HBeAg(+) Chronic Hepatitis BPhase 4NCT01264367
A Study to Evaluate the Efficacy and Safety of Clevudine and Peg-interferon in Sequence Compared With Clevudine Alone in the Patients With HBeAg(+) Chronic Hepatitis B or Clevudine and Peg-interferon Sequential Treatment in Patients With Chronic Hepatitis B Who Have HBeAg(+)
A Phase 4 study testing Clevudine and Clevudine + Peg-interferon in people with HBeAg(+) Chronic Hepatitis B, run by Bukwang Pharmaceutical at 1 site in South Korea.
Trial summary
A study to evaluate the efficacy and safety of clevudine and peg-interferon in sequence compared with clevudine alone in the patients with HBeAg(+) chronic Hepatitis B or clevudine and peg-interferon sequential treatment in patients with chronic Hepatitis B who have HBeAg(+) Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HBeAg(+) Chronic Hepatitis B
- What is being tested?
- Clevudine and Clevudine + Peg-interferon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2008to May 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
- Patient is between 18~60 years
- Patient is HBV DNA positive with DNA levels ≥ 5 x 10^5 copies/mL within 30 days of baseline.
- Patient is documented to be HBsAg positive for > 6 months and Patient is HBeAg positive.
- Patient has ALT levels >=80IU/L, prothrombin time(INR)<1.7 and a serum albumin level of at least 3.5 g/dL.
- Patient has hemoglobin levels >=11.5g/dl(if woman) or >=12.5g/dl(if man)
- Women of childbearing potential must have a negative urine pregnancy test(β-HCG) taken within 14 days of starting therapy.
- Patient is able to give written informed consent prior to study start and to comply with the study requirements.
Who cannot join
- Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
- Patients previously treated with interferon, peg-interferon, clevudine, lamivudine, adefovir, entecavir, telbivudine, tenofovir or any other investigational nucleoside for HBV infection.
- Patient is coinfected with HCV or HIV.
- Patient with clinical evidence of decompensated liver disease or HCC
- Patient has WBC levels < 3.0x10^9/L
- Patient has Platelets levels < 90x10^9/L
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- Patient has alpha fetoprotein levels > 100ng/mL
- Patient has a history of Thyroid disease.
- Patient has a history of autoimmune hepatitis.
- Patient is pregnant or breast-feeding.
- Patient is unwilling to use an "effective" method of contraception during the study and for up to 3 months after the use of study drug ceases.
- Patient has a clinically relevant history of abuse of alcohol or drugs.
- Patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic or allergic disease or medical illness that in the investigator's opinion might interfere with therapy. The patient with a benign tumor, excluded if judged by an investigator that the continuation of study would be interfered by the tumor.
- Patient has creatinine clearance less than 60mL/min as estimated by the following formula: (140-age in years) (body weight [kg])/(72) (serum creatinine [mg/dL]) [Note: multiply estimates by 0.85 for women]
Trial locations and contacts
1 site in 1 country.
About this study
A study to evaluate the efficacy and safety of clevudine and peg-interferon in sequence compared with clevudine alone in the patients with HBeAg(+) chronic Hepatitis B or clevudine and peg-interferon sequential treatment in patients with chronic Hepatitis B who have HBeAg(+)
- Conditions
- HBeAg(+) Chronic Hepatitis B
- Being tested
- Clevudine, Clevudine + Peg-interferon
- 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.
ClevudineDrug
Also called Levovir
30mg,QD
Clevudine + Peg-interferonDrug
Also called Levovir + Pagasys
30mg, QD(for 24 weeks) + 180mcg,QW(for 24 weeks)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Clevudine 30mg Receives: Drug: Clevudine |
| 2 | Active comparator | Clevudine 30mg + peg-interferon 180mcg Receives: Drug: Clevudine + Peg-interferon |
What is being measured
The primary outcome is the main question the study is designed to answer.
antiviral activity;Proportion of patients with HBV DNA below LOD(HBV DAN levels < 300 copies/mL) by real time PCR
Measured: At week 48
Secondary outcomes (6)
antiviral activity;Proportion of patients with HBV DNA below LOD(HBV DAN levels < 300 copies/mL) by real time PCR
Measured: At week 72
antiviral activity: The change of HBV DNA from the baseline
Measured: Screening, Day1(predose), at week 12, 24, 36, 48, 60, 72
ALT normalization rate
Measured: Screening, Day1(predose), at week 12, 24, 36, 48, 60, 72
Proportion sustained complete response of patients with complete response
Measured: At week 72
Immunological endpoints
Measured: Day1(predose), at week 24, 48, 72
Proportion of patients with HBeAg loss/ HBeAg seroconversion
Measured: At week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2010 (estimated)
- Study startDec 2008
- Primary completionAug 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HBeAg(+) 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bukwang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lee Chang Don, MD, PhD, Principal investigator, The Catholic University of Korea, Uijeongbu St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01264367
- Sponsor's protocol ID
- CMC-403
- Other IDs
- CMC-403
- Status last verified
- Jul 2012
- First submitted
- 19 Dec 2010
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Efficacy and Safety of Clevudine and Peg-interferon in Sequence Compared With Clevudine Alone in the Patients With HBeAg(+) Chronic Hepatitis B or Clevudine and Peg-interferon Sequential Treatment in Patients With Chronic Hepatitis B Who Have HBeAg(+)
- ClinicalTrials.gov ID
- NCT01264367
- Acronym / sponsor ID
- CMC-403
- Conditions
- HBeAg(+) Chronic Hepatitis B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bukwang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Aug 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 21 Dec 2010 (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.
A study to evaluate the efficacy and safety of clevudine and peg-interferon in sequence compared with clevudine alone in the patients with HBeAg(+) chronic Hepatitis B or clevudine and peg-interferon sequential treatment in patients with chronic Hepatitis B who have HBeAg(+)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ClevudineClevudine 30mg |
| 2 | Active comparator | Drug: Clevudine + Peg-interferonClevudine 30mg + peg-interferon 180mcg |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patient is between 18~60 years
- Patient is HBV DNA positive with DNA levels ≥ 5 x 10^5 copies/mL within 30 days of baseline.
- Patient is documented to be HBsAg positive for > 6 months and Patient is HBeAg positive.
- Patient has ALT levels >=80IU/L, prothrombin time(INR)<1.7 and a serum albumin level of at least 3.5 g/dL.
- Patient has hemoglobin levels >=11.5g/dl(if woman) or >=12.5g/dl(if man)
Key exclusion criteria (14 listed)
- Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
- Patients previously treated with interferon, peg-interferon, clevudine, lamivudine, adefovir, entecavir, telbivudine, tenofovir or any other investigational nucleoside for HBV infection.
- Patient is coinfected with HCV or HIV.
- Patient with clinical evidence of decompensated liver disease or HCC
- Patient has WBC levels < 3.0x10^9/L
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 |
|---|---|---|
| ClevudineAlso: Levovir30mg,QD | Drug | 1 |
| Clevudine + Peg-interferonAlso: Levovir + Pagasys30mg, QD(for 24 weeks) + 180mcg,QW(for 24 weeks) | Drug | 2 |
Primary outcome
antiviral activity;Proportion of patients with HBV DNA below LOD(HBV DAN levels < 300 copies/mL) by real time PCR
Time frame: At week 48
6 secondary outcomes
antiviral activity;Proportion of patients with HBV DNA below LOD(HBV DAN levels < 300 copies/mL) by real time PCR
Time frame: At week 72
antiviral activity: The change of HBV DNA from the baseline
Time frame: Screening, Day1(predose), at week 12, 24, 36, 48, 60, 72
ALT normalization rate
Time frame: Screening, Day1(predose), at week 12, 24, 36, 48, 60, 72
Proportion sustained complete response of patients with complete response
Time frame: At week 72
Immunological endpoints
Time frame: Day1(predose), at week 24, 48, 72
Proportion of patients with HBeAg loss/ HBeAg seroconversion
Time frame: At week 48
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 18 Dec 2014.
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.
Lee Chang Don, MD, PhD principal investigator
The Catholic University of Korea, Uijeongbu St. Mary's 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 Clevudine and Clevudine + Peg-interferon in people with HBeAg(+) Chronic Hepatitis B, run by Bukwang Pharmaceutical 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 7 inclusion and 14 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 18 Dec 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 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?
antiviral activity;Proportion of patients with HBV DNA below LOD(HBV DAN levels < 300 copies/mL) by real time PCR (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 18 Dec 2014.