Chronic Hepatitis BPhase 4NCT01436539
Study of Effects and Safety Between Adefovir Dipivoxil Plus Polyene Phosphatidylcholine Versus Adefovir Dipivoxil Alone in Chronic Hepatitis B Patients
A Phase 4 study testing Adefovir Dipivoxil and polyene phosphatidylcholine and Adefovir Dipivoxil in people with Chronic Hepatitis B, run by Jun Cheng at 1 site in China.
Trial summary
The purpose of the study is to evaluate the effects and safety of Adefovir Dipivoxil plus polyene phosphatidylcholine compared to Adefovir Dipivoxil alone in patients with chronic hepatitis B. 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?
- Adefovir Dipivoxil and polyene phosphatidylcholine and Adefovir Dipivoxil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Sep 2011to Jul 2013
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females between the age of 18 to 65 years with chronic hepatitis B.
- HBsAg positive for a minimum of 6 months.
- HBV DNA ≥4 log10 copies/ml, and ≤ 6 log10 copies/mL
- Alanine aminotransferase (ALT) ≥ 2 times the upper limit of normal(ULN) and ≤10 times ULN, and documented ALT abnormal within 6 month prior to the study screening.
- Had a liver biopsy performed within 6 months prior to randomization and has readable biopsy slides or agrees to have a biopsy performed prior to entry.
- Willing and able to provide written informed consent.
Who cannot join
- Received any nucleoside, nucleotide or interferon therapy within 6 months prior to the screening.
- Previous treatment with lamivudine, adefovir, entecavir or telbivudine and occurred viral breakthrough or genotype resistance.
- Received immunosuppressive agents or other immunoregulates (including thymosin),systemic cytotoxic drugs, other antiviral agents including Chinese herb medicine within 6 months prior to the screening.
- Active alcohol intake( more than 20g/d for female or more than 30g/d for male) or drug abuse within 1 year prior to screening. Alcohol or drug abuse considered by the investigator to be sufficient to hinder compliance with treatment, participation in the study or interpretation of results.
- ALT is greater than 10 times ULN at screening or has the history of transient decompensated liver disease due to acute exacerbation.
- Any of the laboratory test at screening as the following :
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- serum creatinine > 1.5 mg/dl ;
- prothrombin time ≥ 4 seconds prolonged or PTA <60%;
- serum albumin<32 g/L;
- serum bilirubin>3.0mg/dL;
- Hemoglobin<11g/dL(males) or <10 g/dL(females), white blood cells count<3.5 x 10^9/L, absolute neutrophil count <1.5 x 10^9/L, platelets<80 x 10^9/L.
- Patient is coinfected with HCV, HDV or HIV.
- Hepatocellular carcinoma (HCC), or the presence of a mass on imaging studies of the liver that is suggest of HCC, or an alpha-fetoprotein (AFP)> 500ng/mL.
- Decompensated liver disease as defined by serum bilirubin >3mg/dL, prothrombin time≥ 4 seconds prolonged, a serum albumin<32g/L, or a history of ascites, variceal bleeding or hepatic encephalopathy.
- Presence of other causes of liver disease (i.e.alcoholic liver disease,autoimmune hepatitis, hemochromatosis, Wilson disease, nonalcoholic steatohepatitis, alpha-1anti-trypsin deficiency).
- Any serious or active medical or psychiatric illnesses other than hepatitis B which, in the opinion of the investigator, would interfere with patient treatment, assessment or compliance with the protocol. This would include, may not limit to, renal, cardiac, pulmonary, vascular, neurogenic, digestive, metabolic (diabetes, thyroid disorders, adrenal disease), immunodeficiency disorders, active infection or cancer.
- BMI≥30.
- Patient is pregnant or breast-feeding.
- Planned for liver transplantation or previous liver transplantation.
- Need take hepatotoxic drugs (e.g.,dapsone, erythromycin, fluconazole, rifampin, etc) and nephrotoxic drugs (e.g., NSAIDs, aminoglycosides, amphotericin B, foscarnet, etc.) for long time.
- History of hypersensitivity to nucleoside analogues.
- Previous (or planned) participation in an investigational trial involving administration of investigational compound within 12 weeks prior to the study screening.
- Poor compliance of the patient considered by investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Ditan Hospital, Capital Medical University
Beijing, 100015
Jun Cheng, post doctor
About this study
Official title: A Multi-center, Open Label, Randomized Study of Effects and Safety Between Adefovir Dipivoxil Plus Polyene Phosphatidylcholine Capsule Versus Adefovir Dipivoxil Alone in Chronic Hepatitis B Patients
The purpose of the study is to evaluate the effects and safety of Adefovir Dipivoxil plus polyene phosphatidylcholine compared to Adefovir Dipivoxil alone in patients with chronic hepatitis B.
- Conditions
- Chronic Hepatitis B
- Being tested
- Adefovir Dipivoxil and polyene phosphatidylcholine, Adefovir Dipivoxil
- 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.
Adefovir Dipivoxil and polyene phosphatidylcholineDrug
Adefovir Dipivoxil 10 mg once daily for 48 weeks plus Polyene phosphatidylcholine (PPC) 456 mg three times per day for 48 weeks
Adefovir DipivoxilDrug
Adefovir Dipivoxil 10 mg once daily for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| Adefovir Dipivoxil and polyene phosphatidylcholine | Experimental | Adefovir Dipivoxil 10 mg once daily for 48 weeks plus Polyene phosphatidylcholine (PPC) 456 mg three times per day for 48 weeks Receives: Drug: Adefovir Dipivoxil and polyene phosphatidylcholine |
| Adefovire Dipivoxil | Active comparator | Adefovir Dipivoxil 10 mg once daily for 48 weeks Receives: Drug: Adefovir Dipivoxil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportions of subjects with histological response in treatment and control group.
Measured: at week 48
Secondary outcomes (10)
Proportions of subjects in each group who achieve: HBV DNA < 300 copies/mL
Measured: at week 48
Mean log10 reduction from baseline in HBVDNA
Measured: at week 12, 24, 48
ALT normalization rate and range
Measured: at week 12 and 48
Liver stiffness values reduction from baseline by Fibroscan
Measured: at week 48
HBeAg loss and HBe seroconversion
Measured: at week 12 and 48
HBsAg loss and HBs seroconversion
Measured: at week 12 and 48
Improvement in symptoms score
Measured: at week 12, 24 and 48
Frequency of adverse events
Measured: up to 60 weeks
Frequency of serious adverse events
Measured: up to 60 weeks
Frequency of discontinuations from study drug due to adverse events or laboratory abnormalities.
Measured: up to 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2013 (estimated)
- Study completionJul 2013 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jun Cheng
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi, Fujian Cosunter Pharmaceutical Co. Ltd
- Responsible party
- Sponsor-investigator, Jun Cheng, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01436539
- Sponsor's protocol ID
- Ditan-2011-01
- Status last verified
- Sep 2011
- First submitted
- 13 Sep 2011
- Last updated
- 19 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open Label, Randomized Study of Effects and Safety Between Adefovir Dipivoxil Plus Polyene Phosphatidylcholine Capsule Versus Adefovir Dipivoxil Alone in Chronic Hepatitis B Patients
- ClinicalTrials.gov ID
- NCT01436539
- Acronym / sponsor ID
- Ditan-2011-01
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Jun ChengUniversity, hospital or other
- Collaborators
- Sanofi, Fujian Cosunter Pharmaceutical Co. Ltd
- Study start
- Sep 2011
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 19 Sep 2011 (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 the study is to evaluate the effects and safety of Adefovir Dipivoxil plus polyene phosphatidylcholine compared to Adefovir Dipivoxil alone in patients with chronic hepatitis B.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adefovir Dipivoxil and polyene phosphatidylcholine | Experimental | Drug: Adefovir Dipivoxil and polyene phosphatidylcholineAdefovir Dipivoxil 10 mg once daily for 48 weeks plus Polyene phosphatidylcholine (PPC) 456 mg three times per day for 48 weeks |
| Adefovire Dipivoxil | Active comparator | Drug: Adefovir DipivoxilAdefovir Dipivoxil 10 mg once daily for 48 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females between the age of 18 to 65 years with chronic hepatitis B.
- HBsAg positive for a minimum of 6 months.
- HBV DNA ≥4 log10 copies/ml, and ≤ 6 log10 copies/mL
- Alanine aminotransferase (ALT) ≥ 2 times the upper limit of normal(ULN) and ≤10 times ULN, and documented ALT abnormal within 6 month prior to the study screening.
- Had a liver biopsy performed within 6 months prior to randomization and has readable biopsy slides or agrees to have a biopsy performed prior to entry.
Key exclusion criteria (23 listed)
- Received any nucleoside, nucleotide or interferon therapy within 6 months prior to the screening.
- Previous treatment with lamivudine, adefovir, entecavir or telbivudine and occurred viral breakthrough or genotype resistance.
- Received immunosuppressive agents or other immunoregulates (including thymosin),systemic cytotoxic drugs, other antiviral agents including Chinese herb medicine within 6 months prior to the screening.
- Active alcohol intake( more than 20g/d for female or more than 30g/d for male) or drug abuse within 1 year prior to screening. Alcohol or drug abuse considered by the investigator to be sufficient to hinder compliance with treatment, participation in the study or interpretation of results.
- ALT is greater than 10 times ULN at screening or has the history of transient decompensated liver disease due to acute exacerbation.
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 |
|---|---|---|
| Adefovir Dipivoxil and polyene phosphatidylcholineAdefovir Dipivoxil 10 mg once daily for 48 weeks plus Polyene phosphatidylcholine (PPC) 456 mg three times per day for 48 weeks | Drug | Adefovir Dipivoxil and polyene phosphatidylcholine |
| Adefovir DipivoxilAdefovir Dipivoxil 10 mg once daily for 48 weeks | Drug | Adefovire Dipivoxil |
Primary outcome
Proportions of subjects with histological response in treatment and control group.
Time frame: at week 48
10 secondary outcomes
Proportions of subjects in each group who achieve: HBV DNA < 300 copies/mL
Time frame: at week 48
Mean log10 reduction from baseline in HBVDNA
Time frame: at week 12, 24, 48
ALT normalization rate and range
Time frame: at week 12 and 48
Liver stiffness values reduction from baseline by Fibroscan
Time frame: at week 48
HBeAg loss and HBe seroconversion
Time frame: at week 12 and 48
HBsAg loss and HBs seroconversion
Time frame: at week 12 and 48
Improvement in symptoms score
Time frame: at week 12, 24 and 48
Frequency of adverse events
Time frame: up to 60 weeks
Frequency of serious adverse events
Time frame: up to 60 weeks
Frequency of discontinuations from study drug due to adverse events or laboratory abnormalities.
Time frame: up to 60 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2011.
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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.
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 Adefovir Dipivoxil and polyene phosphatidylcholine and Adefovir Dipivoxil in people with Chronic Hepatitis B, run by Jun Cheng 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 6 inclusion and 23 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 19 Sep 2011. 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?
Results are not available in the source record.
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?
Proportions of subjects with histological response in treatment and control group. (time frame: at week 48). 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 19 Sep 2011.