Hepatitis BPhase 4NCT03084250
The Investigation of Peginterferon Alfa-2a on Optimal in Chronic Hepatitis B Patients Who Have a High Risk of HCC
A Phase 4 study testing Peginterferon Alfa-2A and Adefovir, entecavir,tenofovir, either of them in people with Hepatitis B, run by Shanghai Nanhui Nanhua Hospital at 1 site in China.
Trial summary
The CHB subjects who are cirrhosis, will be randomized to two groups. The subjects who go into group A will be treated by nucleotide analogue (NA) combination with peginterferon alfa-2a,180μg/week for 48 weeks. The subjects who go into group B will be treated by nucleotide analogue (NA) only for 48 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Peginterferon Alfa-2A and Adefovir, entecavir,tenofovir, either of them
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2017to 1 Dec 2023
- 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
- Male and female patients with age ≥18 and ≤65 years;
- There should be evidences that HBsAg has been positive for more than 6 months with HBsAb and HBeAb negative; HBV-related cirrhosis
- Women without ongoing pregnancy or breast feeding and both women and men willing to take an effective contraceptive measure during the treatment;
- Agree to participate in the study and sign the patient informed consent form.
Who cannot join
- Treated by immunosuppressant,immunomodulator,Systemic cytotoxic drug,herbs or HBIg within 6 months prior to the first dose of treatment;
- ALT≥10 X ULN or total bilirubin ≥2 X ULN;
- Allergic history to interferon;
- Co-infection with active hepatitis A, hepatitis C, hepatitis D and/or human immunodeficiency virus (HIV);
- Child-Pugh scores >7;
- History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures, thalassemia);
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- Pregnant or breast-feeding Women;
- Consuming alcohol in excess of 20g/day for women and 30g/day for men within 6 months prior to enrollment or drug taking history;
- ANC(absolute neutrophil count)<1.5x 10^9/L or PLT(platelet count)<90x 10^9/L
- Creatinine over upper limit of normal;
- History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as major depression or psychosis that treated with antidepressant medication or a major tranquilizer at therapeutic doses respectively at any time prior to 3 months or any history of the following: a suicidal attempt hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease;
- History of immunologically mediated disease, (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, rheumatoid arthritis etc.);
- History of esophageal varices bleeding or other evidence of esophageal varices bleeding or other symptoms consistent with decompensated liver disease;
- History of severe cardiac disease (e.g., New York Heart Association Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases);
- Hemodialysis patients or patients with renal insufficiency;
- History of a severe seizure disorder or current anticonvulsant use;
- Major organ transplantation or other evidence of severe illness, malignancy, or any other conditions, which would make the patient, in the opinion of the investigator, unsuitable for the study;
- History of thyroid disease poorly controlled on prescribed medications;
- Evidence of severe retinopathy or clinically relevant ophthalmologic disorder;
- History of other severe disease or evidence of other severe disease or any other illness or conditions that the investigator believe that patients are not suitable to join in the study;
- Patients included in another trial or having been given investigational drugs within 12 weeks prior to screening;
- AFP(alpha feto protein)>50ng/ml and/or evidence of hepatocellular carcinoma;
- Patients treated with Telbivudine;
- Other disease should exclusive considered by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Open-label Study of the Investigation of Peginterferon Alfa-2a on Optimal in Chronic Hepatitis B Patients Who Have a High Risk of HCC
The CHB subjects who are cirrhosis, will be randomized to two groups.
The subjects who go into group A will be treated by nucleotide analogue (NA) combination with peginterferon alfa-2a,180μg/week for 48 weeks.
The subjects who go into group B will be treated by nucleotide analogue (NA) only for 48 weeks.
Read the detailed description
This study is a prospective, randomized, open-label study.
The CHB subjects who are cirrhosis will be randomized to two groups.
The subjects who go into group A will be treated by nucleotide analogue (NA) combination with peginterferon alfa-2a,180μg/week for 48 weeks.
The subjects who go into group B will be treated by nucleotide analogue (NA) only for 48 weeks.
- Conditions
- Hepatitis B
- Being tested
- Peginterferon Alfa-2A, Adefovir, entecavir,tenofovir, either of them
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon Alfa-2ADrug
Also called Pegasys
180μg/week, 48 weeks; 135μg/week,48weeks
Adefovir, entecavir,tenofovir, either of themDrug
Adefovir, entecavir,tenofovir, either of them is ok
| Study group | Role | What they receive |
|---|---|---|
| Combination | Experimental | The subjects will be treated by nucleotide analogue (NA) combination with peginterferon alfa-2a Receives: Drug: Peginterferon Alfa-2A |
| nucleotide analogue | Active comparator | The subjects will be treated by nucleotide analogue (NA) only Receives: Drug: Adefovir, entecavir,tenofovir, either of them |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects who develop to hepatocellular carcinoma during 5 years
The number of subjects develop to hepatocellular carcinoma during 5 years will be measured
Measured: 5 years
Secondary outcomes (3)
Number of participants who achieve HBeAg loss and HBeAg seroconversion
The number of subjects with HBeAg loss and HBeAg seroconversion at year 1 ,2,3,4 and 5 will be measured
Measured: year 1,2,3,4,5
Number of participants who achieve HBsAg loss and HBsAg seroconversion
The number of subjects with HBsAg loss and HBsAg seroconversion at year 1, 2,3,4 and 5 will be measured
Measured: year 1,2,3,4,5
The factor such as HBsAg level related to the incidence of HCC development
The HBsAg level at year 1 will be measured, to assess whether the quantitative HBsAg level related to the incidence of HCC development
Measured: year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study start10 Mar 2017
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Nanhui Nanhua Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chenbo Hu, Shanghai Nanhui Nanhua Hospital
- Investigators
- Chenbo Hu, Principal investigator, Nanhua Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084250
- Sponsor's protocol ID
- High risk of HCC
- Status last verified
- May 2017
- First submitted
- 14 Mar 2017
- Last updated
- 3 May 2017
- 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 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open-label Study of the Investigation of Peginterferon Alfa-2a on Optimal in Chronic Hepatitis B Patients Who Have a High Risk of HCC
- ClinicalTrials.gov ID
- NCT03084250
- Acronym / sponsor ID
- High risk of HCC
- Conditions
- Hepatitis B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shanghai Nanhui Nanhua HospitalUniversity, hospital or other
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 20 Mar 2017 (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.
The CHB subjects who are cirrhosis, will be randomized to two groups.
The subjects who go into group A will be treated by nucleotide analogue (NA) combination with peginterferon alfa-2a,180μg/week for 48 weeks.
The subjects who go into group B will be treated by nucleotide analogue (NA) only for 48 weeks.
Detailed description
This study is a prospective, randomized, open-label study.
The CHB subjects who are cirrhosis will be randomized to two groups.
The subjects who go into group A will be treated by nucleotide analogue (NA) combination with peginterferon alfa-2a,180μg/week for 48 weeks.
The subjects who go into group B will be treated by nucleotide analogue (NA) only for 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination | Experimental | Drug: Peginterferon Alfa-2AThe subjects will be treated by nucleotide analogue (NA) combination with peginterferon alfa-2a |
| nucleotide analogue | Active comparator | Drug: Adefovir, entecavir,tenofovir, either of themThe subjects will be treated by nucleotide analogue (NA) only |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients with age ≥18 and ≤65 years;
- There should be evidences that HBsAg has been positive for more than 6 months with HBsAb and HBeAb negative; HBV-related cirrhosis
- Women without ongoing pregnancy or breast feeding and both women and men willing to take an effective contraceptive measure during the treatment;
- Agree to participate in the study and sign the patient informed consent form.
Key exclusion criteria (24 listed)
- Treated by immunosuppressant,immunomodulator,Systemic cytotoxic drug,herbs or HBIg within 6 months prior to the first dose of treatment;
- ALT≥10 X ULN or total bilirubin ≥2 X ULN;
- Allergic history to interferon;
- Co-infection with active hepatitis A, hepatitis C, hepatitis D and/or human immunodeficiency virus (HIV);
- Child-Pugh scores >7;
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 |
|---|---|---|
| Peginterferon Alfa-2AAlso: Pegasys180μg/week, 48 weeks; 135μg/week,48weeks | Drug | Combination |
| Adefovir, entecavir,tenofovir, either of themAdefovir, entecavir,tenofovir, either of them is ok | Drug | nucleotide analogue |
Primary outcome
Number of subjects who develop to hepatocellular carcinoma during 5 years
Time frame: 5 years
The number of subjects develop to hepatocellular carcinoma during 5 years will be measured
3 secondary outcomes
Number of participants who achieve HBeAg loss and HBeAg seroconversion
Time frame: year 1,2,3,4,5
Number of participants who achieve HBsAg loss and HBsAg seroconversion
Time frame: year 1,2,3,4,5
The factor such as HBsAg level related to the incidence of HCC development
Time frame: year 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
Related trials for Hepatitis B
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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.
Chenbo Hu principal investigator
Nanhua Hospital
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 Peginterferon Alfa-2A and Adefovir, entecavir,tenofovir, either of them in people with Hepatitis B, run by Shanghai Nanhui Nanhua Hospital 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 24 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 3 May 2017. 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?
Number of subjects who develop to hepatocellular carcinoma during 5 years (time frame: 5 years). 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 3 May 2017.