Trial record 13 of 1284 for:
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(+)
Verified July 2012 by Bukwang Pharmaceutical
Information provided by:
First received: December 19, 2010
Last updated: July 24, 2012
Last verified: July 2012
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(+)
HBeAg(+) Chronic Hepatitis B
Drug: Clevudine + Peg-interferon
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||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(+)
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||February 2013 (Final data collection date for primary outcome measure)
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
|Ages Eligible for Study:
||18 Years to 60 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01264367
|Contact: Lee Chang Don, MD. PhD
|Uijeongbu St.Mary's Hospital
|Uijeongbu, Korea, Republic of |
||Lee Chang Don, MD, PhD
||The catholic university of korea, Uijeongbu ST.Mary's hospital
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 19, 2010
||July 24, 2012
||Korea: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 29, 2014
Hepatitis B, Chronic
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections
DNA Virus Infections