Chronic Hepatitis BPhase 4NCT00291616
Efficacy Study of Thymosin alpha1 & Pegylated Interferon-alpha2a to Treat Chronic Hepatitis B
A Phase 4 study testing Pegylated Interferon-alpha2a and Thymosin alpha1 & Pegylated Interferon-alpha2a in people with Chronic Hepatitis B, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to determine the optimal treatment duration of antiviral therapy for chronic hepatitis B. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Pegylated Interferon-alpha2a and Thymosin alpha1 & Pegylated Interferon-alpha2a
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2005to Aug 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HBsAg positive and anti-HBs negative for more than 6 months
- HBeAg positive
- HBV DNA titer more than 100,000 IU/mL
- serum ALT more than upper normal limit value, but no more than 10 times upper normal limit value
Who cannot join
- the history of antiviral therapy for chronic hepatitis B within the recent 6 months
- HAV IgM Ab + and/or HCV Ab + and/or HDV Ab and/or HIV Ab +
- the sign of decompensated liver disease
- the history of hemoglobinopathy, autoimmune hepatitis, alcoholic liver disease
- pregnant or lactating woman
- neutrophil count less than 1,500/mm3 or platelet count less than 90,000/mm3
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- serum creatinine more than 1.5 times upper normal limit value
- the sign of alcoholic or drug addiction within the recent 1 year
- the history of psychotic disorder especially like depression
- immunologically mediated disease
- the history of esophageal varix
- the history of severe heart disease or respiratory disease
- the history of severe epilepsy or current use of antiepileptic drug
- the sign of malignancy or suggestive of malignancy or the history of malignancy, the recurrence rate within 2 years of which is more than 20%
- the history of systemic anticancer treatment including radiation therapy or immunotherapy including systemic corticosteroid
- the history of major organ transplantation
- the history of medically uncontrolled thyroid disease
- the history or sign of severe retinopathy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Chongno-gu, 110-744
About this study
Official title: A Multicenter, Randomized, Controlled Trial of Combination Therapy for HBeAg Positive Chronic Hepatitis B: Comparing Thymosin Alpha 1 and Pegylated Interferon-alpha2a With Pegylated Interferon-alpha2a Alone.
The purpose of this study is to determine the optimal treatment duration of antiviral therapy for chronic hepatitis B.
Read the detailed description
Thymosin alpha1/interferon combination therapy has been known as an effective antiviral therapy for chronic hepatitis B. It is superior to interferon single therapy since the sustained viral response rate of combination therapy used to be about 70% compared with that of single interferon therapy(20%). Until now, the combination therapy including 6-month treatment of thymosin alpha1 has been as effective as 12-month treatment of thymosin alpha1. We hypothesized that thymosin alpha1 is an immune potentiator so, the shorter duration of thymosin alpha1 treatment might be as effective as the prolonged treatment duration.
In detail, we designed to perform this clinical study comparing the combination of pegylated interferon and thymosin alpha1 with pegylated interferon alone. Total treatment duration of both parallel groups will be 12 months, and the combination therapy will be lasted for the first 3 months followed by the next, ongoing pegylated interferon single therapy for 9 months.
- Conditions
- Chronic Hepatitis B
- Being tested
- Pegylated Interferon-alpha2a, Thymosin alpha1 & Pegylated Interferon-alpha2a
- Keywords
- chronic hepatitis B, pegylated interferon, thymosin alpha
- 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.
Pegylated Interferon-alpha2aDrug
180 microgram s.c. injection weekly
Thymosin alpha1 & Pegylated Interferon-alpha2aDrug
Pegylated interferon 180 microgram s.c. injection weekly Thymosin 1.6 mg s.c. injection twice per week
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Pegylated Interferon-alpha2a Receives: Drug: Pegylated Interferon-alpha2a |
| 2 | Active comparator | Thymosin alpha1 \& Pegylated Interferon-alpha2a Receives: Drug: Thymosin alpha1 & Pegylated Interferon-alpha2a |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBeAg seroconversion, HBV DNA titer<20,000 IU/mL
Measured: 48 week and 96 week
Secondary outcomes (1)
Normalization of serum ALT, loss of HBeAg and HBsAg, production of anti-HBs
Measured: 48 week and 96 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2006 (estimated)
- Study startDec 2005
- Primary completionAug 2008
- Study completionAug 2008
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.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG, SciClone Pharmaceuticals
- Investigators
- Jung H Yoon, M.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00291616
- Sponsor's protocol ID
- 12-05-008
- Status last verified
- Jul 2011
- First submitted
- 13 Feb 2006
- Last updated
- 21 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled Trial of Combination Therapy for HBeAg Positive Chronic Hepatitis B: Comparing Thymosin Alpha 1 and Pegylated Interferon-alpha2a With Pegylated Interferon-alpha2a Alone.
- ClinicalTrials.gov ID
- NCT00291616
- Acronym / sponsor ID
- 12-05-008
- Conditions
- Chronic Hepatitis B
- Keywords
- chronic hepatitis B, pegylated interferon, thymosin alpha
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Roche Pharma AG, SciClone Pharmaceuticals
- Study start
- Dec 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 14 Feb 2006 (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 determine the optimal treatment duration of antiviral therapy for chronic hepatitis B.
Detailed description
Thymosin alpha1/interferon combination therapy has been known as an effective antiviral therapy for chronic hepatitis B. It is superior to interferon single therapy since the sustained viral response rate of combination therapy used to be about 70% compared with that of single interferon therapy(20%). Until now, the combination therapy including 6-month treatment of thymosin alpha1 has been as effective as 12-month treatment of thymosin alpha1. We hypothesized that thymosin alpha1 is an immune potentiator so, the shorter duration of thymosin alpha1 treatment might be as effective as the prolonged treatment duration.
In detail, we designed to perform this clinical study comparing the combination of pegylated interferon and thymosin alpha1 with pegylated interferon alone. Total treatment duration of both parallel groups will be 12 months, and the combination therapy will be lasted for the first 3 months followed by the next, ongoing pegylated interferon single therapy for 9 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Pegylated Interferon-alpha2aPegylated Interferon-alpha2a |
| 2 | Active comparator | Drug: Thymosin alpha1 & Pegylated Interferon-alpha2aThymosin alpha1 \& Pegylated Interferon-alpha2a |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HBsAg positive and anti-HBs negative for more than 6 months
- HBeAg positive
- HBV DNA titer more than 100,000 IU/mL
- serum ALT more than upper normal limit value, but no more than 10 times upper normal limit value
Key exclusion criteria (18 listed)
- the history of antiviral therapy for chronic hepatitis B within the recent 6 months
- HAV IgM Ab + and/or HCV Ab + and/or HDV Ab and/or HIV Ab +
- the sign of decompensated liver disease
- the history of hemoglobinopathy, autoimmune hepatitis, alcoholic liver disease
- pregnant or lactating woman
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 |
|---|---|---|
| Pegylated Interferon-alpha2a180 microgram s.c. injection weekly | Drug | 1 |
| Thymosin alpha1 & Pegylated Interferon-alpha2aPegylated interferon 180 microgram s.c. injection weekly Thymosin 1.6 mg s.c. injection twice per week | Drug | 2 |
Primary outcome
HBeAg seroconversion, HBV DNA titer<20,000 IU/mL
Time frame: 48 week and 96 week
1 secondary outcome
Normalization of serum ALT, loss of HBeAg and HBsAg, production of anti-HBs
Time frame: 48 week and 96 week
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 21 Jul 2011.
Related trials for Chronic Hepatitis B
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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.
Jung H Yoon, M.D. principal investigator
Seoul National University 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 Pegylated Interferon-alpha2a and Thymosin alpha1 & Pegylated Interferon-alpha2a in people with Chronic Hepatitis B, run by Seoul National University Hospital at 1 site in South Korea.
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 18 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 21 Jul 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 South Korea. 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?
HBeAg seroconversion, HBV DNA titer<20,000 IU/mL (time frame: 48 week and 96 week). 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 21 Jul 2011.