor ID
- PNA-20140110-v2
- Conditions
- Chronic Hepatitis B
- Keywords
- Chronic Hepatitis B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Guangzhou Yipinhong Pharmaceutical CO.,LTDIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Dec 2018 (estimated)
- First posted
- 17 Nov 2016 (estimated)
- 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.
The study objective is to evaluate the safety and effectiveness of different doses of Metacavir Enteric-coated Capsules in treatment of chronic hepatitis B,as well as to find an appropriate clinical dosage by comparing the effect of different doses of treatment,in order to provide references of clinical trial of the next phase.
Detailed description
180 eligible subjects will be included.According to the set grouping method of dose escalation.Subjects will be randomized in a 1:1:1:1 proportion of Metacavir Enteric-coated Capsules(80mg/160mg/320mg) group,positive control group or placebo control group.Each group has 36 subjects.
1.Subjects will use the study medication(2 hours before or after meal,once a day) from Visit 3 to Visit 5.
- Metacavir Enteric-coated Capsules 80mg Group:Metacavir Enteric-coated Capsules 80mg,Metacavir Enteric-coated Capsules Placebo 240mg,Adefovir Dipivoxil Capsule Placebo 10mg;
- Metacavir Enteric-coated Capsules 160mg Group:Metacavir Enteric-coated Capsules 160mg,Metacavir Enteric-coated Capsules Placebo 160mg,Adefovir Dipivoxil Capsule Placebo 10mg;
- Metacavir Enteric-coated Capsules 320mg Group:Metacavir Enteric-coated Capsules 320mg,Adefovir Dipivoxil Capsule Placebo 10mg;
- Positive Control(Adefovir Dipivoxil Capsule) Group:Metacavir Enteric-coated Capsules Placebo 320mg,Adefovir Dipivoxil Capsule 10mg;
- Placebo Control Group:Metacavir Enteric-coated Capsules Placebo 320mg,Adefovir Dipivoxil Capsule Placebo 10mg;
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Metacavir Enteric-coated Capsule 80mg | Experimental | Drug: Metacavir Enteric-coated Capsules 80mg, Drug: Metacavir Enteric-coated Capsules Placebo 240mg, Drug: Adefovir Dipivoxil Capsule Placebo 10mg1. Metacavir Enteric-coated Capsules 80mg 2. Metacavir Enteric-coated Capsules Placebo 240mg 3. Adefovir Dipivoxil Capsule Placebo 10mg; |
| Metacavir Enteric-coated Capsules 160mg | Active comparator | Drug: Metacavir Enteric-coated Capsules 160mg, Drug: Metacavir Enteric-coated Capsules Placebo 160mg, Drug: Adefovir Dipivoxil Capsule Placebo 10mg1. Metacavir Enteric-coated Capsules 160mg 2. Metacavir Enteric-coated Capsules Placebo 160mg 3. Adefovir Dipivoxil Capsule Placebo 10mg; |
| Metacavir Enteric-coated Capsules 320mg | Placebo comparator | Drug: Metacavir Enteric-coated Capsules 320mg, Drug: Adefovir Dipivoxil Capsule Placebo 10mg1. Metacavir Enteric-coated Capsules 320mg 2. Adefovir Dipivoxil Capsule Placebo 10mg |
| Adefovir Dipivoxil Capsule | Active comparator | Drug: Metacavir Enteric-coated Capsules Placebo 320mg, Drug: Adefovir Dipivoxil Capsule10mg1. Metacavir Enteric-coated Capsules Placebo 320mg 2. Adefovir Dipivoxil Capsule 10mg; |
| Placebo | Placebo comparator | Drug: Metacavir Enteric-coated Capsules 320mg, Drug: Metacavir Enteric-coated Capsules Placebo 320mg, Drug: Adefovir Dipivoxil Capsule Placebo 10mg1. Metacavir Enteric-coated Capsules Placebo 320mg 2. Adefovir Dipivoxil Capsule Placebo 10mg; |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Are at least 18 years of age and no older than 65;
- Subjects,with an established clinical history of HBV at Screening,has a positive HBsAg test(>6months) regardless of a positive/negative HBeAg test;
- At Screening,HBV-DNA>10^5 copies/ml in HBeAg positive or HBV-DNA>10^4 copies/ml in HBeAg negative(HBV-DNA was evaluated by polymerase chain reaction fluorescent labeling.);
- Subjects with abnormal liver function test defined as alanine aminotransferase(ALT) was 2~10 times upper limit of normal in HBeAg positive or 1.5~10 times upper limit of normal in HBeAg negative;
- Subjects who are willing to require any other treatment for anti-hepatitis B during the study period;
Key exclusion criteria (15 listed)
- Subjects with hepatitis C(HCV),hepatitis D(HDV),autoimmune hepatitis,hereditary liver disease or any other active hepatitis;
- A positive human immunodeficiency virus(HIV) test result;
- Subjects,who in the opinion of the investigator,have a current diagnosis of hepatocellular carcinoma or serum α-fetoprotein(AFP)>100ug/L;
- Subjects with severe hepatitis or decompensated liver disease defined as hepatic encephalopathy,ascites,low protein blood syndrome(albumin ≤30g/l) or variceal bleeding;
- Serum Creatinine(SCr) exceeds upper limit of normal;
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 |
|---|---|---|
| Metacavir Enteric-coated Capsules 80mgMetacavir Enteric-coated Capsules 80mg | Drug | Metacavir Enteric-coated Capsule 80mg |
| Metacavir Enteric-coated Capsules 160mgMetacavir Enteric-coated Capsules 160mg | Drug | Metacavir Enteric-coated Capsules 160mg |
| Metacavir Enteric-coated Capsules 320mgMetacavir Enteric-coated Capsules 320mg | Drug | Metacavir Enteric-coated Capsules 320mg, Placebo |
| Metacavir Enteric-coated Capsules Placebo 240mgMetacavir Enteric-coated Capsules Placebo 240mg | Drug | Metacavir Enteric-coated Capsule 80mg |
| Metacavir Enteric-coated Capsules Placebo 160mgMetacavir Enteric-coated Capsules Placebo 160mg | Drug | Metacavir Enteric-coated Capsules 160mg |
| Metacavir Enteric-coated Capsules Placebo 320mgMetacavir Enteric-coated Capsules Placebo 320mg | Drug | Adefovir Dipivoxil Capsule, Placebo |
| Adefovir Dipivoxil Capsule10mgAdefovir Dipivoxil Capsule10mg | Drug | Adefovir Dipivoxil Capsule |
| Adefovir Dipivoxil Capsule Placebo 10mgAdefovir Dipivoxil Capsule Placebo 10mg | Drug | Metacavir Enteric-coated Capsule 80mg, Metacavir Enteric-coated Capsules 160mg, Metacavir Enteric-coated Capsules 320mg, Placebo |
Primary outcome
The change from baseline in the logarithms of measurement data of HBV-DNA at Week 12 of treatment.
Time frame: 12 weeks
The change from baseline in the logarithms of measurement data of HBV-DNA at Week 12 of treatment.（Unit：log10)
2 secondary outcomes
Incidence of treatment-chronic hepatitis B
Time frame: 12 weeks
Incidence of Adverse Events(AEs)
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
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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.
Maorong Wang contact
Maorong Wang principal investigator
81 Military Hospital of China
Yonggang Li principal investigator
Beijing 302 Hospital
Yongfeng Yang principal investigator
The Second Hospital of Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metacavir Enteric-coated Capsules 80mg, Metacavir Enteric-coated Capsules 160mg and Metacavir Enteric-coated Capsules 320mg in people with Chronic Hepatitis B, run by Guangzhou Yipinhong Pharmaceutical 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 15 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 22 Nov 2016. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Maorong Wang (025-80864021), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change from baseline in the logarithms of measurement data of HBV-DNA at Week 12 of treatment. (time frame: 12 weeks). 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 22 Nov 2016.