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(+)
This study is currently recruiting participants.
Verified July 2012 by Bukwang Pharmaceutical
Sponsor:
Bukwang Pharmaceutical
Information provided by:
Bukwang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01264367
First received: December 19, 2010
Last updated: July 24, 2012
Last verified: July 2012
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Purpose
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(+)
| Condition | Intervention | Phase |
|---|---|---|
|
HBeAg(+) Chronic Hepatitis B |
Drug: Clevudine Drug: Clevudine + Peg-interferon |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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(+) |
Resource links provided by NLM:
Further study details as provided by Bukwang Pharmaceutical:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- antiviral activity: The change of HBV DNA from the baseline [ Time Frame: Screening, Day1(predose), at week 12, 24, 36, 48, 60, 72 ] [ Designated as safety issue: No ]
- ALT normalization rate [ Time Frame: Screening, Day1(predose), at week 12, 24, 36, 48, 60, 72 ] [ Designated as safety issue: No ]
- Proportion sustained complete response of patients with complete response [ Time Frame: At week 72 ] [ Designated as safety issue: No ]
- Immunological endpoints [ Time Frame: Day1(predose), at week 24, 48, 72 ] [ Designated as safety issue: No ]
- Proportion of patients with HBeAg loss/ HBeAg seroconversion [ Time Frame: At week 48 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Clevudine 30mg
|
Drug: Clevudine
30mg,QD
Other Name: Levovir
|
|
Active Comparator: 2
Clevudine 30mg + peg-interferon 180mcg
|
Drug: Clevudine + Peg-interferon
30mg, QD(for 24 weeks) + 180mcg,QW(for 24 weeks)
Other Name: Levovir + Pagasys
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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]
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01264367
Contacts
| Contact: Lee Chang Don, MD. PhD | +82-31-820-3000 |
Locations
| Korea, Republic of | |
| Uijeongbu St.Mary's Hospital | Recruiting |
| Uijeongbu, Korea, Republic of | |
Sponsors and Collaborators
Bukwang Pharmaceutical
Investigators
| Principal Investigator: | Lee Chang Don, MD, PhD | The catholic university of korea, Uijeongbu ST.Mary's hospital |
More Information
No publications provided
| Responsible Party: | Bukwang Pharm.CO.,LTD |
| ClinicalTrials.gov Identifier: | NCT01264367 History of Changes |
| Other Study ID Numbers: | CMC-403, CMC-403 |
| Study First Received: | December 19, 2010 |
| Last Updated: | July 24, 2012 |
| Health Authority: | Korea: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hepatitis B Hepatitis B, Chronic Hepatitis Hepatitis A Hepatitis, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections |
RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections Interferons 2'-fluoro-5-methylarabinosyluracil Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on June 17, 2013