Chronic Hepatitis BPhase 4NCT02202473
Oxymatrine Plus Lamivudine Combination Therapy Versus Lamivudine Monotherapy for Chronic Hepatitis B Infected Subjects
A Phase 4 study testing Lamivudine and Lamivudine+Oxymatrine Capsules in people with Chronic Hepatitis B, run by Southeast University, China at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy of Oxymatrine plus Lamivudine Combination Therapy and whether it could lower the incidence of Lamivudine long-term resistance compared to Lamivudine Monotherapy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Lamivudine and Lamivudine+Oxymatrine Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- Start not givento Feb 2014
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 to 60 years old.
- Subjects diagnosed as chronic hepatitis B according to 2000 Xi'an Conference Guidelines: Management of chronic hepatitis B. Alanine transaminase >80 IU/L, total bilirubin<85.5 mmol/L, Hepatitis B virus DNA >1×10^5copies/mL; haven't been treated with antiviral therapy within 6 months before screening.
- able to give written informed consent and to comply with the study protocol.
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study.
Who cannot join
- Evidence of hepatocellular carcinoma
- Clinical symptoms of Decompensated liver disease at screening, including but not limited to: Serum bilirubin≥1.5 x upper limit of normal, prothrombin time of greater than 2 seconds prolonged, a serum albumin< 32g/L, or a history of ascites, variceal bleeding, or hepatic encephalopathy;
- Alanine transaminase>10 x upper limit of normal at screening or history of Transient hepatic decompensation caused by acute exacerbation;
- hemoglobin< 10g/dL, Neutrophil count<1.5 × 10^9/L, platelet count< 80 × 10^9/L;
- Evidence of active liver disease from other causes, including co-infection with hepatitis A virus, co-infection with hepatitis E virus, co-infection with hepatitis C virus, co-infection with hepatitis D virus, co-infection with HIV, autoimmune hepatitis (antinuclear antibody titer> 1:100);
- Use of immunosuppressors, immunomodulators (including interferon or thymosin) within 6 months before enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the efficacy of Oxymatrine plus Lamivudine Combination Therapy and whether it could lower the incidence of Lamivudine long-term resistance compared to Lamivudine Monotherapy.
Read the detailed description
Group A (Lamivudine Monotherapy): Lamivudine (Manufacturer: GlaxoSmithKline) 100mg po, qd.
Group B (Oxymatrine + Lamivudine Combination Therapy): Lamivudine (Manufacturer: GlaxoSmithKline) 100mg po, qd; oxymatrine Capsules (Chia Tai Tianqing Pharmaceutical Group Co., Ltd) 200 mg, po, tid.
Total subjects: 200, 100 patients randomized in each group.
- Conditions
- Chronic Hepatitis B
- Being tested
- Lamivudine, Lamivudine+Oxymatrine Capsules
- Keywords
- Oxymatrine Capsules, lamivudine, 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.
LamivudineDrug
Lamivudine+Oxymatrine CapsulesDrug
| Study group | Role | What they receive |
|---|---|---|
| Lamivudine | Active comparator | Lamivudine (Manufacturer: GlaxoSmithKline) 100mg po, qd Receives: Drug: Lamivudine |
| Lamivudine+Oxymatrine Capsules | Experimental | Lamivudine (Manufacturer: GlaxoSmithKline) 100mg po, qd; oxymatrine Capsules (Chia Tai Tianqing Pharmaceutical Group Co., Ltd) 200 mg, po, tid. Receives: Drug: Lamivudine+Oxymatrine Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Hepatitis B virus DNA titer compared to Baseline Hepatitis B virus DNA titer every 3 months for 18 months
Measured: 1, 3, 6, 12, 15, 18 months
Secondary outcomes (1)
Hepatitis B virus resistance loci
Measured: 1, 3, 6, 12, 15, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2014 (estimated)
- Primary completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Collaborators
- Cttq
- Responsible party
- Principal investigator, Wei Zhao, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02202473
- Sponsor's protocol ID
- Oxymatrine
- Status last verified
- Jul 2014
- First submitted
- 24 Jul 2014
- Last updated
- 29 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lu FM, Zhuang H. Management of hepatitis B in China. Chin Med J (Engl). 2009 Jan 5;122(1):3-4. No abstract available.
PubMed 19187608Yuen MF, Fung J, Wong DK, Lai CL. Prevention and management of drug resistance for antihepatitis B treatment. Lancet Infect Dis. 2009 Apr;9(4):256-64. doi: 10.1016/S1473-3099(09)70056-8.
PubMed 19324298Wang YP, Zhao W, Xue R, Zhou ZX, Liu F, Han YX, Ren G, Peng ZG, Cen S, Chen HS, Li YH, Jiang JD. Oxymatrine inhibits hepatitis B infection with an advantage of overcoming drug-resistance. Antiviral Res. 2011 Mar;89(3):227-31. doi: 10.1016/j.antiviral.2011.01.005. Epub 2011 Jan 28.
PubMed 21277330
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxymatrine Plus Lamivudine Combination Therapy Versus Lamivudine Monotherapy for Chronic Hepatitis B Infected Subjects
- ClinicalTrials.gov ID
- NCT02202473
- Acronym / sponsor ID
- Oxymatrine
- Conditions
- Chronic Hepatitis B
- Keywords
- Oxymatrine Capsules, lamivudine, chronic Hepatitis B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Collaborators
- Cttq
- Primary completion
- Feb 2014 (actual)
- First posted
- 29 Jul 2014 (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 purpose of this study is to evaluate the efficacy of Oxymatrine plus Lamivudine Combination Therapy and whether it could lower the incidence of Lamivudine long-term resistance compared to Lamivudine Monotherapy.
Detailed description
Group A (Lamivudine Monotherapy): Lamivudine (Manufacturer: GlaxoSmithKline) 100mg po, qd.
Group B (Oxymatrine + Lamivudine Combination Therapy): Lamivudine (Manufacturer: GlaxoSmithKline) 100mg po, qd; oxymatrine Capsules (Chia Tai Tianqing Pharmaceutical Group Co., Ltd) 200 mg, po, tid.
Total subjects: 200, 100 patients randomized in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lamivudine | Active comparator | Drug: LamivudineLamivudine (Manufacturer: GlaxoSmithKline) 100mg po, qd |
| Lamivudine+Oxymatrine Capsules | Experimental | Drug: Lamivudine+Oxymatrine CapsulesLamivudine (Manufacturer: GlaxoSmithKline) 100mg po, qd; oxymatrine Capsules (Chia Tai Tianqing Pharmaceutical Group Co., Ltd) 200 mg, po, tid. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18 to 60 years old.
- Subjects diagnosed as chronic hepatitis B according to 2000 Xi'an Conference Guidelines: Management of chronic hepatitis B. Alanine transaminase >80 IU/L, total bilirubin<85.5 mmol/L, Hepatitis B virus DNA >1×10^5copies/mL; haven't been treated with antiviral therapy within 6 months before screening.
- able to give written informed consent and to comply with the study protocol.
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study.
Key exclusion criteria (6 listed)
- Evidence of hepatocellular carcinoma
- Clinical symptoms of Decompensated liver disease at screening, including but not limited to: Serum bilirubin≥1.5 x upper limit of normal, prothrombin time of greater than 2 seconds prolonged, a serum albumin< 32g/L, or a history of ascites, variceal bleeding, or hepatic encephalopathy;
- Alanine transaminase>10 x upper limit of normal at screening or history of Transient hepatic decompensation caused by acute exacerbation;
- hemoglobin< 10g/dL, Neutrophil count<1.5 × 10^9/L, platelet count< 80 × 10^9/L;
- Evidence of active liver disease from other causes, including co-infection with hepatitis A virus, co-infection with hepatitis E virus, co-infection with hepatitis C virus, co-infection with hepatitis D virus, co-infection with HIV, autoimmune hepatitis (antinuclear antibody titer> 1:100);
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 |
|---|---|---|
| Lamivudine | Drug | Lamivudine |
| Lamivudine+Oxymatrine Capsules | Drug | Lamivudine+Oxymatrine Capsules |
Primary outcome
Reduction of Hepatitis B virus DNA titer compared to Baseline Hepatitis B virus DNA titer every 3 months for 18 months
Time frame: 1, 3, 6, 12, 15, 18 months
1 secondary outcome
Hepatitis B virus resistance loci
Time frame: 1, 3, 6, 12, 15, 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2014.
- Background: PubMed 19187608Lu FM, Zhuang H. Management of hepatitis B in China. Chin Med J (Engl). 2009 Jan 5;122(1):3-4. No abstract available.
- Background: PubMed 19324298Yuen MF, Fung J, Wong DK, Lai CL. Prevention and management of drug resistance for antihepatitis B treatment. Lancet Infect Dis. 2009 Apr;9(4):256-64. doi: 10.1016/S1473-3099(09)70056-8.
- Background: PubMed 21277330Wang YP, Zhao W, Xue R, Zhou ZX, Liu F, Han YX, Ren G, Peng ZG, Cen S, Chen HS, Li YH, Jiang JD. Oxymatrine inhibits hepatitis B infection with an advantage of overcoming drug-resistance. Antiviral Res. 2011 Mar;89(3):227-31. doi: 10.1016/j.antiviral.2011.01.005. Epub 2011 Jan 28.
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Chronic Hepatitis B
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lamivudine and Lamivudine+Oxymatrine Capsules in people with Chronic Hepatitis B, run by Southeast University, China 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 29 Jul 2014. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of Hepatitis B virus DNA titer compared to Baseline Hepatitis B virus DNA titer every 3 months for 18 months (time frame: 1, 3, 6, 12, 15, 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02202473, which also lists 3 linked publications.
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 29 Jul 2014.