- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01264367
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(+)
December 17, 2014 updated by: Bukwang Pharmaceutical
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Uijeongbu, Korea, Republic of
- Uijeongbu St.Mary's Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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]
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
Clevudine 30mg
|
30mg,QD
Other Names:
|
ACTIVE_COMPARATOR: 2
Clevudine 30mg + peg-interferon 180mcg
|
30mg, QD(for 24 weeks) + 180mcg,QW(for 24 weeks)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
At week 48
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
Screening, Day1(predose), at week 12, 24, 36, 48, 60, 72
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ALT normalization rate
Time Frame: Screening, Day1(predose), at week 12, 24, 36, 48, 60, 72
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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
|
At week 72
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Immunological endpoints
Time Frame: Day1(predose), at week 24, 48, 72
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Day1(predose), at week 24, 48, 72
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Proportion of patients with HBeAg loss/ HBeAg seroconversion
Time Frame: At week 48
|
At week 48
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lee Chang Don, MD, PhD, The catholic university of korea, Uijeongbu ST.Mary's hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (ACTUAL)
August 1, 2013
Study Completion (ACTUAL)
May 1, 2014
Study Registration Dates
First Submitted
December 19, 2010
First Submitted That Met QC Criteria
December 19, 2010
First Posted (ESTIMATE)
December 21, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
December 18, 2014
Last Update Submitted That Met QC Criteria
December 17, 2014
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis B, Chronic
- Hepatitis, Chronic
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Interferons
- Clevudine
Other Study ID Numbers
- CMC-403
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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